Global Blood Therapeutics

Global Blood Therapeutics San Francisco, CA, USA
May 24, 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
May 23, 2019
Full time
Cost Accounting Manager Position Summary: The Cost Accounting Manager is an integral part of a growing accounting team. The position will be reviewing product costs, associated overheads, manufacturing variances and be a key lead on month-end reporting. The candidate should have a forward-thinking approach to efficient accounting processes, have experience partnering with operations teams, and be able to work independently to drive questions to resolution. As this role will work with teams cross-functionally, an understanding of contract manufacturing and experience working within the manufacturing industry is a requirement. A successful individual should have the ability to effectively multi-task, prioritize work, demonstrate accountability, and meet established deadlines. The ideal candidate will have strong operational experience who enjoys a fast-paced, pre-commercial environment. Essential Duties and Responsibilities: Responsible for analyzing, identify and explain variances to expected product costs, and be responsible for assisting in developing processes and procedures to ensure all general ledger activity is maintained in accordance with GAAP Establish strong partnerships with Supply Chain, Quality Assurance, and Tech Ops team to maintain efficient and scalable processes Prepare accurate, timely cost reports focusing around manufacturing variances, costs of freight, month end accruals, and journal entries in accordance with our established schedule and with input from relevant departments Conduct monthly and quarterly account reconciliations to ensure accurate reporting and ledger maintenance Prepare summarized month end reporting for the senior management team around product costs, month over month and quarter over quarter improvements, and cost drivers Reconcile assigned balance sheet and income statement accounts Comply with Generally Accepted Accounting Principles (GAAP) for financial statements Ensure SOX compliance and ability to remediate non-compliance issues Ensure compliance with all internal processes Perform account reconciliations, month-end and quarter-end activities as it relates to payroll and compensation Perform special projects or other duties as requested Qualifications: Bachelor's Degree in Business, Accounting or Finance Experience working in a publicly-traded, high-growth biotech company preferred Knowledge of cost accounting Able to analyze financial records and interpret for other departments Excellent computer skills; Microsoft Office Suite knowledge, including strong Microsoft Excel and PowerPoint skills Experience in working with accounting software preferably NetSuite (or other Enterprise ERP system) with standard or average costing, bills of material, work in process, and inventory modules A committed team player, detail oriented and an effective communicator Intermediate to advanced knowledge of Excel Excellent verbal, written, 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 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
May 23, 2019
Full time
ASSOCIATE DIRECTOR, CMC ANALYTICAL Position Summary: The Associate Director will be responsible for the analytical activities related to the pipeline product development of small molecule solid oral dosage form. Activities include internal and external method development, method transfer and validation, specifications, reference standard qualification, and analytical /QC testing. 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: Independently manage analytical method development and analytical project timelines Critical review of analytical method transfer documents and release/ stability data package for drug substance and drug product Author and review the analytical technical reports Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings Other responsibilities will include material specifications and change controls Participate in the CMC strategic planning Qualifications: Doctoral degree in chemistry, pharmaceutical sciences, or related discipline, and minimum 10 years of experience, or MS/BS degrees with minimum 15 years of experience in the small molecule pharmaceutical industry Familiar with the current analytical techniques for pharmaceutical development Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices 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
May 21, 2019
Full time
SENIOR SUPPLY CHAIN MANAGER Position Summary: This position will manage activities related to planning and execution necessary to ensure timely and continuous drug supply to patients. This position will support packaging and distribution efforts on the clinical setting and can also support the commercial set up efforts. Serves as a key interface between the Technical Operations and key stakeholders, including Development Teams, Commercial teams, Regulatory Affairs, Finance teams in matters of product supply. Essential duties and Responsibilities: Demand planning and forecasting - able to translate clinical study synopsis/protocols into actionable drug forecasts Supply strategies - develop effective packaging and supply strategies maximizing available inventory by location and shelf life while minimizing waste and potential obsolescence Packaging - oversee clinical packaging activities, coordinate release of drug for clinical use. Support set up of commercial packaging activities Inventory Management - manage global depot inventory supporting clinical studies Label text - develop processes and procedures around label text management. Distribution and Logistics - set up, manage and monitor global distribution networks based on study requirements. Ensure required Import/Export documentation is available Systems - Develop any required Interactive Response Technology (IRT) supply strategies, review and provide input on User Requirement Specifications (URS) and participate