Global Blood Therapeutics

Global Blood Therapeutics San Francisco, CA, USA
Mar 31, 2020
Full time
COMMERCIAL ANALYTICS SUMMER INTERNSHIP 2020 About GBT: GBT is a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder. The company has introduced Oxbryta™ (voxelotor), the first FDA-approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of SCD. GBT is also advancing its pipeline program in SCD with inclacumab, a p-selectin inhibitor in development to address pain crises associated with the disease. In addition, GBT's drug discovery teams are working on new targets to develop the next generation of treatments for SCD. Job Summary: The Commercial Analytics Summer Intern will work alongside the Senior Manager and Director of Forecasting and National Analytics, focusing on business-critical projects that will maximize Oxbryta's launch potential. This paid internship will last approximately 10-12 weeks beginning in June 2020. Essential Duties and Responsibilities: Gain hands on rare disease launch experience working in a small, fast-paced biotech company Develop predictive models aimed at understanding and improving patient fulfillment, compliance and persistence on Oxbryta Analyze and identify trends and establish opportunities for business impact Deliver strategic recommendations to GBT's commercial leadership Partner with Forecasting and National Analytics, Sales Operations and Market Research teams to further integrate GBT's rich internal data sources into key decision-making processes Qualifications: Currently pursuing a MS in data science, statistics, math, economics, computer science or related field Strong intellectual curiosity Is a self-directed and proactive problem solver with the ability to thrive in a fast-paced, dynamic environment Experienced in writing python/SQL code to pre-process and analyze data to generate actionable insights Excellent interpersonal and communication skills Comfortable using data to tell a story Prior work experience in pharma / biotech is a plus A full-time student in an accredited school with plans to graduate in winter 2020 or later The ability to work on-site 40 hours/week The ability to provide current work authorization The Intern will be responsible for providing their own transportation and housing and are ineligible for employee benefits 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. 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 31, 2020
Full time
SICKLE CELL THERAPEUTIC SPECIALIST (SCTS) - ST. LOUIS, MISSOURI Position Summary: Global Blood Therapeutics is seeking an experienced sales specialist for the launch of voxelotor. The SCTS responsibilities include developing a comprehensive strategic business plan that includes specific, measurable and action-oriented objectives to ensure they achieve/exceed their sales goals. They must demonstrate the ability to target and strategically manage their territory. The SCTS will manage funds and resources efficiently and ethically to maximize sales to ensure ROI. The Sickle Cell Therapeutic Specialist will report directly to the Regional Business Director. This role provides the opportunity to be part of a first in class sales team with responsibility for launching an exciting product that will positively impact and change the course of Sickle Cell treatment. This is a great opportunity to come in on the ground floor and be part of the launch team in a growing entrepreneurial-minded team-oriented environment, where sales performance and territory ownership are paramount. GBT offers competitive base pay, incentive compensation and a comprehensive employee benefits program. Therapeutic Specialist Competencies & Behaviors: Competitive Mindset Business Acumen & Results Orientation : Evaluates and proposes business opportunities while leveraging all available resources and balances priorities to drive results. Resilience & Confidence: Is self-reliant and helps others build their resilience and self-confidence. Customer Focus Build Trusting Relationships: Leverages current relationships and identifies underlying concerns. They are a trusted advisor that both anticipates and addresses customer needs. Clinical Acumen & Learning Agility: Continually builds and applies their own clinical and technical knowledge and is someone sought out for their product and disease state expertise. Account Success Influence with Impact : Effectively persuades others by leveraging complex influence strategies while developing their own resilience and self-confidence. Teamwork and Coordination: Puts the success of the business ahead of personal/professional interests. Works collaboratively with leadership and teammates to support the business. Essential Duties and Responsibilities: Achieve launch excellence as defined by the Launch Scorecard Achieve annual sales goals Understand role, responsibilities, objectives and metrics for success Serve as a role model for compliant behavior that is consistent with the mission, vision and values of GBT Model high touch engagement with all external stakeholders Adhere to assigned territory operational budget Participate in implementation of national and regional sales strategies and tactics Establish and maintain effective communications internally and externally Attend and participate in all Regional and National Sales Meetings Qualifications: 5+ years' experience in the pharmaceutical industry BS/BA Required, MBA Preferred but not required Specialty experienced preferred Hematology experience or knowledge of the hematology market highly preferred Previous experience in launching new products or indications, preferably through a specialty pharmacy Proven successful track record of consistent high performance Strong leadership, planning and organization, analytics, business acumen, decision making and problem- solving skills Ability to prioritize and execute on plan Proven leadership skills with a history of holding oneself to a high level of accountability Ability to influence without authority, internally as well as externally Excellent written and oral communication skills Adherence to GBT's high ethical standards Significant travel may be required Driving is an essential duty of the job; candidates must have a valid driver's license to be considered 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 31, 2020
Full time
MANAGER, PHARMACOVIGILANCE Position Summary: The Manager will be integral in the day-to-day functioning of the Pharmacovigilance team. The incumbent will contribute to a full range of Pharmacovigilance activities including vendor management, operations, and compliance. In addition, he/she will also function in a company matrix environment with several key groups including Biometrics, Clinical Operations, Clinical Science, Quality Assurance, and Regulatory Affairs. Essential Duties and Responsibilities: Ensure all safety reports are triaged, processed, reviewed and submitted accordingly per global regulatory requirements and Global Blood Therapeutics (GBT) standard operating procedures Manage and provide oversight for day-to-day interaction with Pharmacovigilance vendor(s) Track ICSR to completion and adherence to processing timelines Represent Pharmacovigilance in study execution teams for assigned studies Assist with the development and implementation of Safety Management Plans between GBT and Pharmacovigilance vendor(s) Oversee reconciliation of safety data with external teams (Safety vendor, Data Management) Maintain well organized, auditable regulatory files Qualifications: Health care professional (RN, Pharm.D., MD, or equivalent) with, at minimum, 3 years clinical experience or 6+ year of global Drug Safety/Pharmacovigilance experience in pharmaceutical industry Excellent knowledge of FDA, EU and ICH guidelines and regulations governing clinical trials and post-marketing safety Proven ability to manage Pharmacovigilance vendor(s) Knowledge of medical terminology and general principles of adverse event clinical assessment Knowledge of MedDRA dictionary relevant to adverse event and serious adverse event coding Experience with software-based drug safety systems (ARISg a plus, ARGUS, or equivalent) Experience with clinical databases (InForm, eCOS, or equivalent) Excellent communication and interpersonal skills, including ability to work cross-functionally and cross-culturally Excellent written and spoken English Ability to listen and think critically (sometime creatively) Experience in public speaking, a plus Considering only local Candidates *** 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 31, 2020
