Global Blood Therapeutics

Global Blood Therapeutics San Francisco, CA, USA
Mar 18, 2019
Full time
COMMERCIAL IT BUSINESS SOLUTIONS PARTNER Position Summary: The Commercial IT Business Solutions Partner role will provide strategic and operational leadership for applications including CRM, customer master, aggregate spend, case management, data warehouse and analytics. This role will be responsible for business requirements analysisPartner, selection, implementation, and vendor management. The Business Solutions Manager will be the key liaison who will work with the Commercial organization to deliver business process automation and technical solutions to meet the needs of the Commercial team. The Commercial IT Business Solutions Partner will manage projects and oversee delivery of technical solutions that result from the business analysis. This individual will help with prioritization of solution requests and approved projects within Commercial, ensuring that IT activities align with business needs and provide maximum return on investment. They will monitor the performance of IT services consumed by Commercial and partners with service delivery teams to address issues. The ideal candidate has a solid technical background, is well organized and independent and possesses a "can-do" attitude. They must understand the importance of excellent customer service via collaboration and partnership with colleagues in the Commercial organization. Essential Duties and Responsibilities: IT vision & strategy clearly communicated and executed, well aligned to business strategy and IT strategy, and providing competitive advantage to GBT Adherence to budget and demonstration of efficiency initiatives with positive budget impact both within the business and IT Ensure key strategic IT programs are delivered and implemented within agreed and scheduled timelines and adhere to IT quality standards Ensure proper implementation of standards, policies and systems platforms Identify and communicate risks, and propose and implement appropriate action Establish/maintain relationship with Commercial stakeholders, internal technology teams and external technology vendors Drive and implement strategies that leverage technology and partner closely with senior Commercial leaders to align information technology with organizational goals Develop user requirements and vendor/software selection criteria for Commercial software and technology solutions Define process for monitoring and updating solutions based on internal and external insights, market evolution, and changes in brand strategy Manage contract employees to assist with implementation of launch-critical systems Manage application vendors Develop strategic plans and budgets that meet the growth, scale and changing needs of the business Prioritize, oversee, and manage portfolio of IT projects in support of Commercial business goals Ensure delivery of projects within determined time and budgetary constraints Build IT capabilities in Commercial Analytics Support information and data requirements for the Commercial teams while managing compliance requirements Identify opportunities for operational efficiency Contribute to the success of the business and assist in improving the overall customer experience within the team Meet goals and KPIs as set by management Ensure that team's KPIs are monitored, actions are taken, evaluated accordingly and delegated properly Qualifications: Bachelor's Degree in Computer Science/Business Administration or an equivalent level of education and comparable experience 10+ years of industry experience in commercial Biotech, Pharma or Life Sciences Company, preferably launching a product 10+ years of Biopharmaceutical Commercial IT relationship management experience 5+ years of project management experience in successfully delivering complex technology solutions within a defined Software/Systems development lifecycle PMP or fundamental understanding of Project Management a plus 4+ years of experience conducting Business or Systems Analysis Experience developing relationships with and ensuring the appropriate participation of key client stakeholders and client executives Experience in developing strategic system roadmaps Experience with Veeva, Salesforce.com or similar technology platforms is highly preferred Experience with data management and analytics platforms, tools and technologies are highly preferred Strong background in both Waterfall and Agile software development methodology is preferred Experience ensuring compliance to SOX requirements, GxP compliance and validation processes and procedures Exceptional vendor management skills Ability to manage multiple projects, activities and tasks simultaneously Strong communication and interpersonal skills Ability to work in a small, fast-paced IT team Highly motivated with the ability to drive results Familiarity with industry regulations and best practices Ability to distill technical concepts and present to a non-technical audience Strong computer skills (Windows, Word, Excel, Outlook, etc.) Extensive knowledge of Cloud Systems in a Life Sciences Environment Accuracy and responsibility, ability to work with minimal supervision Ability to occasionally work after hours Excellent time management, communication, written and customer service skills Excellent analytical, troubleshooting and decision-making skills Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics Pennsylvania, USA
Mar 18, 2019
Full time
MEDICAL SCIENCE LIAISON - Multiple U.S. Locations Position Summary: Global Blood Therapeutics (GBT) has multiple open MSL positions in the following territories: Florida and Louisianna Texas and Oklahoma Iowa, Indiana, Illinois, Kansas, Kentucky, Minnesota, Missouri, Wisonsin Ohio and Michigan Connecticut and Massachusetts New York City Essential Duties and Responsibilities: Through appropriate scientific exchange, builds and maintains professional relationship with external stakeholders to expand GBT's research, advisory and education partnership opportunities Focus on personal accountability and ownership-constantly challenging oneself to take responsibility for continuous performance improvement and operational excellence; reliable and predictable for colleagues and customers Develop clinical and therapeutic knowledge expertise in the SCD treatment landscape including current treatment strategies, and new therapeutic developments Participate and sometimes lead the development and execution of medical strategies to identify, key SCD experts, investigators and institutions strategic to research and development efforts Develop and ensure alignment in medical education activities for HCPs through MSL-delivered presentations, participation in medical meetings, and other appropriate venues to enhance product and disease state knowledge. Collaborate with GBT clinical team, medical affairs directors, medical monitors and clinical operations to coordinate and optimize educational and research support for sites/investigators participating in GBT's studies. Respond to unsolicited requests regarding interest in investigator sponsored studies (IIS) and supporting IIS submissions through appropriate internal review and approval process. Collaborates with the Senior Director, MSL, Director, MSL and the Senior MSL Payer Lead to provide coverage and build relationships with managed markets, payers and maintain coverage of KOLs/HCPs to execute the medical strategies/tactics. Execute MSLs/MA Key Performance Indicators (MSLs Competencies, Maximize Outreach to Key Stakeholders; Understand & address Disease & product knowledge gaps; Ensure quality responsiveness) Establish medical strategies for implementation by MSL Team, in alignment with Medical Affairs (MA) objectives Coordinates/Collaborates with SR, Director, MSL and the GBT Compliance/Legal colleague to develop and implement policies, SOPs, codes and guidelines, and training Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities Conduct therapeutic training for Sales and medical colleagues upon request Qualifications: A doctorate level degree (e.g. MD, PharmD, and PhD) in life sciences with relevant residency and/or fellowship experience is preferred; however, a relevant life science degree (e.g. RN, MS) is required A minimum of 5 years of experience as an MSL or have 7 + years of experience for a Sr MSL Rare Disease and launch experiences highly preferred Deep knowledge of MSL best practices, legal and regulatory requirements, Codes of Practice, Standard Operating Practices and guidelines is required Demonstrated ability to lead and motivate people, project teams and setting goals Fully understands the roles and responsibilities of MSLs within the industry Consistently networks with MSL industry to ensure alignment with similar MSL organizations and generates new ideas to further grow organizational value Focus on accountability, ownership and excellence Strong scientific and business acumen Strong interpersonal, written and oral communication skills Strong coaching and mentoring skills Capable of managing a diverse group of geographically dispersed staff Strong management skills with demonstrated ability to plan for resourcing needs, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Ability to regularly assess individuals' skills, talents and career interests which ensure development of a talent pool for the future Demonstrates resilience and flexibility while skillfully planning and organizing multiple priorities Has a winning attitude and demonstrates a commitment to goals with a positive approach to problems, even in the face of adversity Anticipates future consequences and trends. Accurately identifies long-range opportunities, and can see opportunities inherent in any situation Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 18, 2019