on User Acceptance Tests (UAT) as required Participate in Clinical Study Execution (SET) meetings as Supply Chain Subject Matter Expert Effective cross-functional collaborator and communicator. Interface with GBT's CMC team, Regulatory Affairs, Quality Assurance, Clinical Operations groups, and others as required to meet project deliverables Author change controls, deviations, initiate any required GxP documentation as required Procedures - develop and establish Standard Operating Procedures (SOP's) as required Qualifications: BS/BA or MBA degree Vendor management experience, specifically with Clinical and Commercial Packaging vendors Working knowledge of cGXP's, familiar with US, EU regulations applicable to investigational drugs and drug development process Experience with working under GxP systems and authoring change controls, deviations, investigations, and quality related documentation Good organizational and communication skills, effective project and time management skills, and able to meet tight timelines. Excellent interpersonal skills Customer Service oriented, collaborative and self-starter Proficient in Microsoft Outlook, Word & Excel. Excel modeling capabilities a plus Supervisory skills 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
May 19, 2019
Senior Coordinator, Facilities Position Summary: We are seeking an experienced Facilities/Workplace services Senior Coordinator to support our day-to-day operations in a fast pace and rapidly expanding work environment. This individual will support many Facilities services including space planning, vendor services, event planning and security coordination. The ideal candidate is an ambitious self-starter with exceptional communication, time management skills and is a true team player. Essential Duties and Responsibilities: Support a safe and effective working environment with a hospitality mindset and high touch customer service for everyone that comes through our doors Be the initial point-of-contact for all Facilities requests for service through our online ticket system, email or in person request, including delegation and follow up with team members Generate and track department contracts and purchase requests from start to finish and renewals Assist Facilities management with budget development, forecasting and tracking of planned expenditures Track invoices for timely receipt and accrual tracking in partnership with Finance Provide vendor management including scheduling services and tracking to completion Maintain program ensuring valid vendor certificate of insurance (COI) are on file for GBT and property management Manage various Administrative/Facilities special projects and assignments on ad hoc and continuous basis Support security badging needs along with other onboarding/offboarding activities supported by Facilities Work cross-functionally to coordinate personnel moves with IT and end users Participate in safety related programs, including floor monitor and First Aid/CPR/AED training and certification. Support relationship with property management, including the generation and tracking of service requests Monitor the overall appearance, safety and security of our facilities through observation and audits Participate on the EHS/Safety Committee with post meeting follow up and record keeping Primary point of contact for internal/external commuter programs and information updates in intranet and board postings Assist team with managing projects, special events and general tasks Support Reception Desk breaks (beginning in 2020) Qualifications: 2+ years of experience in Workplace/Facilities at a mid-sized company Excellent verbal communications combined with strong written and interpersonal skills Skills in Facilities budget preparation and execution Anticipates and identifies potential problems and collaborates with others on identifying solutions Has solid critical judgment and analytical skills; works well under pressure and able to meet strict deadlines and be highly organized and detail-oriented Strong PC (Word, Outlook, Excel) and keyboarding skills Demonstrated experience managing multiple projects simultaneously Resourceful at information gathering and is self-sufficient Works well independently and collaboratively in a team or group environment Willingness to jump into other department roles to provide support if needed Ability to work overtime, nights and weekends, only if necessary 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
May 17, 2019
Full time
HEAD of DMPK Position Summary : GBT is seeking an exceptional scientist and leader to head our Drug Metabolism and Pharmacokinetics (DMPK) department. Reporting to the Chief Scientific Officer, the successful candidate will develop scientific strategies, lead and mentor a team, and build partnerships cross-functionally to advance GBT's programs. You will be part of an exceptional research team and help advance discovery and development of groundbreaking therapies for serious unmet medical needs. Essential Duties and Responsibilities : Leadership in preclinical and early clinical studies, including but not limited to in vitro and in vivo ADME assays, PK/TK support, M&S Represent the DMPK function in cross functional project teams and provide critical feedback to project teams from a DMPK perspective Manage collaborations with CRO/CMOs for outsourcing activities Ensure reporting timelines for all DMPK related reports. Expected to review, edit, and offer critical feedback on reports generated by CROs Develop and execute scientific strategies to address ADME challenges on discovery and development programs Build and maintain strong collaborative partnerships with Chemistry, Biology, Preclinical Safety, Clinical Pharmacology, CMC and other R&D disciplines to advance GBT programs through discovery and development Implement creative DMPK technologies and approaches to enhance scientific impact and/or efficiencies Ensure completion of necessary DMPK regulatory documentation and reports to