Full time
SUPPLY PLANNER Position Summary: This position will effectively plan and track cross-functional manufacturing, packaging, logistics and product release activities leading to maintaining commercial and clinical inventory level objectives for GBT products as they are manufactured in GBT's CMO network. This individual will closely collaborate with Technical Operations and Quality Assurance to ensure timely product release. The Supply Planner will manage the Master Production Schedule and its governance process while negotiating with the various GBT functions to ensure adherence to schedule and maintaining inventory level objectives. Essential Duties and Responsibilities: In Coordination with the CMO managers, develop and maintain an accurate Master Schedule for the GBT CMO network within a defined short and medium term production horizon aligned with commercial demand plans and clinical projected demand. Plan, prepare, issue and control production schedules and coordinate with internal stakeholders to meet product release requirements. Responsible for accuracy of the Master Production Schedule and Process Orders dates and quantities. Work closely with Contract Manufacturing Operation Managers to ensure adherence to plan and coordinate changes as needed. Anticipate areas of risk to success and collaborate with management to mitigate. Develop & manage an exceptions & escalation process to determine priorities and quickly resolve production and release conflicts. Partner with CMO Managers, QA, CMC and Demand Planner to fulfill production requirements. Escalates supply issues that may impact product availability to management for further analysis and resolution. Champion appropriate escalation as needed and communicate effectively. Advise management of the status of work in progress, material availability, and potential risks to timelines. Develop and maintain a working relationship with all internal and external stakeholders contributing to product supply. Coordinate interdepartmental activity with Quality Assurance, Manufacturing, Logistics, CMC analytical, purchasing and others as required. Develop and publish related Key Performance Indicators. Qualifications: Bachelor's in Industrial Engineering, Operations Management, Materials Management, Supply Chain or a related field or equivalent experience in the field APICS CPIM certification preferred Minimum 5-7 years in a supply chain planning and scheduling role within the pharmaceutical or medical device industry. Proven leadership capabilities Knowledge of current Good Manufacturing Practices. Ability to develop relationships and interact effectively with all levels of customer and supplier organizations, demonstrating an excellent customer mindset in interfacing with internal departments and suppliers Possesses good organizational skills, a strong attention to detail, and an ability to prioritize tasks within a busy environment Ability to work under time constraints and meet deadlines Proficiency in Microsoft Office suite utilization High Proficiency in MS Office, primarily Excel required Proficiency in Microsoft Project desired Prior experience operating MRP/ERP systems and ability to operate outside them. Excellent written and verbal 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 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 31, 2020
Full time
MANAGER, PHARMACOVIGILANCE Position Summary: The Manager will be integral in the day-to-day functioning of the Pharmacovigilance team. The incumbent will contribute to a full range of Pharmacovigilance activities including vendor management, operations, and compliance. In addition, he/she will also function in a company matrix environment with several key groups including Biometrics, Clinical Operations, Clinical Science, Quality Assurance, and Regulatory Affairs. Essential Duties and Responsibilities: Ensure all safety reports are triaged, processed, reviewed and submitted accordingly per global regulatory requirements and Global Blood Therapeutics (GBT) standard operating procedures Manage and provide oversight for day-to-day interaction with Pharmacovigilance vendor(s) Track ICSR to completion and adherence to processing timelines Represent Pharmacovigilance in study execution teams for assigned studies Assist with the development and implementation of Safety Management Plans between GBT and Pharmacovigilance vendor(s) Oversee reconciliation of safety data with external teams (Safety vendor, Data Management) Maintain well organized, auditable regulatory files Qualifications: Health care professional (RN, Pharm.D., MD, or equivalent) with, at minimum, 3 years clinical experience or 6+ year of global Drug Safety/Pharmacovigilance experience in pharmaceutical industry Excellent knowledge of FDA, EU and ICH guidelines and regulations governing clinical trials and post-marketing safety Proven ability to manage Pharmacovigilance vendor(s) Knowledge of medical terminology and general principles of adverse event clinical assessment Knowledge of MedDRA dictionary relevant to adverse event and serious adverse event coding Experience with software-based drug safety systems (ARISg a plus, ARGUS, or equivalent) Experience with clinical databases (InForm, eCOS, or equivalent) Excellent communication and interpersonal skills, including ability to work cross-functionally and cross-culturally Excellent written and spoken English Ability to listen and think critically (sometime creatively) Experience in public speaking, a plus Considering only local Candidates *** 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 Louisville, KY, USA
Mar 31, 2020
Full time
SICKLE CELL THERAPEUTIC SPECIALIST (SCTS) - LOUISVILLE & CINCINNATI Position Summary: Global Blood Therapeutics is seeking an experienced sales specialist for the launch of voxelotor. The SCTS responsibilities include developing a comprehensive strategic business plan that includes specific, measurable and action-oriented objectives to ensure they achieve/exceed their sales goals. They must demonstrate the ability to target and strategically manage their territory. The SCTS will manage funds and resources efficiently and ethically to maximize sales to ensure ROI. The Sickle Cell Therapeutic Specialist will report directly to the Regional Business Director. This role provides the opportunity to be part of a first in class sales team with responsibility for launching an exciting product that will positively impact and change the course of Sickle Cell treatment. This is a great opportunity to come in on the ground floor and be part of the launch team in a growing entrepreneurial-minded team-oriented environment, where sales performance and territory ownership are paramount. GBT offers competitive base pay, incentive compensation and a comprehensive employee benefits program. Therapeutic Specialist Competencies & Behaviors Competitive Mindset: Business Acumen & Results Orientation: Evaluates and proposes business opportunities while leveraging all available resources and balances priorities to drive results. Resilience & Confidence: Is self-reliant and helps others build their resilience and self-confidence. Customer Focus: Build Trusting Relationships: Leverages current relationships and identifies underlying concerns. They are a trusted advisor that both anticipates and addresses customer needs. Clinical Acumen & Learning Agility: Continually builds and applies their own clinical and technical knowledge and is someone sought out for their product and disease state expertise. Account Success: Influence with Impact : Effectively persuades others by leveraging complex influence strategies while developing their own resilience and self-confidence. Teamwork and Coordination: Puts the success of the business ahead of personal/professional interests. Works collaboratively with leadership and teammates to support the business. Essential Duties and Responsibilities: Achieve launch excellence as defined by the Launch Scorecard Achieve annual sales goals