Full time
QUALITY eDMS / eLMS ANALYST (CONTRACT) Position Summary: The primary responsibility of this position is assisting in the maintenance of the Quality Enterprise Management ecosystem including the electronic Quality Management System. This person will support and have visibility into: Document Management System / Learning Management System / Change Management / Investigation system and overall compliance. Specific responsibilities include: preparing and analyzing data, maintaining documents, supporting data migration, the resolution of root cause investigations, tracking closure, and verification of effectiveness. Essential Duties and Responsibilities: Review incoming requests, identifying and coordinating the necessary next steps to resolve Interface with Quality and Operations to drive timely completion of review cycles, approvals and investigations Support regular business review, including data analysis, identifying trends and insights, and reporting of results Applies systematic problem-solving methodologies and technical skills in identifying, communicating and resolving competing priorities Maintains compliance to internal procedures, FDA, ISO and other regulations Qualifications: Bachelor of Science, or equivalent work experience in While a computer science technical degree is not required, familiarity with technology and the use of IT solutions in business is desired Ability to quickly ramp up knowledge of business and quality management systems Fluency with MS office products, in particular, MS Excel Organized, detail-oriented, able to perform tasks methodically, and can employ critical thinking in problem-solving Ability to manage multiple simultaneous projects with attention to detail and delivery dates Able to escalate risk with the necessary urgency Strong interpersonal skills with the ability to clearly comm
Global Blood Therapeutics Connecticut, USA
Mar 18, 2019
Full time
MEDICAL SCIENCE LIAISON - Connecticut and Massachusetts Position Summary: The Senior MSL position covers the areas of, and can be based in Connecticut and Massachusetts. Essential Duties and Responsibilities: Through appropriate scientific exchange, builds and maintains professional relationship with external stakeholders to expand GBT's research, advisory and education partnership opportunities Focus on personal accountability and ownership-constantly challenging oneself to take responsibility for continuous performance improvement and operational excellence; reliable and predictable for colleagues and customers Develop clinical and therapeutic knowledge expertise in the SCD treatment landscape including current treatment strategies, and new therapeutic developments Participate and sometimes lead the development and execution of medical strategies to identify, key SCD experts, investigators and institutions strategic to research and development efforts Develop and ensure alignment in medical education activities for HCPs through MSL-delivered presentations, participation in medical meetings, and other appropriate venues to enhance product and disease state knowledge. Collaborate with GBT clinical team, medical affairs directors, medical monitors and clinical operations to coordinate and optimize educational and research support for sites/investigators participating in GBT's studies. Respond to unsolicited requests regarding interest in investigator sponsored studies (IIS) and supporting IIS submissions through appropriate internal review and approval process. Collaborates with the Senior Director, MSL, Director, MSL and the Senior MSL Payer Lead to provide coverage and build relationships with managed markets, payers and maintain coverage of KOLs/HCPs to execute the medical strategies/tactics. Execute MSLs/MA Key Performance Indicators (MSLs Competencies, Maximize Outreach to Key Stakeholders; Understand & address Disease & product knowledge gaps; Ensure quality responsiveness) Establish medical strategies for implementation by MSL Team, in alignment with Medical Affairs (MA) objectives Coordinates/Collaborates with SR, Director, MSL and the GBT Compliance/Legal colleague to develop and implement policies, SOPs, codes and guidelines, and training Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities Conduct therapeutic training for Sales and medical colleagues upon request Qualifications: A doctorate level degree (e.g. MD, PharmD, and PhD) in life sciences with relevant residency and/or fellowship experience is preferred; however, a relevant life science degree (e.g. RN, MS) is required A minimum of 5 years of experience as an MSL or have 7 + years of experience for a Sr MSL Rare Disease and launch experiences highly preferred Deep knowledge of MSL best practices, legal and regulatory requirements, Codes of Practice, Standard Operating Practices and guidelines is required Demonstrated ability to lead and motivate people, project teams and setting goals Fully understands the roles and responsibilities of MSLs within the industry Consistently networks with MSL industry to ensure alignment with similar MSL organizations and generates new ideas to further grow organizational value Focus on accountability, ownership and excellence Strong scientific and business acumen Strong interpersonal, written and oral communication skills Strong coaching and mentoring skills Capable of managing a diverse group of geographically dispersed staff Strong management skills with demonstrated ability to plan for resourcing needs, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Ability to regularly assess individuals' skills, talents and career interests which ensure development of a talent pool for the future Demonstrates resilience and flexibility while skillfully planning and organizing multiple priorities Has a winning attitude and demonstrates a commitment to goals with a positive approach to problems, even in the face of adversity Anticipates future consequences and trends. Accurately identifies long-range opportunities, and can see opportunities inherent in any situation Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 17, 2019
Full time
SENIOR MANAGER, HCP MARKETING - Voxelotor Position Summary: Are you interested in driving the launch of a 1st-in-class breakthrough therapy for an underserved patient population with a chronic, life-threatening condition? The Senior Manager, HCP Marketing role will be a critical contributor to the launch of Voxelotor for sickle cell disease. Reporting to the HCP Marketing Lead, this position will develop and execute a disease awareness initiative as well as the brand launch strategy for Voxelotor to drive awareness, perception and utilization. A successful candidate will possess strong marketing competencies, leadership, drive for results and ability to collaborate. Essential Duties and Responsibilities: Develop and execute HCP marketing activities to meet brand objectives and drive disease education, brand awareness, perception and patient starts Translate market research and clinical data into insights and effective initiatives Contribute to brand strategy and launch planning with novel opportunities to establish the brand Lead project management with advertising and media agencies and external vendors to deliver impactful materials within cost and timelines while delivering on brand KPIs Day to day management of vendors (e.g. agency of record) including management of operating budget to ensure appropriate investment and execution of brand tactics Collaborate with Medical, Legal and Regulatory colleagues to ensure an effective and productive promotional review process Assist in development of Sales Training programs and materials Develop and track key metrics to measure success, analyze data, and recommend changes based on results Drive internal stakeholder alignment for your projects and develop strong relationships with cross-functional teams that support the brand Create and support an environment of inclusion and excellence Qualifications: Bachelor's degree in marketing or related fields. Advanced degree preferred Minimum 5+ years' experience in marketing within the pharma or biotech industry Proven success working in complex specialty markets and/or market building in underdeveloped disease areas are a plus Experience on new product launch is a plus Experience developing multi-channel campaigns and programs through all stages from concept to implementation and execution Proficiency in core marketing capabilities such as creative development, value proposition, positioning, segmentation, investment optimization, etc Demonstrated project management capabilities, analytical skillset and acting with initiative Proven ability to influence and solve problems Preference to operate quickly and collaboratively in a fast-paced, demanding launch environment Travel required ~25% (estimated) Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 14, 2019