support drug development including Investigator Brochures, INDs (or equivalent), and marketing applications Hire, develop, mentor, manage and retain key talent to maintain a high-performing team Participate in assessment of business development opportunities Qualifications: Requires a PhD in pharmacokinetics, pharmacy, pharmaceutical sciences, or related discipline with relevant industrial experience Minimum of 10+ years industrial experience with a demonstrated track record advancing both large and small molecule therapeutics from discovery through registration Extensive team leadership and people management experience in cross functional team setting Expert knowledge of scientific principles and concepts Has established a reputation as a leader in the field with sustained performance and accomplishment PhD or equivalent, with >10 years of experience working in a managerial/leadership or a senior scientific role as part of a multifunctional DMPK group in a pharmaceutical company Deep understanding of the drug discovery and development process and cross-functional dependencies Deep scientific and strategic expertise in various components of predictive and translational DMPK science such as in vitro and in vivo ADME, mass spectrometry and bioanalysis, pharmacokinetic data analysis and interpretation, biotransformation/disposition pathways, drug interaction risk assessment and human pharmacokinetics and dose predictions Successful track record and experience in a DMPK lead role on multiple R&D teams across more than one therapeutic area Strong mentoring and leadership skills, with emphasis on developing and coaching junior scientists to build a high-performing team Ability to stay abreast and critically evaluate scientific literature and new technology as it relates to the discovery and development of new medicines Excellent verbal, written and interpersonal communication skills, and ability to develop and grow strong cross-site/function collaborations 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
May 17, 2019
Full time
EXECUTIVE ASSISTANT, CORPORATE DEVELOPMENT & CORPORATE AFFAIRS Position 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
May 17, 2019
SENIOR ADMINISTRATIVE ASSISTANT - COMMERCIAL Position Summary: Reporting to the Vice President, Commercial Operations and the Vice President, Marketing, the successful candidate will be extremely well organized, an excellent communicator, capable of effectively managing complex schedules, skilled at interfacing with key external audiences, and able to prioritize and work closely with other members of the GBT administrative team to coordinate various activities. Over time, the Senior Administrative 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 Commercial and Marketing teams Support communications within the Commercial and Marketing groups, as well as with internal and external clients Oversee budget tracking and vendor set-up including learning and becoming proficient with Zycus, our contract management and PO system, to ensure paperwork is properly filed and tracked Manage and maintain calendars including the setup and tracking of complicated and logistically challenging meetings Organize, book, and track travel for members of the team as necessary Handle special projects as requested Qualifications: At least eight years of experience in the biopharmaceutical industry, supporting a executive level preferred Highly-developed interpersonal skills including communication and listening skills, attitude, exhibiting a professional, energetic, proactive and enthusiastic demeanor Previous experience supporting a commercial,marketing and sales functional leads Excellent verbal and written skills and attention to detail Ability to handle multiple priorities and manage complicated calendars across multiple executives and external personnel Demonstrated judgment and discretion with confidential company information Demonstrate excellent judgment and influence management skills 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 entrepreneurial environment Proficiency with the following: Microsoft products including PowerPoint, Word, Excel, Outlook, as well as Concur expenses Manage extensive domestic and international meeting and travel arrangements that may often require changes and prepare subsequent final expense reports 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
May 16, 2019
Full time
Managed Care Liaison Position Summary: The Managed Care Liaison (MCL) is responsible for building relationships with and providing advanced scientific and health outcomes support to regional and national managed care organizations, health care systems, government payers, and other organizations that are involved with medication formulary decisions. The MCL also provides field-based representation to facilitate research, education, and other collaborations, in compliance with applicable SOPs. The Managed Care Liaison (MCL) is a field-based medical role that will serve as a strategic partner to the HEOR and Access teams. This role will report to the Vice President, Medical Affairs and will coordinate with the Medical Science Liaison and account management teams. Essential Duties and Responsibilities: Coordinate and deliver scientific, health economic, value, and disease awareness information as presentations or other forms of scientific exchange to regional managed care organizations, pharmacy benefit management companies, health care systems, government payers, and relevant medical and scientific professionals involved with formulary decision making. Communicate key insights to internal colleagues. Identify and develop professional relationships with national and regional managed care organizations and relevant thought leaders. Identify potential outcomes research gaps and assess the health outcomes research capabilities of national and regionally based managed care organizations. Assist in the development of educational managed care programs and tools to help support value and access. Provide reactive presentations to managed care accounts on GBT pipeline and/or other requested scientific information where appropriate. Provide training support to Managed Markets Account leads and other internal stakeholders. Complete all required training, activity documentation, expense reporting, and other administrative responsibilities. Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners. Provide session coverage at relevant scientific and professional meetings . Other duties and responsibilities as assigned. Qualifications: Doctoral degree in a health science related field such as a MD, PhD, or PharmD, with a thorough grasp of the pharmaceutical industry. At least six (6) years of post-doctoral healthcare or related pharmaceutical experience, with majority of the experience in the Pharmacoeconomics, managed care and/or payer environment highly preferred. Ability to effectively communicate complex scientific, technical and clinical information to colleagues and health care decision makers. Proven ability to develop strong relationships with healthcare and/or scientific based professionals as well as with clinical and commercial teams Understanding of managed care, scientific therapeutics, and the application of pharmacoeconomic principals. Proven track record of teamwork, leadership, timely decision making and results orientation in meeting business objectives. Excellent presentation skills. Self-directed and proactive individual with the ability to create opportunities and generate insights to inform strategy. Relevant therapeutic area experience preferred. Travel required (60%). Travel will vary depending upon geography. 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
May 16, 2019
Full time
Senior Coordinator, Facilities Position Summary: We are seeking an experienced Facilities/Workplace services Senior Coordinator to support our day-to-day operations in a fast pace and rapidly expanding work environment. This individual will support many Facilities services including space planning, vendor services, event planning and security coordination. The ideal candidate is an ambitious self-starter with exceptional communication, time management skills and is a true team player. Essential Duties and Responsibilities: Support a safe and effective working environment with a hospitality mindset and high touch customer service for everyone that comes through our doors Be the initial point-of-contact for all Facilities requests for service through our online ticket system, email or in person request, including delegation and follow up with team members Generate and track department contracts and purchase requests from start to finish and renewals Assist Facilities management with budget development, forecasting and tracking of planned expenditures Track invoices for timely receipt and accrual tracking in partnership with Finance Provide vendor management including scheduling services and tracking to completion Maintain program ensuring valid vendor certificate of insurance (COI) are on file for GBT and property management Manage various Administrative/Facilities special projects and assignments on ad hoc and continuous basis Support security badging needs along with other onboarding/offboarding activities supported by Facilities Work cross-functionally to coordinate personnel moves with IT and end users Participate in safety related programs, including floor monitor and First Aid/CPR/AED training and certification. Support relationship with property management, including the generation and tracking of service requests Monitor the overall appearance, safety and security of our facilities through observation and audits Participate on the EHS/Safety Committee with post meeting follow up and record keeping Primary point of contact for internal/external commuter programs and information updates in intranet and board postings Assist team with managing projects, special events and general tasks Support Reception Desk breaks (beginning in 2020) Qualifications: 2+ years of experience in Workplace/Facilities at a mid-sized company Excellent verbal communications combined with strong written and interpersonal skills Skills in Facilities budget preparation and execution Anticipates and identifies potential problems and collaborates with others on identifying solutions Has solid critical judgment and analytical skills; works well under pressure and able to meet strict deadlines and be highly organized and detail-oriented Strong PC (Word, Outlook, Excel) and keyboarding skills Demonstrated experience managing multiple projects simultaneously Resourceful at information gathering and is self-sufficient Works well independently and collaboratively in a team or group environment Willingness to jump into other department roles to provide support if needed Ability to work overtime, nights and weekends, only if necessary 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
May 14, 2019
Full time
SENIOR ADMINISTRATIVE ASSISTANT - COMMERCIAL Position Summary: Reporting to the Vice President, Commercial Operations and the Vice President, Marketing, the successful candidate will be extremely well organized, an excellent communicator, capable of effectively managing complex schedules, skilled at interfacing with key external audiences, and able to prioritize and work closely with other members of the GBT administrative team to coordinate various activities. Over time, the Senior Administrative 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 Commercial and Marketing teams Support communications within the Commercial and Marketing groups, as well as with internal and external clients Oversee budget tracking and vendor set-up including learning and becoming proficient with Zycus, our contract management and PO system, to ensure paperwork is properly filed and tracked Manage and maintain calendars including the setup and tracking of complicated and logistically challenging meetings Organize, book, and track