Understand role, responsibilities, objectives and metrics for success Serve as a role model for compliant behavior that is consistent with the mission, vision and values of GBT Model high touch engagement with all external stakeholders Adhere to assigned territory operational budget Participate in implementation of national and regional sales strategies and tactics Establish and maintain effective communications internally and externally Attend and participate in all Regional and National Sales Meetings Qualifications: 5+ years' experience in the pharmaceutical industry BS/BA Required, MBA Preferred but not required Specialty experienced preferred Hematology experience or knowledge of the hematology market highly preferred Previous experience in launching new products or indications, preferably through a specialty pharmacy Proven successful track record of consistent high performance Strong leadership, planning and organization, analytics, business acumen, decision making and problem- solving skills Ability to prioritize and execute on plan Proven leadership skills with a history of holding oneself to a high level of accountability Ability to influence without authority, internally as well as externally Excellent written and oral communication skills Adherence to GBT's high ethical standards Significant travel may be required Driving is an essential duty of the job; candidates must have a valid driver's license to be considered 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 31, 2020
Full time
DIRECTOR, BUSINESS OPERATIONS & ANALYTICS Position Summary: The Director of Business Operations & Analytics is a leadership position within Global Blood Therapeutics' Development Operations team. In close collaboration with the VP of Development Operations this role will influence and facilitate Development Operations oversight strategy and execution of GBT's clinical programs. The Director of Business Operations & Analytics is responsible for the oversight and process improvement of contracting, outsourcing, budgeting, resourcing, vendor management, risk management, and development operations systems (e.g. CTMS, eDC, etc.) This position requires detailed management of timelines, the ability to multitask, and to adapt to rapid change within a complex environment. Essential Duties and Responsibilities: Oversight and implementation of continual process improvement activities/measures In collaboration with Development Operations and QA, develop and implement of quality and process improvement programs In collaboration with Development Operations and QA, identify technology infrastructure needed to support quality improvement programs Oversight and implementation of vendor oversight management and governance infrastructure Review, measure and evaluate data/metrics/key performance indicators to determine impact of the programs on Development Operations Collaborate with all Development functions to assess outsourcing needs, identify potential vendors, manage the RFP/RFI process for vendor selection and facilitate all contracting efforts with selected vendors Work with GBT finance all Development functions Collaborate with Development Operations teams and other functional teams within GBT to identify vendor/clinical site risks and mitigation strategies In collaboration with QA, assist in the preparation and presentation of annual quality trending reports Perform routine review of quality systems and processes to ensure adherence to company standards Oversee and manage vendor meetings Troubleshoots clinical trials and activities Provides leadership and strategy in line with global strategic objectives Qualifications: Clinical Operations/Development leader with greater than 10+ years of international Phase 1-4 trial experience in the pharmaceutical/biotech industry Bachelor's degree required. RN/PA with professional clinical experience, and/or master's degree or higher in health-related science or equivalent preferred She/he will have: Strong communication skills (verbal and written); effective in interaction cross-functionally and with senior management Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues Comfortable executing on multiple projects independently Visionary and passionate about implementing innovation within clinical development An intense drive and organizational expertise are necessary to manage the diverse group of functional activities Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP Knowledge and experience with managing complex clinical development situations GCP inspection preparation and support experience, both clinical site and sponsor GCP inspections Excellent judgment and problem-solving skills Provide direct reports with appropriate coaching, mentoring and development Ability to think creatively, strategically and tactically An entrepreneurial spirit with can do attitude, commitment to teamwork, and initiative Demonstrated ability to lead teams or task forces in the development of Development Operations processes, plans and tools Excellent interpersonal skills Ability to work on problems of diverse scope and extremely complex in nature which may cross many functional areas Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results Familiarity with common Clinical Development metrics, industry-standard performance levels and the implementation of continuous process improvement methodologies (such as Six Sigma, Lean/Kaizen, Quality Function Deployment, etc.) Understanding of multiple regulatory agency requirements as they relate to GBT clinical trials Understanding of vendor management and vendor audits Experience with IT systems commonly used in Clinical Development 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 31, 2020
Full time
MANAGER, FINANCIAL PLANNING & ANALYSIS - CLINICAL Position Summary: The Manager, FP&A - Clinical will support the Chief Medical Officer organization which includes Clinical Development, Clinical Operations, Biometrics and Regulatory functions. This role will report into the Director of FP&A and is focused on forecasting, budgeting, reporting, strategic planning, decision support, accounting close activities, clinical accruals and analytics. This position will support all aspects of Clinical including Clinical Study, external consulting and internal spend forecasting and actuals tracking. Qualified candidates must have the ability to execute multiple work-streams in a fast-paced, dynamic environment and remain open to new projects and/or responsibilities as the business evolves. Candidates must have strong attention to detail, ability to effectively business partner across functions, drive decision making, problem solving, and time management skills. Must be proactive and deadline-oriented. Essential Duties and Responsibilities: Ensure timely delivery and accuracy of monthly and quarterly financial reporting Manage quarterly forecasting and annual budgeting Become a subject matter expert on the GBT clinical pipeline Provide explanations of monthly variances versus expectations to Management Identify, track and analyze key metrics / KPIs that impact the business Tracking and recording of accruals and prepaids as part of the monthly close process Works with external vendors to ensure accruals are accurately reflected Perform financial modeling and ad-hoc scenario analysis Partner with key Clinical Executives and will be the "go to" person for Financial analysis and support to aid in decision making Qualifications: BA/BS degree in Finance, Business or equivalent practical experience 5+ years of experience in biotech industry, specifically in FP&A or Finance Excellent verbal and written communication skills High level of proficiency with Microsoft Excel and clinical modeling A "hand's on" business partner attitude is required; who enjoys challenges and thrives in a demanding environment Self-starter with the demonstrated ability to work in a fast-paced atmosphere and high-profile environment with minimal supervision Resilience and strong target-oriented attitude Focused on solutions, practical implementation and goals Good understanding of finance terminology, concepts and tools NetSuite background a plus Experience with FP&A Planning system a must (Adaptive Insights 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.