Full time
ASSOCIATE DIRECTOR, COMMERCIAL SUPPLY CHAIN Position Summary: The Associate Director, Commercial Supply Chain is responsible for management and execution of activities related to the launch and commercialization of Voxelotor, aimed at ensuring the seamless flow of product in a global environment. Scope of responsibilities consist of developing, implementing and maintaining commercial supply chain processes at GBT, including but not limited to serialization, commercial packaging, artwork management, business planning and inventory management. Global Blood Therapeutics (GBT) places a high value on cooperative team dynamics and a positive, "can-do" work ethic. The ideal candidate thrives in a hands-on, fast-paced environment where a strong sense of urgency and accountability is the norm and exceptional communication and interpersonal skills are needed. Essential Duties and Responsibilities: Manage commercial product launch timelines to ensure a timely and successful launch. Responsible for primary and secondary packaging and labeling activities Develop and implement sustainable and robust processes ensuring a successful roll-out, implementation and on-going operation and maintenance of GBT's selected serialization/track and trace solution Partner effectively with GBT's Commercial team to build relationships with selected 3PL provider(s) and establish required processes for efficient product distribution Interface with Supply Chain Planning to coordinate Sales and Operations (S&OP) process Responsible for secondary packaging & labeling activities; leading design and approval activities for generation and implementation of new and revised artwork/printed components with Regulatory, Quality, and packaging sites Identify and implement quality and process improvements across GBT's commercial supply chain Collaborate with Technical Operations group to coordinate global distribution and logistics processes Write and prepare documentation needed for regulatory submissions as required Other duties as required Qualifications: BS/BA degree in related discipline; MBA a plus Typically requires a minimum of 10 years in a clinical or commercial supply chain, manufacturing or contract manufacturing role APICS certification, Lean Six Sigma/Project Management Certification (PMP) a plus Effective project and time management skills Knowledge in supply chain, planning or materials management, inventory management, and business process facilitation in the pharmaceutical, biotech or medical device industries Prior experience in commercial supply launch preparation and execution and ongoing supply chain management in a virtual manufacturing environment is fundamental. Some experience operating in a virtual manufacturing environment in a small to medium-size biotech is highly desirable Previous serialization and aggregation experience. Experience with serialization and aggregation from a business perspective is strongly preferred Understanding of packaging processes, warehouse and distribution operations; experience with contract packaging and/or 3PL distribution operation Working knowledge of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) and other regulatory requirements governing pharmaceutical Supply Chain Prior experience with Sales and Operations Planning (S&OP) processes Experience with Enterprise Resource Planning (ERP) in a pharmaceutical/biotech environment Prior supervisory experience a plus Proficient in Microsoft Suite (Excel, PowerPoint, Project, Visio, Word) Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 13, 2019
Full time
CHIEF COMPLIANCE OFFICER Position Summary: Global Blood Therapeutics (GBT) is seeking a seasoned compliance professional to create and lead the Company's internal healthcare compliance function. The Chief Compliance Officer (CCO) is responsible, for designing, implementing and maintaining an effective Compliance Program, and ensuring that a culture of compliance permeates the organization at all levels. The CCO ensures that the company and its employees comply with applicable healthcare-related laws and regulations. The CCO reviews and evaluates compliance issues/concerns; monitors, audits and reports on healthcare compliance/ethics efforts; and is responsible for building and leading multi-disciplinary efforts within the company related to healthcare compliance. The CCO must exhibit the highest level of integrity and ethics. This position reports to the Chief Legal Officer (CLO) and the Chief Executive Officer. Essential Duties and Responsibilities: Develops GBT's healthcare compliance department, professionals and infrastructure from the ground up (including managing outside vendors as part of our current compliance build), with a particular focus on creating and implementing an effective Compliance Program for all activities relating to healthcare practitioners, patients, medical affairs/MSLs and commercialization Works collaboratively with Legal team partners (especially CLO and VP, Commercial Product Law) and key functions within GBT on all topics relating to healthcare compliance (including marketing/commercial, medical and regulatory affairs, clinical, patient support/advocacy, finance and human resources) Partners with functional teams to establish a rapport and positive working relationship with respect to compliance initiatives at GBT Works collaboratively and creatively with stakeholders and provides broad spectrum compliance support and day-to-day counseling. Clearly and effectively renders practical, timely advice In connection with developing an effective Compliance Program at GBT: Institutes appropriate policies and procedures and ensures its related activities are created, adopted, published, and communicated to staff Develops, coordinates, and administers effective compliance training programs for all appropriate employees and management on pertinent laws, regulations, policies and procedures, including in-depth training of key functions and field personnel Ensures that compliance issues/concerns within the organization are being appropriately evaluated, investigated, and resolved, that there are effective and consistent disciplinary systems and evaluation/ incentive systems that promote legal and ethical conduct Develops and implements auditing, monitoring, and reporting programs Develops and implements period and annual sign-offs as needed under federal and state transparency requirements Establishes and implements periodic risk assessments, audits, and reporting procedures to identify potential areas of compliance vulnerability and risk Develops and implements preventative and corrective action plans to mitigate identified risks. Responds to alleged violations by evaluating or recommending the initiation of investigative procedures, designing and implementing investigative protocols and overseeing investigation processes Partners actively with senior executives to instill a strong culture of compliance at the company through communications and outreach activities Provides reports on a regular basis, and as directed or requested, to keep GBT's Compliance Committee, CLO, CEO and other senior management and the Board of Directors informed of the operation and effectiveness of the Compliance Program Maintains a very strong working knowledge of applicable laws, regulations, and enforcement actions to identify emerging risks Alerts the Company to trends and risks and assists in implementing policies and procedures in response thereto Periodically reviews and updates the Code of Ethics and Business Conduct to ensure continuing relevance in providing guidance to management and employees Manages outside vendors to achieve timely and cost-effective work Qualifications: 10-15 years in-house experience as a compliance professional in the life sciences industry required, preferably at