travel for members of the team as necessary Handle special projects as requested Qualifications: At least eight years of experience in the biopharmaceutical industry, supporting a executive level preferred Highly-developed interpersonal skills including communication and listening skills, attitude, exhibiting a professional, energetic, proactive and enthusiastic demeanor Previous experience supporting a commercial,marketing and sales functional leads Excellent verbal and written skills and attention to detail Ability to handle multiple priorities and manage complicated calendars across multiple executives and external personnel Demonstrated judgment and discretion with confidential company information Demonstrate excellent judgment and influence management skills 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 entrepreneurial environment Proficiency with the following: Microsoft products including PowerPoint, Word, Excel, Outlook, as well as Concur expenses Manage extensive domestic and international meeting and travel arrangements that may often require changes and prepare subsequent final expense reports 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
May 14, 2019
Full time
DIRECTOR, CLINICAL PHARMACOLOGY Job Summary: This individual serves as Clinical Pharmacology representative on development teams and provides clinical pharmacology expertise to development projects. The individual will have proficiency in the use of innovative analytical methods to integrate knowledge of pharmacokinetics, biopharmaceutics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs and will work closely with the project team to create clinical development plans that include assessments of a drug's efficacy, safety, commercial viability and fulfillment of registration requirements. He/she will be an individual contributor on projects. Essential Duties and Responsibilities: Represent Clinical Pharmacology on development project teams Partner in the development of clinical pharmacology strategies and the execution of clinical pharmacology studies and exposure-response & population PK/PD analyses Contribute to the development of clinical study concepts and protocols, clinical study reports, and relevant components of regulatory submission documents Review non-clinical as well as clinical pharmacology development plans Assist in the interpretation of preclinical data and extrapolation of implications for human clinical development Responsibility for submitting Clinical Pharmacology sections for review to the Sr. Director, Clinical Pharmacology for regulatory documents Writes support documents for review by Sr. Director, Clinical Pharmacology for responses to regulatory agencies Qualifications: An advanced degree (PhD, or PharmD) in pharmacology, pharmaceutical sciences, pharmacy, life sciences, or other related fields A minimum of 6-10 years relevant experience in the biotech/pharmaceutical industry; minimum of 4 years in small/large molecule clinical pharmacology experience Experience with leading, conducting and analyzing clinical pharmacology/pharmacokinetic studies in humans In-depth understanding of PK/PD, drug metabolism and clinical research concepts Strong theoretical background and hands-on experience interpreting clinical dose-response and PK/PD data to inform clinical study designs and drug development decision-making Proficiency with WinNonlin, or other modeling software Knowledge of regulatory guidance related to clinical pharmacology Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting 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
May 14, 2019
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 San Francisco, CA, USA
May 14, 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
May 13, 2019
Full time
SCIENTIST - PHARMACOLOGY Position Summary: Scientist - Pharmacology to support in vivo studies for preclinical research activities. Essential Duties and Responsibilities: Perform in vivo PK and pharmacology/efficacy studies in a team environment to support early drug discovery projects Establish new disease models to validate novel targets Evaluate the mechanism of action in drug efficacy studies Plan, execute, analyze, and document experiments and present results at internal meetings Attend and present at scientific conferences as applicable Qualifications: PhD degree in biology, or related discipline, with at least 2 years of postdoctoral experience, preferably in industry Hands-on experience performing in vivo studies, dose administration, and tissue sample collection required Experience in surgical models is a plus Sound statistical understanding and knowledge of common statistical software Organized, self-motivated, able to multitask and deliver results with high attention to detail to help drive projects forward in a timely manner Excellent written and verbal communication and presentation 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
May 13, 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
May 12, 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 San Francisco, CA, USA
May 09, 2019
SENIOR SCIENTIST - DMPK Essential Duties and Responsibilities: Oversee ADME and PK studies to support discovery and development programs Assess ADME properties of compounds to support clinical candidate selection and regulatory filing Oversee GLP bioanalysis method development and validation of compound at CRO Coordinate GLP bioanalysis for both clinical and non-clinical PK sample at CRO Work closely with multidisciplinary teams of medicinal chemists, biologists, toxicologists and other scientists to solve project related issues Represent DMPK group in multidisciplinary project teams Present data at internal cross-functional team and department meetings, and external conferences Manage RA or scientist to support the project Qualifications: PhD in Pharmaceutical Sciences or a related discipline 8-10 years of relevant postgraduate experience in DMPK and bioanalytical quantitation in an industrial setting Proficient hands-on experience with analytical instrumentation, particularly LC-MS Expertise in the following areas: pharmacokinetics, biotransformation, and practical experiences conducting in vitro ADME studies such as protein binding, solubility, metabolic stability, etc Ability to work independently and conduct multiple tasks within a fast-paced and team-oriented environment Good oral and written 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