Global Blood Therapeutics South San Francisco, CA, USA
Mar 31, 2020
Full time
SENIOR LOGISTICS SPECIALISTS Job Summary: This position will coordinate day to day activities necessary to ensure timely shipments of Global Blood Therapeutics (GBT) products, from starting materials to finished products, including lab samples. This position will coordinate global shipment and logistics, ensuring all required documentation is in place and all activities are efficiently coordinated. The Sr. Logistics Specialist will also support inventory management strategies, and the development and maintenance of shipping profiles. Essential Duties and Responsibilities: Maintain transportation structure for GBTs products. Develop and maintain GBT product shipment profiles, evaluate proper shipment lanes Coordinate and manage distribution networks and logistics and transportation activities for all material types raw and starting materials, drug substance, drug product and finished product Coordinates freight movement from origin to destination including all follow through to delivery (place orders, appointment confirmations, tracking as needed) Coordinate global Import/Export process and related documentation with Contract Manufacturing Organizations (CMOs), couriers and customs brokers Assist in identifying and implementing continuous improvement of shipping processes and procedures, implement key process indicators as required to ensure and effective and compliant GMP supply chain Main point of contact for external warehouse operations, coordinating receiving and shipping transactions Oversee transportation couriers, collect and analyze global freight spend and communicate trends to management Coordinate availability of documentation including Pro-forma and Customs invoices, packing lists Effective cross-functional collaborator and communicator. Interface with GBTs Technical Operations, Analytical Development, Quality Assurance and others as required Assist in selecting proper transportation carriers, including contracts and Power of Attorney approval, drafting of procedures and continued oversight of approved transportation vendors Support Supply Chain department in material planning and inventory control activities Additional projects and responsibilities as required Qualifications: Bachelors in Operations, Materials Management, or a related field or equivalent experience in the field CPIM, DOT, IATA DGR certifications a plus Minimum 3-5 years in a supply chain, warehouse/ logistics role within the pharmaceutical industry, with hands-on experience in managing all aspects of transportation and delivery for domestic and international locations Must have experience with customs management and FDA cargo inspections Cold Chain logistics experience Experience with global distribution and logistics, hazardous material transport, carrier selection and management, temperature-controlled transportation requirements Basic knowledge of current Good Manufacturing Practices and Good Distribution Practices (GDP) compliance Ability to develop relationships and interact effectively with all levels of customer and supplier organizations, demonstrating an excellent customer mindset in interfacing with internal departments and suppliers Possesses good organizational skills, a strong attention to detail, and an ability to prioritize tasks within a busy environment Ability to work under time constraints and meet deadlines Proficient in Microsoft Office suite utilization Excellent written and verbal 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 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 31, 2020
Full time
PROJECT TOXICOLOGIST Position Summary: Global Blood Therapeutics (GBT) is a clinical-stage biopharmaceutical company determined to discover, develop, and deliver innovative treatments that provide hope to underserved patient communities. We are seeking for a toxicologist to lead safety strategies for small molecule discovery programs while interacting with research and development teams. This position reports to the Head of Toxicology. Essential Duties and Responsibilities: Serves as Project Toxicologist on project teams in Research Develops candidate selection screening strategies, as well as designs, implements, and oversees screening studies at CROs Collaborates with Research to develop critical pathways to select development candidates Leads investigative toxicology studies as needed Works closely with Toxicology Study Manager to ensure timely completion of nonclinical studies with attention to quality Serves as Study Monitor as needed Maintains awareness of current and emerging standard practices and guidelines in the field Qualifications: PhD or equivalent in toxicology, pharmacology, or related discipline, preferably with DABT certification Experience in the pharmaceutical industry (minimum of 3 to 5 years) Experience in drug discovery/discovery toxicology, managing small molecule drug candidates Experience with predictive toxicology methods preferred Ability to work with interdisciplinary teams Excellent communication skills Excellent organizational and time management skills Experience with managing studies conducted at CROs 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 31, 2020
Full time
CONTRACT - INFORMATICS APPLICATION ANALYST Position Summary: Under general supervision, the Contract Informatics Application Analyst will take charge of user training and data management tasks; author user guide and video tutorials; perform user training; enter and correct data in the database; assist users with the use of Informatics tools; document scientific workflows and data pipelines. Essential Duties and Responsibilities: Document GBT Research operations, scientific workflows, and data pipelines Document the functions, features and steps of using the tools, and compile them into user manuals Author visual training slides and record video training materials Perform regular group training or ad hoc individual training of end users Assist users with data entry and query/report Conduct data entry, quality check and correction Gather and document user feedback and communicate to Informatics Group Perform user test of informatics applications and tools Receive, triage, address incoming support requests from Research Qualifications: B.S. in any STEM discipline Familiarity with chemistry/biology or life science research activities Proficiency with MS Office tools and web applications Excellent written skills and interpersonal skills Strong technical trouble shooting skills Self-motivated and desire to learn new knowledge and skills Familiar with Software/System Development Life Cycle (SDLC) Be flexible and a team player Desirable (not required): familiar with computer programming, e.g., Visual Basic or Java
Global Blood Therapeutics San Francisco, CA, USA
Mar 31, 2020
Full time