a pharmaceutical or biotech company Broad experience with US healthcare compliance; experience with global compliance preferred Experience with privacy compliance preferred Demonstrated experience launching new compliance programs, from inception to implementation and beyond Excellent communication, negotiation, training and presentation skills and ability to interact with all levels of the organization Strong organizational, project-management and teamwork skills required Self-motivated, innovative, strategic, detail-oriented and able to provide high quality and timely work product Able to manage multiple projects and work successfully in a fast-paced environment under time deadlines Ability to analyze issues and propose options and recommended course of action Ability and track record of successfully working in cross-functional teams Strong client service orientation and business acumen Demonstrated success in a fast-paced, high-performing, fluid, and collaborative culture Ability work to collaboratively with individuals having diverse educational and cultural backgrounds Ability to communicate effectively with personnel at all levels of the organization and to inspire confidence and support for compliance initiatives Strong working knowledge of relevant statutes, regulations, guidances/precedents and trends Proven ability to think strategically about achieving corporate objectives by addressing the needs of internal and external stakeholders Ability to travel as necessary Fit with GBT Culture and Values: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics Florida, USA
Mar 08, 2019
Full time
MEDICAL SCIENCE LIAISON - FLORIDA and LOUISIANA Position Summary: The Senior MSL position covers the areas of, and can be based in Florida/Louisiana. Essential Duties and Responsibilities: Through appropriate scientific exchange, builds and maintains professional relationship with external stakeholders to expand GBT's research, advisory and education partnership opportunities Focus on personal accountability and ownership-constantly challenging oneself to take responsibility for continuous performance improvement and operational excellence; reliable and predictable for colleagues and customers Develop clinical and therapeutic knowledge expertise in the SCD treatment landscape including current treatment strategies, and new therapeutic developments Participate and sometimes lead the development and execution of medical strategies to identify, key SCD experts, investigators and institutions strategic to research and development efforts Develop and ensure alignment in medical education activities for HCPs through MSL-delivered presentations, participation in medical meetings, and other appropriate venues to enhance product and disease state knowledge. Collaborate with GBT clinical team, medical affairs directors, medical monitors and clinical operations to coordinate and optimize educational and research support for sites/investigators participating in GBT's studies. Respond to unsolicited requests regarding interest in investigator sponsored studies (IIS) and supporting IIS submissions through appropriate internal review and approval process. Collaborates with the Senior Director, MSL, Director, MSL and the Senior MSL Payer Lead to provide coverage and build relationships with managed markets, payers and maintain coverage of KOLs/HCPs to execute the medical strategies/tactics. Execute MSLs/MA Key Performance Indicators (MSLs Competencies, Maximize Outreach to Key Stakeholders; Understand & address Disease & product knowledge gaps; Ensure quality responsiveness) Establish medical strategies for implementation by MSL Team, in alignment with Medical Affairs (MA) objectives Coordinates/Collaborates with SR, Director, MSL and the GBT Compliance/Legal colleague to develop and implement policies, SOPs, codes and guidelines, and training Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities Conduct therapeutic training for Sales and medical colleagues upon request Qualifications: A doctorate level degree (e.g. MD, PharmD, and PhD) in life sciences with relevant residency and/or fellowship experience is preferred; however, a relevant life science degree (e.g. RN, MS) is required A minimum of 5 years of experience as an MSL or have 7 + years of experience for a Sr MSL Rare Disease and launch experiences highly preferred Deep knowledge of MSL best practices, legal and regulatory requirements, Codes of Practice, Standard Operating Practices and guidelines is required Demonstrated ability to lead and motivate people, project teams and setting goals Fully understands the roles and responsibilities of MSLs within the industry Consistently networks with MSL industry to ensure alignment with similar MSL organizations and generates new ideas to further grow organizational value Focus on accountability, ownership and excellence Strong scientific and business acumen Strong interpersonal, written and oral communication skills Strong coaching and mentoring skills Capable of managing a diverse group of geographically dispersed staff Strong management skills with demonstrated ability to plan for resourcing needs, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Ability to regularly assess individuals' skills, talents and career interests which ensure development of a talent pool for the future Demonstrates resilience and flexibility while skillfully planning and organizing multiple priorities Has a winning attitude and demonstrates a commitment to goals with a positive approach to problems, even in the face of adversity Anticipates future consequences and trends. Accurately identifies long-range opportunities, and can see opportunities inherent in any situation Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 08, 2019
Full time
MANAGER, COMPUTER SYSTEMS VALIDATION Position Summary: This position is responsible for managing all aspects of Computer System Validation activities at GBT. GBT places a high value on cooperative team dynamics and a positive, "can-do" work ethic. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed. Essential Duties and Responsibilities: Performs and leads CSV projects related to authoring and executing specifications and validation documentation according to the GAMP5 Validation Life Cycle, including: Validation Plan, System Requirement Specification (SRS), Risk Assessments, Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary Reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review Generate validation protocols in line with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations Generate validation plan detailing the scope of work and intent. Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements Ensure all work is in line with the site Master Validation Plan, regulations, procedures and practices Ensure that the site Validation Master Plan remains current and aligned with corporate policies Lead and conduct validation activities in compliance with US and EU regulations (regulations for all countries where have business) Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, CGMP and ISPE GAMP guidelines and regulations Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan Prepare validation summary reports for executed protocols Liaise with other departments (Technical Operations, Clinical Operations, Regulatory Affairs, IT) in execution of the Validation program Communicate Computer System Validation approaches and requirements during audits. Facilitate a continuous improvement culture with other departments at GBT (Technical Operations, Clinical Operations, Regulatory Affairs, IT) Anticipate and assess/prevent technical problems from impacting product and processes Work with Business Owner(s) and System Owner to ensure the validated state of the system with change control activities Manage Computer System Change Control process Track and resolve deviations/exceptions during qualification activities Prioritize qualification activities in line with the project schedules and timelines. Co-ordinate validation/qualification activities with key stakeholders Assist in the development of training material for qualification activities Serve as a Subject Matter Expert to support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork Lead and participate in cross functional teams as defined by the site management team Interpret Regulatory Authority regulations, guidelines and policies Communicate and ensure compliance with Quality objectives, policies and procedures Qualifications: Bachelor's degree in business/technical area or comparable education/experience. Hands-on experience in CSV in the pharmaceutical industry, or related industry. Title and responsibilities to commensurate with experience. Minimum 5 years of experience In depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines Ability to establish clear priorities quickly Ability to work effectively under pressure, handle multiple projects and meet deadlines Ability to lead Computer System Validation projects for the site Ability to write technical documents (Validation plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report etc) Ability to independently identify compliance risks and escalate when necessary Demonstrated leadership in cross-functional and culturally diverse team settings Excellent interpersonal skills with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met High energy, enthusiasm and excellent leadership and management skills Strong verbal and written communication skills, good decision-making skills and time management skills is a must; ability to interface with all levels of the organization Knowledge in risk assessment, gap analysis, changes control and deviation management Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 08, 2019