SUPPLY PLANNER Position Summary: This position will effectively plan and track cross-functional manufacturing, packaging, logistics and product release activities leading to maintaining commercial and clinical inventory level objectives for GBT products as they are manufactured in GBT's CMO network. This individual will closely collaborate with Technical Operations and Quality Assurance to ensure timely product release. The Supply Planner will manage the Master Production Schedule and its governance process while negotiating with the various GBT functions to ensure adherence to schedule and maintaining inventory level objectives. Essential Duties and Responsibilities: In Coordination with the CMO managers, develop and maintain an accurate Master Schedule for the GBT CMO network within a defined short and medium term production horizon aligned with commercial demand plans and clinical projected demand. Plan, prepare, issue and control production schedules and coordinate with internal stakeholders to meet product release requirements. Responsible for accuracy of the Master Production Schedule and Process Orders dates and quantities. Work closely with Contract Manufacturing Operation Managers to ensure adherence to plan and coordinate changes as needed. Anticipate areas of risk to success and collaborate with management to mitigate. Develop & manage an exceptions & escalation process to determine priorities and quickly resolve production and release conflicts. Partner with CMO Managers, QA, CMC and Demand Planner to fulfill production requirements. Escalates supply issues that may impact product availability to management for further analysis and resolution. Champion appropriate escalation as needed and communicate effectively. Advise management of the status of work in progress, material availability, and potential risks to timelines. Develop and maintain a working relationship with all internal and external stakeholders contributing to product supply. Coordinate interdepartmental activity with Quality Assurance, Manufacturing, Logistics, CMC analytical, purchasing and others as required. Develop and publish related Key Performance Indicators. Qualifications: Bachelor's in Industrial Engineering, Operations Management, Materials Management, Supply Chain or a related field or equivalent experience in the field APICS CPIM certification preferred Minimum 5-7 years in a supply chain planning and scheduling role within the pharmaceutical or medical device industry. Proven leadership capabilities Knowledge of current Good Manufacturing Practices. Ability to develop relationships and interact effectively with all levels of customer and supplier organizations, demonstrating an excellent customer mindset in interfacing with internal departments and suppliers Possesses good organizational skills, a strong attention to detail, and an ability to prioritize tasks within a busy environment Ability to work under time constraints and meet deadlines Proficiency in Microsoft Office suite utilization High Proficiency in MS Office, primarily Excel required Proficiency in Microsoft Project desired Prior experience operating MRP/ERP systems and ability to operate outside them. Excellent written and verbal 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 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 31, 2020
Full time
SENIOR LOGISTICS SPECIALISTS Job Summary: This position will coordinate day to day activities necessary to ensure timely shipments of Global Blood Therapeutics (GBT) products, from starting materials to finished products, including lab samples. This position will coordinate global shipment and logistics, ensuring all required documentation is in place and all activities are efficiently coordinated. The Sr. Logistics Specialist will also support inventory management strategies, and the development and maintenance of shipping profiles. Essential Duties and Responsibilities: Maintain transportation structure for GBT's products. Develop and maintain GBT product shipment profiles, evaluate proper shipment lanes Coordinate and manage distribution networks and logistics and transportation activities for all material types - raw and starting materials, drug substance, drug product and finished product Coordinates freight movement from origin to destination including all follow through to delivery (place orders, appointment confirmations, tracking as needed) Coordinate global Import/Export process and related documentation with Contract Manufacturing Organizations (CMO's), couriers and customs brokers Assist in identifying and implementing continuous improvement of shipping processes and procedures, implement key process indicators as required to ensure and effective and compliant GMP supply chain Main point of contact for external warehouse operations, coordinating receiving and shipping transactions Oversee transportation couriers, collect and analyze global freight spend and communicate trends to management Coordinate availability of documentation including Pro-forma and Customs invoices, packing lists Effective cross-functional collaborator and communicator. Interface with GBT's Technical Operations, Analytical Development, Quality Assurance and others as required Assist in selecting proper transportation carriers, including contracts and Power of Attorney approval, drafting of procedures and continued oversight of approved transportation vendors Support Supply Chain department in material planning and inventory control activities Additional projects and responsibilities as required Qualifications: Bachelors in Operations, Materials Management, or a related field or equivalent experience in the field CPIM, DOT, IATA DGR certifications a plus Minimum 3-5 years in a supply chain, warehouse/ logistics role within the pharmaceutical industry, with hands-on experience in managing all aspects of transportation and delivery for domestic and international locations Must have experience with customs management and FDA cargo inspections Cold Chain logistics experience Experience with global distribution and logistics, hazardous material transport, carrier selection and management, temperature-controlled transportation requirements Basic knowledge of current Good Manufacturing Practices and Good Distribution Practices (GDP) compliance Ability to develop relationships and interact effectively with all levels of customer and supplier organizations, demonstrating an excellent customer mindset in interfacing with internal departments and suppliers Possesses good organizational skills, a strong attention to detail, and an ability to prioritize tasks within a busy environment Ability to work under time constraints and meet deadlines Proficient in Microsoft Office suite utilization Excellent written and verbal 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 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 Chicago, IL, USA
Mar 31, 2020
Full time
MEDICAL SCIENCE LIAISON - Midwest - IL, MO, IN Position Summary: The Medical Science Liaison (MSL) will participate in the strategic development and tactical execution of plans to engage scientific thought leaders and act as a conduit for providing accurate and updated clinical, scientific and medical information to Health Care Professionals and other members of the scientific community. The MSL will provide non-promotional scientific, educational, and research support for the Global Blood Therapeutics (GBT) product portfolio, in particular for Voxelotor, for the treatment of sickle cell disease (SCD). The MSL will provide field-based medical support for GBT's clinical research programs, registries and facilitation of the investigator sponsored trials process. The MSL will provide requested, clinical and scientific information to KOLs, HCP's academia, payer, government organizations, community-based patient organizations and other members of the healthcare community in compliance with all relevant company policies. This is a home-office based position. 