Full time
SENIOR COMPUTER SYSTEMS VALIDATION SPECIALIST Position Summary: GBT places a high value on cooperative team dynamics and a positive, "can-do" work ethic. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed. Essential Duties and Responsibilities: Performs CSV projects related to authoring and executing specifications and validation documentation according to the GAMP5 Validation Life Cycle, including: Validation Plan, System Requirement Specification (SRS), Risk Assessments, Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary Reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review Draft validation protocols in line with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations Draft a CSV validation plan detailing the scope of work and intent Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements. Ensure all work is in line with Validation Plan, regulations, procedures and practices. Review and execute Computer System Validation protocols Draft risks assessments and applicable test scripts Prepare validation summary reports for executed protocols Liaise with other departments (Technical Operations, Clinical Operations, Regulatory Affairs, IT) in execution of the Validation program Anticipate and assess/prevent technical problems from impacting product and processes Work with Business Owner(s) and System Owner to ensure the validated state of the system with change control activities Participate in and track Computer System Change Controls Track and resolve deviations/exceptions during qualification activities Assist in the development of training material for qualification activities Participate in cross functional teams as defined by manager Communicate and ensure compliance with Quality objectives, policies and procedures Qualifications: Bachelor's degree in business/technical area or comparable education/experience Hands-on experience in CSV in the pharmaceutical industry, or related industry. Title and responsibilities to commensurate with experience. Minimum 2-3 years of experience Knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines Ability to establish clear priorities Ability to work effectively under pressure, handle multiple projects and meet deadlines Ability to write technical documents (Validation plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report etc) Ability to independently identify compliance risks and escalate when necessary Excellent interpersonal skills with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met High energy, enthusiasm and excellent leadership and management skills Strong verbal and written communication skills, good decision-making skills and time management skills is a must; ability to interface with all levels of the organization Knowledge in risk assessment, gap analysis, changes control and deviation management Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 04, 2019
Full time
SENIOR MANAGER, SALES ANALYTICS AND OPERATIONS Position Summary: The Senior Manager, Sales Analytics and Operations will be responsible for supporting and enabling strategic deployment and operational excellence of our field-based organizations; this individual will be a key partner to field leadership and field-based teams. Key areas of accountability may include sales and payer analytics, sales operations, incentive compensation, data and BI strategy and implementation. Essential Duties and Responsibilities: Salesforce Strategy and Analytics Provide strategic, tactical and operational support to field leadership and field-based teams to facilitate and enable execution excellence Inform field force strategy through outputs of sales analysis and insights generation, subnational reporting, KPI development and tracking/monitoring, call plan development, targeting, alignment and segmentation work, sales force size and structure work, promotion response analysis, etc. and other commercial effectiveness initiatives Incentive Compensation- Plan Design, Goal Setting and Administration Partner with senior sales leadership to create customized IC Plan options to reflect unique/complex market dynamics and that drive the desired behavior and motivation End-to-end incentive compensation process including: IC plan design, goal setting, administration, reporting, communication, awards/contests, data integrity/accuracy and IC governance Work closely with Forecast team to set IC forecast Sales Operations Work on the development of sales tools, technology, processes and operations policies, i.e. dashboards, applications, field inquiries- for Sales Leadership, Field Sales, Payer Team Play a key role in CRM implementation as well as enhancement and sustainment work to continually evolve the technology to meet business needs Ensure day-to-day field operations support from HQ Play key role in implementation of Speaker Program Operations and reporting Data Strategy and Governance In collaboration with the a cross-functional team, oversee the ongoing process of managing and evolving our commercial data strategy, data sharing and related governance Play a key role in data acquisition and commercial integration to address key business needs; will establish data as a strategic asset cross-functionally; Responsibilities will include data vendor management, data procurement, data management, i.e. integration/inquiries/quality Implementation and management of commercial technology including DW and MDM system/services Qualifications: Bachelor's degree in business administration, economics, finance or related field 5-7 years of consulting experience; a generalist that has worked across field operations projects including sales analysis, incentive compensation, field operations, commercial data and technology -- supporting clients in the pharmaceutical / biotech industry Must be a problem solver, and is expected to "connect the dots" i.e. think through implications of this teams work to other parts of the business and understand the impact of decisions in other parts of business (in turn proactively address communication/changes) Knowledge and experience partnering with Sales Leadership, Brand Marketing, Commercial Operations, IT, etc. Solid experience with commercial technology (MDM, CRM, data warehousing, i.e. Veeva, Javelin, Tableau, Microstrategy, etc.); deep understanding of standard and emerging commercial secondary data sources, i.e. Xponent, DDD, SP, Claims, etc. Excellent written and verbal communication skills are required - in particular the ability to summarize results and decisions in a concise manner across varying stakeholders Proven history of working and delivering on multiple projects simultaneously, with tight deadlines and changing priorities is required Strong ability to use Microsoft Office (specifically PowerPoint and Excel) and data visualization applications to organize and present quantitative data is required Must be hands on to retrieve data Passionate and visionary about the function and supporting the success of the business Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 04, 2019
Full time
MARKETING AND FIELD OPERATIONS SPECIALIST Position Summary: The Marketing and Field Operations Specialist will provide critical operations support for the Marketing and Field Teams. Essential Duties and Responsibilities: Marketing Operations Function as the Commercial/Materials PRC Specialist and SME with responsibilities including: Collaborate cross-functionally with Regulatory, Medical, Legal, Marketing, CEP, and Agencies as well as MLR Operations Administrator and Training Lead for Veeva Vault/Promo Mats (for key stakeholders and agencies) PRC SOP and Business Process Owner Primary point of contact for PRC submissions Manage PRC submission process including answering questions related to the submission process Review all PRC submissions for completeness and accuracy Track electronic review cycle and adherence to PRC planning calendars and timelines Manage logistics of meetings with PRC members including creation of the meeting agenda and recording comments during discussions Drive adherence with SOPs to improve PRC coordination and streamline PRC work processes Provide input on workflow planning and prioritization Utilize a document management system; maintain records for potential FDA audits, ensuring they are accurate and complete Proofread final submission and print layouts Provide editorial review of marketing materials Assist with FDA audits or other legal issues as needed Establish and manage metrics for PRC Operations Implement key operational capabilities including: Print production operations/support in collaboration with key specialty vendors Materials management operations/support in collaboration with key specialty vendors Ensure print production and materials management order system creation, management and operations optimization Event Planning: Play a key role in Launch Meeting Planning/Logistics in partnership with selected vendor Field Operations Creation, implementation and maintenance of Field Intranet/one-stop application Creation of Field Operations Guide/Resource Development and launch of New Hire Onboarding system/process (that Sales Admin can facilitate) Establish Fleet Vendor Partnership and ensure operations excellence (i.e. Fleet Policy implementation, Fleet Reporting implementation and Fleet Budget/Compliance Optimization) Qualifications: Bachelor's degree 3+ years of operational and administrator support in a biotech/pharma environment with a preference given to those with specific experience and exposure to field operations and marketing operations support Strong operational and process orientation Experience with Veeva Vault/Promo Mats experience is a preferred; some knowledge of the PRC is desired Problem-solver and critical thinker; ability to use a combination of logic, analysis and relevant experience to assess a situation and accurately define the problem and scope of the primary issue Analytical efficiency; ability to multi-task and meet timeliness and accuracy standards by anticipating resources necessary to complete the work Demonstrates influence and communicates persuasively; excellent verbal, written and interpersonal skills with ability to influence and establish effective working relationships with a diverse range of stakeholders Skilled at gaining alignment and support; identifies needs in an effort to build support of a solution or idea and establishes trust through actions Demonstrates initiative; excellent project and task management skills including proactivity, planning, prioritization, objective setting, meeting management and plan execution Proven history of working and delivering on multiple projects simultaneously, with tight deadlines and changing priorities is required Consistently performs at a high level with great attention to detail Strong ability to use Microsoft Office (specifically PowerPoint and Excel) is required Passionate and engaged around supporting the success of the business Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 03, 2019
Full time
DISTRIBUTION AND TRADE LEAD Position Summary: Global Blood Therapeutics is seeking an experienced leader to oversee our U.S. Distribution & Trade functions. This Director/Sr. Director position will report directly to the Chief Commercial Officer. This exciting role provides the opportunity to build, implement and oversee a best in class distribution and trade strategy for exciting product(s) for rare and orphan disease. The Distribution & Trade Lead will leverage GBT's portfolio and his/her professional network to lead the development of all distribution and trade strategies related to making our products available to the patients that need them. This individual will be responsible for developing and overseeing all aspects of product channel strategy including engaging with specialty pharmacies and 3PL/wholesalers. This position will hire and manage a direct report to help accomplish the duties. Essential Duties and Responsibilities: Work cross functionally to determine the optimal strategy for distributing our products to patients. This includes assessing the unique aspects of SCD and developing a cohesive and clear strategy to ensure patients, especially in Medicaid, have appropriate access through our distribution partners Partner with payer team lead to ensure distribution channel is cohesive with payer community Recommend unique distribution models to support closed system health plan and federal payer needs Develop and maintain relationships with specialty pharmacy partners before and after launch Evaluate and determine the best trade strategies with 3PL/wholesalers for GBT and our patients. Execute this strategy to ensure adequate availability and support for our products throughout the channel Represent the function and strategy within the cross functional launch planning team structure to ensure alignment, transparency and support Develop informed, innovative and compliant agreements with specialty pharmacy partners to maximize the distribution of our products to patients Partner with Managed Markets, Patient Support, Marketing and Sales to continually monitor, assess and evolve our distribution strategies and tactics to ensure objectives are met and exceeded Identify, develop and execute on practical compliance/adherence and other patient support programs in conjunction with our Patient Support team that utilize our distribution and trade partners Work with legal and other internal operations functions to draft, implement and execute on compliant contracts with key trade and distribution partners to ensure business objectives are met Plan, lead and execute the Distribution & Trade functional business reviews Work with channel partners to ensure proper purchasing, stocking, and inventory of GBT products to achieve corporate goals in a compliant manner Monitor services agreements to ensure compliance and hold partners accountable to agreements. This includes monitoring customer contacts, service levels, service fees, 852 & 867 data and other business reports. Develop and implement performance metrics and tools such as dashboards and communicate results internally Partner with Patient Support and Managed Markets leadership to develop an appropriate return goods policy. Implement this policy within the distribution channel where necessary and monitor to ensure compliance and that appropriate objectives are met or exceeded Continually monitor weekly sales to ensure purchases are aligned with demand and highlight any discrepancies to be investigated Identify business opportunities in alignment with GBT values and mission. Partner with government price reporting organization and finance to ensure distribution contracts and ensure compliance with current regulatory environment Work cross functionally with manufacturing and quality team on chain of custody and inventory tracking with, or in absence of an ERP system Qualifications: The successful candidate will have extensive product launch experience in the distribution and trade function. A strong working knowledge of/experience with successful distribution models for patients within the state Medicaid systems, and rare and orphan product launch experience is desired. 7+ years of pharmaceutical/biotech experience Significant Distribution & Trade strategy, leadership and execution experience A track record of building and maintaining relationships with key stakeholders and Distribution & Trade partners A keen sense of the policies, regulations and compliance areas that surround this function and will seek to keep the company and our customers safely within them Experience with developing RFPs and leading fair market assessments Account management and contracting experience Proven ability to support financial reporting and an understanding of gross to net implications, of the chosen distribution model Specialty oral product launch experience Strategic thinker experienced in working with commercial and financially oriented issues Demonstrated critical thinking skills and the ability to achieve results. Experience hiring and developing successful people Superior written and verbal communication skills Bachelors' degree required and an advanced degree (e.g. MBA, RPh., PharmD) preferred Able to travel 50-60% of the time to ensure appropriate representation with distribution and trade customers Fit with GBT Culture and Values: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 01, 2019
Full time