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 · Develop clinical 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 healthcare professionals through MSL-delivered presentations, participation in medical meetings, and other appropriate venues to enhance product and disease state knowledge · Collaborate with the GBT clinical team, medical monitors and CRA's to coordinate and optimize educational and research support for sites/investigators participating in GBT's clinical trials · Respond to unsolicited requests regarding interest in investigator sponsored studies (ISS), and supporting ISS submissions through appropriate internal review and approval processes · Ensure alignment on content of effective clinical presentations provided to internal and external audiences, ensuring presentations are tailored to meet the specific needs of the audience (appropriate response to unsolicited requests) · Ensure efficient information exchange between MSL colleagues in the field and office-based clinical, medical affairs, and drug safety team members, so that key clinical, safety and research issues are identified and communicated to and from industry leaders and the appropriate GBT departments to help shape company research, development, and strategies for investigational and commercialized products · Identify educational needs within the medical community around the SCD state management · Maintain clinical expertise through comprehensive education including attendance at relevant symposium, scientific workshops, and review of key journals; and where applicable participation in required internal training, and presentations · Adhere to all regulatory and compliance guidelines and company policies in all aspects of scientific dissemination of information, including responses to unsolicited requests for medical information · Serve as a liaison between HCP's and KOL's and GBT Medical Affairs · Participate in KOL planning · Mentors other MSL team members · Assist and augment in the training and development of Medical colleagues, regional field-based MSL's and Sales teams · Support development of appropriate responses to unique inquires as required in the areas of scientific evidence and medical education, etc. Qualifications: · An advanced degree in life sciences (MD, PharmD, PhD or equivalent) is preferred with a minimum of 3-5 years of experience as an MSL, with 3 years in the field as an MSL or in a comparable role · Has an established and demonstrated track record of effective and influential oral presentations with the healthcare profession · Has excellent leadership, management and negotiation skills. The ability to work in a fast-paced and dynamic environment · Ability to influence and work effectively across functions and operate in a matrix environment · Demonstrated 3 year's minimum of therapeutic research or substantive patient care experience is required · Launch experience preferred · Prior experience in rare disease required · Ability to travel 60-70% · No relocation required (home-office based) 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 31, 2020
Full time
CONTRACT - SENIOR CLINICAL QUALITY ASSURANCE SPECIALIST Position Summary: This contract position will assist the Sr Director of QA and Associate Director Clinical QA in providing Clinical Quality Assurance (CQA) support to GBT Clinical Operations as required to ensure that operations and documentation are compliant with relevant regulations, ICH guidance, GBT SOPs and study procedures. The CQA Specialist will also administer the GBT CQA Audits and CAPA Tracking System, including tracking CAPAs through closure per observations documented as result of Internal and External GCP Compliance Audits. Essential Duties and Responsibilities: Participate in QA department meetings Participate in cross-functional project meetings Collaborate with stakeholders and IT to configure the Audits and CAPA Tracking System Contribute to the development of QA SOPs/Work Instructions to support the Audits and CAPA Tracking System Maintain the CQA Audit and CAPA Tracking System Support the development of Clinical Operations SOPs/Work Instruction and other tools to ensure compliance with applicable regulations and GBT records retention policies and practices Provide guidance to ensure the eTMF is managed in accordance with relevant regulations, ICH-GCP guidelines and GBT SOPs: Evaluate new study requirements; verify appropriate eTMF structure is developed prior to start-up and is based on the current DIA TMF Reference Model Verify Clinical Personnel are trained on the eTMF System and relevant SOPs Verify Clinical Personnel are assigned eTMF User roles and permission sets Ensure the eTMF is maintained with an inspection-ready strategy Performs and documents interim, and close-out eTMF audits when requested Participate in audits and/or inspections of Clinical Operations and the eTMF Support Sr QA during preparation for and conduct of Internal Audits at GBT Support Sr QA/contracted Auditor during preparation for and conduct of External Audits at clinical vendors and sites Reports to Associate Director Clinical QA Qualifications: Associates/Bachelor's degree in a relevant discipline preferred Minimum of 3 years (7 years for Sr CQA Specialist) of progressively responsible experience in a pharmaceutical, biotechnology or related environment in roles focused on clinical trial compliance and documentation Demonstrated understanding of the clinical drug development process and clinical trial methodology Demonstrated current knowledge of ICH, GCP and other regulatory guidance as applicable to management of clinical documentation Demonstrated ability to assess current and future business needs to ensure the clinical documentation is strategically and operationally positioned to properly support company objectives Proficiency with Essential Documents per ICH E6(R2) Experience with Electronic Trial Master File (eTMF) Systems Experience with the Drug Information Association (DIA) Trial Master File Reference Model Demonstrated understanding of records management best practices Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects Able to attend off-site audits/meetings/training/conferences as needed Experience with developing and implementing SOPs, Work Instructions, other training Experience managing electronic systems Experience working directly with Monitors Experience with Inspections by a Regulatory Authority 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
Global Blood Therapeutics San Francisco, CA, USA
Mar 31, 2020
Full time
ASSOCIATE DIRECTOR, MEDICAL INFORMATION Position Summary: The Associate Director, Medical Information will be responsible for growing and leading a medical information function for Global Blood Therapeutics' (GBT) clinical product(s), trials and pipeline drugs, which will enable the company to realize its mission of delivering best-in-class medicines to patients with grievous blood disorders. This individual will display an understanding of the key role medical affairs plays in enhancing the safe and effective use of drugs and educating clinicians and patients regarding their use. Additionally, he/she will support the clinical and commercial vision and provide cross functional support. This individual will have strategic and operational responsibilities for all aspects of medical information. Essential Duties and Responsibilities: Primary accountability for providing responses to unsolicited medical inquiries across the GBT product portfolio Develop and lead day-to-day operations for a Medical Information function at GBT, including creating and updating high-quality standard response letters and FAQs documents as assigned Provide ongoing management of call center vendor Deliver medical Information Insights to help inform medical priorities, strategies and tactics Ongoing evaluation and literature surveillance across relevant therapeutic area(s) Collaborate with the Preclinical, Clinical Development, and Medical Affairs teams to translate data evidence into medical information materials Collaborate closely with the Medical Science Liaison team to gain input and alignment on the development of medical information deliverables Supports Promotional/Medical review Committee meetings by participating in the review and approval of promotional/medical materials to ensure medical accuracy. Serve as the Veeva librarian for referencing, content creation, review, etc. Provides coverage for the Medical Information booth at US medical conferences Other duties and responsibilities as assigned Qualifications: A medical or scientific degree (PharmD, PhD, DO, MD, MS or RN) preferred with 4-6+ years of Medical Information or Medical Communications experience. Experience in the hematology therapeutic area desired Excellent verbal and written communication skills, including strong attention to detail. Proficient with evaluating and reporting complex scientific and clinical data and translating them into simple messages. Ability to quickly understand a disease landscape Must have proven experience working in a matrixed environment and be an effective collaborator either in the biotech/pharma industry or at a Medical Communication/Medical Information agency Strong knowledge of regulatory/compliance regarding promotion, Pharma guidelines and all other relevant industry standards Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues Comfortable executing on multiple projects independently through all project aspects from strategic to tactical, to ensure timely completion of assignments Expert use of secondary literature databases (Medline, Embase), reference management software (EndNote), Microsoft Word, PowerPoint, and Outlook applications 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 30, 2020
Full time
DIRECTOR, CLINICAL DEVELOPMENT OUTSOURCING Position Summary: The Director of Development Outsourcing is a leadership position within GBT's Clinical Development team. The Director is accountable for delivery of a clinical program(s). In collaboration with the VP of Clinical Operations, the Director will influence and implement the development operations outsourcing strategy and execution for GBT's clinical development program(s). Essential Duties and Responsibilities: Author, negotiate, execute and manage the documents needed to affect the selection of the optimal external service provider (ESP) Collaborate with Legal and Finance to lead the resolution of complex contractual and budgetary issues Negotiate contract terms, scopes of work, pricing and payment schedules. Ensure agreements are commercial advantageous to GBT while minimizing risk through close collaboration with functional partners such as legal, finance, and clinical Assist clinical teams in defining scopes of work (SOW) and preparing Study Specification Worksheets (SSWs) for both original contracts and amendments Assist clinical teams in budget development Lead identification and selection of clinical operations vendors Serve as issue escalation point for vendor, including, clinical CRO, issues Collaborate with Business Operations & Analytics team for continued process improvement and ongoing ICH/GCP maintenance Manage direct reports and recruit future internal FTEs and consultants/contractors Contribute to the planning and implementation of clinical development program including scenario planning, forecasting enrollment and timelines, assessment program level feasibility, estimation of resources and budget, and development of operational strategies Contribute to developing department processes to ensure adherence to GBT's standards, and all applicable regulations and guidelines Contribute to the development and maintenance of the necessary resource and budget forecasting for Clinical Operations All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs Secure all necessary approvals to ensure compliance to SOX and company procedures Report out on a set cadence tracking metrics and suggested process improvements Manage traffic of contractual documents to ensure timely and compliant execution Ensure Vendors/Partners are delivering in line with expectations and contracts Participate in initiatives to drive clinical development objectives Adhere to GBT's Working Practices, and Standard Operating Procedures (SOPs) Establish and maintain clinical forecasting processes including long-term strategic planning, annual planning, monthly rolling forecasts and in-month monitoring Partner closely with other development functions to develop thoughtful forecasts and gain insights into revenue drivers/shifts Help establish and direct KPIs to measure vendor performance Create monthly business updates for management based on KPis, providing insight into any trends or shifts in the business Identify and quantify financial/operational risks and opportunities to the business Work to continuously improve, automate and scale forecasting processes and methodologies Develop and standardize financial reports Drive ad-hoc business projects as necessary Work closely with clinical and finance to develop a monthly accrual process to provide timely and accurate clinical cost accruals Qualifications: Bachelor's degree required. Master's degree or higher in business an/or health-related science or equivalent preferred More than 10 years of experience managing the outsourcing of Phase 1-4 clinical trials, both domestically and internationally Experience managing direct reports Excellent organizational skills and attention to detail Effective communication and interpersonal skills Ability to efficiently perform multiple tasks and manage changing priorities 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 30, 2020
Full time
PROCUREMENT SOURCING MANAGER Position Summary: This position reports to the Associate Director of Procurement. The Procurement Sourcing Manager is responsible for all activities related to ongoing supplier management and the procurement of services, materials, and supplies. Individual tasks include negotiations, control costs, insuring continuous and efficient processing. The Procurement Sourcing Manager will maintain and update policies and procedures to ensure that procurement activities are in accordance with Corporate Internal Controls. Candidates must have strong experience managing global suppliers, exceptional negotiation experience, knowledge of global procurement practices, contracts, laws and regulations, and the ability to lead cross-functional project teams as well as the capacity to contribute consistently and positively in a high-paced, fast-changing and sometimes unpredictable environment. Essential Duties and Responsibilities: Oversight of the daily operations of the Procurement function and serve as the hands-on leader that understands and performs the daily tactical and strategic functions Manage and improve the Procure to Pay process ensuring training, policy development, executed documentation, data entry, submission, order expediting, change orders, receiving and reconciliation of related system issues Lead supplier engagement processes including conducting vendor due diligence, RFx, negotiations and vendor management across a variety of categories - with a focus on indirect categories such as Commercial, Marketing, IT