IT SERVICE DESK MANAGER Position Summary: Global Blood Therapeutics seeks a hands-on Service Desk Manager to support our continued growth. The Service Desk Manager's role is to oversee all Service Desk staff and ensure that end users are receiving the appropriate assistance. This includes the responsibility of managing all procedures related to identification, prioritization and resolution of incidents, including the monitoring, tracking and coordination of Service Desk functions. The Service Desk Manager is also responsible for planning, designing, and analyzing the organization's service desk according to best practices, while ensuring high levels of customer service quality and availability. This individual will develop, implement, and oversee policies and procedures to ensure consistent service levels and quick resolutions. The Service Desk Manager is also responsible for staffing capacity planning, service process design, performance analysis, and developing proactive resolution plans. The Service Desk Manager will also contribute to escalated problem resolution by giving in-person, hands-on support to end users when necessary. Essential Duties and Responsibilities: Manage the processing of incoming requests to the Service Desk via both telephone and e-mail to ensure courteous, timely and effective resolution of end user issues Analyze performance of Service Desk activities and documented resolutions Track and analyze trends in Help Desk requests to anticipate potential problems and provide proactive resolutions Develop Service Level Agreements (SLAs) to establish problem resolution expectations and timeframes Oversee provisioning of hardware, software and accounts for new employees and contractors Perform system installation, configuration and patch management Develop and enforce request handling and escalation policies and procedures Assess need for any system reconfigurations based on request trends and make recommendations Identify, recommend, develop and implement end user training programs to increase computer literacy and self-sufficiency Oversee development and communication of usage guides and FAQs for end users Oversee the development, implementation and administration of service desk staff training procedures and policies Train, coach and mentor Service Desk staff Contribute to escalated problem resolution by giving in-person, hands-on support to end users when necessary Perform end-user satisfaction surveys and develop action plans to address areas needing improvement Foster relationships with end users and become the champion of end user satisfaction Advance the use of a knowledge base to share information among all levels of IT service and support Leverage service desk best practices and process frameworks, such as ITIL, to drive continual process improvement Promote self-service tools and the knowledge base as mechanisms to improve end-user satisfaction and reduce costs Qualifications: BA/BS in computer science, management information systems, or an equivalent combination of education and experience that demonstrates analytical skills, problem solving, initiative, judgment, decision making and writing ability At least three years managing an IT service and support function in an environment similar in size and complexity to GBT ITIL certification Strong knowledge of GxP and change management of GxP applications in a regulated environment Experience with SOX compliance Proven track record of developing and providing SLAs and Service Desk deliverables Extensive application support experience with Office 365 applications, including Exchange Online and SharePoint Online Expert knowledge of Windows client operating systems and Active Directory. Microsoft certifications a plus Experience with single sign-on solutions and multifactor authentication Knowledge of Zoom Rooms or RingCentral Meeting Rooms a big plus Excellent problem-solving and troubleshooting skills Demonstrated ability to lead by example to improve the troubleshooting skills of Service Desk staff Ability to effectively prioritize and execute tasks in a high-pressure environment. Excellent written, oral, and interpersonal communication skills Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise. Ability to function at a high level in a team setting Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 01, 2019
Full time
SENIOR MANAGER, PATIENT MARKETING Position Summary: Reporting to the Patient Marketing Lead, the Patient Marketing Support position will be a key contributor to the launch of Voxelotor. This position will develop a fully integrated disease awareness initiative as well as a best-in-class launch plan for Voxelotor. The priority for patient marketing strategies, tactics and programs will be to drive patient awareness, activation and engagement with the brand. The position requires strong leadership, communication, and collaboration with cross-functional partners. The Patient Marketing Support position will be responsible for developing, implementing and evaluating promotional materials, programs and activities targeted at patients and caregivers living with Sickle Cell Disease. Essential Duties and Responsibilities: Develop and execute patient and caregiver marketing activities to meet brand objectives and stimulate disease education, brand awareness, patient starts, and product adherence Translate market research and clinical data into effective patient campaigns or programs Lead project management with advertising and media agencies and external vendors to deliver impactful materials within cost and timelines while delivering on brand KPIs Drive internal stakeholder alignment for your projects and develop strong relationships with cross-functional teams that support the brand Collaborate and foster a positive relationship with Medical, Legal and Regulatory to ensure an effective and productive promotional review process Develop key metrics to measure success, analyze data, and recommend changes based on results Manage budgets and closely monitor performance, ensuring cost effective delivery of all programs Operate quickly and collaboratively in a fast-paced, demanding launch environment Champion patient-centricity and share best practices across the organization Create and support an environment of inclusion and excellence Qualifications: Bachelor's degree in marketing or related fields. Advanced degree preferred Minimum 3-5+ years' experience in marketing within the pharma or biotech industry Strong patient focus and knowledge of engagement dynamics along the continuum of care Multicultural patient marketing experience preferred Experience developing multi-channel campaigns and programs through all stages from concept to implementation and execution Proficiency in core marketing capabilities such as creative development, value proposition, positioning, segmentation, investment optimization, etc Excellent project management capabilities, good analytical and conceptual abilities, self-starter initiative and team orientation Must have attention to detail, execution, and follow-through Experience in managing external agency partners to meet deadlines in alignment with SOWs Exceptional communication skills (written, verbal and presentations), time management, planning, project management, organizational and negotiation skills Travel required 25 - 40% (estimated) Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 01, 2019
Full time
SENIOR CLINICAL RESEARCH ASSOCIATE Position Summary: The Senior Clinical Research Associate (Sr. CRA) is a critical position within Global Blood Therapeutics' clinical team. In close collaboration with the Clinical Trial Manager, Clinical Operations & Regulatory Affairs leadership, the Sr. CRA will work to manage and monitor clinical trial sites and will function as the Sr. CRA for clinical trials. The Sr. CRA will partner with GBT's Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and within budget. Assist in managing and or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Essential Duties and Responsibilities: Participate in and may facilitate cross-functional study teams, liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) to accurately coordinate clinical study activities Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables Provide monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reports Accurately update and maintain clinical systems within project timelines Provide regular updates of study progression to CTM, Clinical Development Lead, Program Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues Participate in developing study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance Participate in preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team Work on study feasibility assessments and selection of countries and sites for study conduct Create and conduct training sessions including investigator meetings and team trainings Provide oversight and direction to study team members, including vendors, for study deliverables All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOP's Qualifications: BA/BS degree with at least 2 - 4 years' clinical trial management experience, or advanced degree (MS) with at least 2 years' clinical trial management experience Must have strong knowledge of ICH/GCP guidelines Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring Strong experience in management of CROs and other vendors Proven project management skills and study leadership ability required Must have excellent interpersonal, written and verbal communication skills, and administrative skills Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project Ability to "roll up your sleeves" and individually contribute results to a research and development effort Ability to travel up to 25% Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Mar 01, 2019