and Facilities Collaborate with business owners to develop accurate scopes of work, including gathering product and service specifications; implement supplier management programs to ensure continuous improvement and monitoring Support the Strategic Sourcing execution of budgeted spend that accomplish key objectives which include savings, operational improvement, supplier consolidation or diversification, risk management or improving spend visibility Deliver spend analysis and insightful market research and metrics to develop a sourcing roadmap with internal partners Negotiate all commercial terms and conditions with suppliers for the procurement and delivery of materials, tools, equipment and services with minimal support from Legal team Assist in the development of award scenarios and recommendations for partner evaluation, consideration and decision-making Key contact for vendors, focused on building strong collaborative vendor relationships Identification and realization of cost-saving and cost-reduction opportunities and build a culture of long-term savings on procurement costs without compromising supply assurance or quality Follows and complies with the Procure to Pay Narrative and SOX processes set forth by GBT Point of contact for invoices reconciliation of accounts payable and receiving discrepancies Provide training and day-to-day support on procurement systems, policy and processes for business unit and/or corporate staff involved in purchasing activities Works closely with FP&A, IT, Facilities, Legal, AP, Commercial, Clinical and Tech Ops Manages the annual Fixed Asset process Complies with company health and safety policies and procedures Qualifications: BS/BA degree in related discipline Require a minimum of 4 to 6 years of related experience Biotech/Clinical Procurement experience, a plus Is preferred certification in assigned area i.e.: Dangerous Goods Shipping, Import and Export Documentation Performs a variety of complicated or multi-layered tasks Outstanding organization and detailed oriented skills Applies strong analytical and effective business communication skills eProcurement system skills, with Zycus and Netsuite is a plus Proficient in Microsoft Office with a focus on Analytical 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 San Francisco, CA, USA
Mar 30, 2020
Full time
EXECUTIVE ASSISTANT, BUSINESS AND STRATEGY Job Summary: Reporting to the Chief Business & Strategy Officer, the Executive Assistant provides administrative support to the Chief Business Officer and her organization, including Corporate Development and Government Affairs & Policy, and helps ensure the smooth operations of the Executive Office. The successful candidate will be extremely well organized, an excellent communicator, capable of effectively managing complex schedules, skilled at interfacing with key external audiences including the Board of Directors and external partners, have excellent judgment and discretion, and works collaboratively with other members of the GBT administrative team to coordinate various activities. Over time, the Executive Assistant will be able to anticipate many of the needs of the team and will be proactive in the execution of those needs. Essential Duties and Responsibilities: Provide administrative support to the CBO, Corporate Development, and Government Affairs & Policy teams Manage and maintain calendars, arrange travel, travel expenses, organize meetings Maintain budget tracking, vendor set-up including generating POs and finalizing agreements Organize confidential meetings, including travel arrangements, for prospective external partners Manage meeting calendars for key conferences Create and edit PowerPoint presentations Handle special projects as requested (such as GBT Women's Group social and speaker events) Support departmental communications and communications within the Corporate Development and Government Affairs & Policy groups, as well as with internal and external clients Qualifications: At least ten years of experience in the biopharmaceutical industry, including experience supporting a C-level executive Highly-developed interpersonal skills including communication and listening skills, attitude, exhibiting a professional, proactive, optimistic, and calm demeanor Excellent verbal and written skills and attention to detail Ability to juggle multiple priorities and manage complicated calendars across multiple executives and external personnel Demonstrated judgment and discretion with confidential company information Proactive approach to business needs and requirements Ability to work independently and be flexible, adjusting priorities and tasks in real time to support the objectives of the departments Successful experience in fast-paced, high growth environment High proficiency with various applications including: PowerPoint, Word, Excel, Outlook, as well as Concur, vendor/PO software programs Manage domestic and international meeting and travel arrangements that may often require changes and prepare expense reports Previous experience supporting Corporate/Business Development or Government Affairs/Policy functions 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.
Global Blood Therapeutics San Francisco, CA, USA
Mar 30, 2020
Full time
ASSOCIATE DIRECTOR, HEALTH ECONOMICS AND OUTCOMES RESEARCH (HEOR) Position Summary: Global Blood Therapeutics (GBT) is seeking a talented individual to join its Health Economics and Outcomes Research group in South San Francisco, CA. The primary responsibility of the Associate Director is to execute strategic plans to optimize the supporting evidence and value demonstration of GBT's leading product, Voxelotor, in sickle cell disease products. This position reports to the Senior Director of HEOR at GBT. Essential Duties and Responsibilities: Assist in the design, development, and execution of health economic and outcomes research tactics to support lifecycle management of Voxelotor and demonstrate value to key stakeholders Help to manage the integration of economic and patient-centric outcomes into development programs Execute prospective and retrospective studies including database analyses, comparative effectiveness, meta-analyses/systematic reviews, and patient-reported outcomes (PROs), and economic modeling to support the value proposition Follow best practices for HEOR data collection, analysis, modeling, dissemination and publication; ensure the high quality of data collection and analysis Develop economic dossiers and other reimbursement-supportive materials Effectively communicate health economic and outcomes research findings internally and externally Qualification: An advanced degree (e.g., PhD, PharmD, MPH, MS) and an educational focus in the areas of health economics or outcomes research. 3 - 5 years of current experience with health economics and outcomes research within the biotechnology/pharmaceutical industry, in either a consulting or pharmaceutical environment Experiences with large scale observational study design and analyses are preferred Working knowledge of reimbursement and pricing environment, clinical development and commercial activities A track record of success functioning in dynamic, matrix environments with the ability to multitask seamlessly Strong attention to detail and quality focused Exceptional written and verbal communication skills along with the ability to effectively present technical data and complex concepts to diverse audiences 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.