Full time
RESEARCH ASSOCIATE, BIOCHEMISTRY AND CELL BIOLOGY Job Summary: The Research Associate, Biochemistry and Cell Biology will play a key role in characterizing novel small molecule drug candidates by performing biochemical and cell-based assays to support SAR related activities. Essential Duties and Responsibilities: Execute biochemical and cell-based screening assays to evaluate drug candidates Responsible for developing, establishing and executing in vitro and ex vivo studies involved in the characterization of lead compounds Develop and optimize novel assays Independently plan, execute and analyze experiments Evaluate and communicate technical information clearly Learn new laboratory techniques, troubleshoot experiments, and ensure experiments are well designed and performed to a high standard Be proactive in troubleshooting technical problems during assay development Qualifications: BA/BS or M.S degree in life sciences or related discipline 2-4 years of laboratory research experience Cell biology and biochemistry background Competency working with blood samples is an advantage Knowledge in basic spectroscopy Experience with data analysis using excel and Prism Ability to evaluate and clearly communicate results The candidate will be expected to work independently and effectively within a team setting, be proactive and design experiments to answer specific scientific questions. Good presentation skills are essential Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Feb 26, 2019
Full time
CLINICAL DATA MANAGEMENT LEAD Position Summary: The Clinical Data Management Lead will oversee the clinical data management function at GBT. Reporting to the Senior Director, Biometrics, you will work closely with Biometrics, Clinical Operations, Clinical Science, and Pharmacovigilance teams to ensure data quality of GBTs clinical trials. As an individual contributor, the successful candidate will be both a strong hands-on executor as well as strategic manager of internal and external partners. Essential Duties and Responsibilities: Provides leadership, mentorship to internal data management staff Provides leadership and direction for outsourced activities Oversees all assigned clinical trials to ensure data quality, integrity and timeliness Works closely with the Study Management Team to set study goals and objectives Responsible for managing, leading and overseeing DM operational activities by ensuring compliance with the corporate timelines and scope of work Accountable for hands-on management of trials and resources while maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standards Supervise, manage, and lead the design, implementation and ongoing practices of clinical DM processes with internal resources and/or vendors Lead vendor and technology evaluation, qualification and selection Manage reconciliations between clinical and safety databases Budget assessment and contract negotiations, training and oversight for all DM services from study start-up through study close-out and final reporting Responsible for managing and tracking work orders associated with clinical DM activities to ensure that the operating costs for the DM department are achieved within budget Creates and maintains positive, cohesive work environment Responsible for the global standardization of DM processes and process improvement and efficiency Database Design: Collaborates with external database developer on the appropriate design of the database Annotates/or reviews CRFs for database developer to use in building the database Writes/or reviews the consistency checks for studies to be programmed in the database Develops/or reviews screen test scripts and consistency check scripts to validate the database Oversees eCRF unit testing and database user acceptance testing Writes/or reviews the Data Management Plan (DMP) and eCRF Completion Guidelines for each new protocol; ensures the DMP and DEG are updated, when appropriate, for each new protocol amendment Ensures appropriate metrics reports and data review listings are available for the study team Discrepancy Management: Develop internal data review plan Oversee data query process for studies in EDC Ensure database is clean and all queries resolved after data have been entered Database Lock: Interacts with Biometrics Team to transfer data for analysis Reviews and prepares data for study team review to ensure data integrity prior to locking Ensures SAE reconciliation is completed Ensures the clinical database is reconciled with all outside sources of data Ensures AEs, medical history, and concomitant medications are coded appropriately (e.g. MedDRA, WHO Drug Dictionary), reviewed and approved Additional Responsibilities: Recommends clinical data management processes and assists to develop department SOPs and Guidelines Qualifications: At least 10 years of experience in Clinical Data Management and a minimum of 4 years prior management experience of external vendors Working knowledge of global clinical trials Thorough knowledge of applicable regulatory rules and ICH guidelines Demonstrated proficiency in data management processes Strong attention to detail Previous CDISC experience is required Proficient in the use of clinical data management systems (e.g. Medidata Rave, InForm) Fit with GBT culture Ability to build strong relationships with co-workers across functions Ability to function at a high level in a team setting whether leading a cross-functional group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Feb 24, 2019
Full time
BUSINESS OPERATIONS MANAGER - QUALITY SYSTEMS Position Summary: The Business Operations Manager - Quality Systems is a skilled individual with life science industry experience. In this role, you'll serve as a cross functional liaison working with Quality, IT, Finance and Technical Operations to drive strategic priorities. You'll also track progress and further develop metrics/OKRs to be reported. Successful candidates for this role will have demonstrated Quality domain expertise. This role reports to the Associate Director, Quality Systems. Essential Duties and Responsibilities: Support efforts to understand requirements, for any new regulations or business systems, conduct gap analyses of system, processes, and supporting documentation, outline impact, define changes required, and support implementation to verify compliance and effectiveness Support cross-functional project planning efforts of GBT projects and programs Support regular reviews, including data analysis, identifying trends and insights and reporting of results Guide Business Owners on best practices to optimize consumption of systems (e.g. release, change management and validation, licenses, renewals and compliance) Provide Organizational Change Management guidance system implementation Act as the advocate to the Vendor for GBT success and business requirement fulfillment Maintain ongoing awareness of industry and organization-wide best practices for quality and share information across the board as necessary Define systems cutover plans and supervise Legacy systems to ensure appropriate transitions, including decommissioning Review and validate data, highlighting and investigating exceptions or potential issues Evaluate how business owners manage their systems investments & identify efficiency and effectiveness gains Align with Business Owners across Operations to establish and optimize business processes Qualifications: Bachelor's Degree Minimum 8 years of experience in Life Sciences Biotech and IT experience Demonstrated experience managing complexity within a Life Science organization Hands-on experience using and/or implementing Quality Management and Enterprise Software Must be able to take complex business and software concepts and articulate them to an audience of varying levels Strong organizational, written and verbal presentation skills are essential Experience working as a consultant Resourceful Self-starter with strong time management skills Management consulting experience is a plus Direct experience working with Regulated Content management systems within Life Sciences is a plus Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.