May 08, 2019
Full time
SENIOR MANAGER, OPINION LEADER MARKETING - VOXELOTOR Position Summary: Reporting to the Opinion Leader Marketing Lead, the Senior Manager, Opinion Leader Marketing role will be a critical contributor to the launch of Voxelotor for sickle cell disease. This position will be responsible for the development and execution of opinion leader engagement, advisory board, congress and peer-to-peer activities contributing to the successful launch and overall growth of Voxelotor in the U.S. This role requires strong tactical, operational, organizational, problem solving, communications, and project management skills. This individual must be results oriented and have a sense of urgency to develop and execute strategy and tactics. This professional must have a disciplined approach in taking risks, embraces innovative approaches, and comfortable in an entrepreneurial and growing commercial organization. This individual must also be creative and adaptable to unique and changing situations, be goal-oriented, set aggressive but achievable targets, and motivate internal cross-functional teams. Essential Duties and Responsibilities: Develop and execute the educational strategic and tactical plan for physician education including KOL/speaker identification, speaker bureau development, management, training and slide deck development Lead project management with external vendors including management of operating budget to ensure appropriate investment and execution of brand tactics within cost and timelines while delivering on brand KPIs Partner with cross-functional departments to develop and execute the commercial congress strategy and tactical plan for all national and regional congresses Lead the creation, execution, evolution and maintenance of the commercial KOL engagement plan to cultivate and maintain KOL relationships including strategic identification, development and coordination of HCP interactions Maintain and develop resources for KOL engagement activities such as a database or similar platform for all KOLs Co-lead with medical affairs the planning for KOL engagements at scientific meetings and congresses Liaise and communicate with internal stakeholders, including medical affairs and clinical development to share insights and significant activities, to ensure coordinated engagement for the customer Lead the development and execution of US commercial advisory boards to inform, uncover opportunities and support brand strategy and launch preparation Proactively evaluate/assess the relevant market landscape, monitoring changes in market dynamics, competition, clinician needs and practices Collaborate with Medical, Legal and Regulatory colleagues to ensure an effective and productive promotional review process Develop and track key metrics to measure success, analyze data, and recommend changes based on results Drive internal stakeholder alignment for projects and develop strong relationships with cross-functional teams that support the brand Create and support an environment of inclusion and excellence Operate quickly and decisively in a fast-paced, demanding launch environment Qualifications: Bachelor's degree in marketing, life sciences or related fields. Advanced degree preferred Strong science background preferred with the ability to understand, work with, and provide commercial input to all functions Minimum 5+ years' experience in marketing within the pharma or biotech industry Proven success working in complex specialty markets a plus Experience on new product launch is a plus Ability to interact with customers and KOLs Experience with opinion leader engagement, advisory board, congress and peer-to-peer activities Must demonstrate ability to lead strategically, drive performance, build alignment, inform, negotiate, and collaborate Strong project and process management skills, along with the ability to work on multiple tasks, and to effectively prioritize Strong analytical skills both quantitative and qualitative Strong communication, presentation and interpersonal skills Proven team player with ability to navigate cross functionally 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
May 07, 2019
Full time
MANAGER, QUALITY ASSURANCE OPERATIONS Position Summary: This position is responsible for managing Quality Assurance Operations activities, including batch disposition and QA activities related to manufacturing and testing of drug (API, bulk drug product, packaged/labeled drug product) for phase 1-3 clinical trials, process validation, product launch, and commercial supplies. 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: Required Responsibilities: Document review and batch disposition of API, bulk drug product, and packaged/labeled drug product for commercial and clinical lots (Phase 1-III). Review and approve manufacturing records, including investigations (deviations, out-of-specification/out-of-trend), and analytical data Review and approve contract manufacturing organization (CMO) investigations (deviations, out-of-specification/out-of-trend, complaints). Obtain corrective actions as necessary from CMOs Possible Responsibilities (depending on experience): Review and approve change controls (CMO and internal) associated with the manufacturing and testing of clinical products. Responsible for performing impact assessment related to batch disposition Review and approve test methods, method validation protocols and reports, stability protocols and reports Review and approve (or assist in) SOPs, and specifications (raw materials, regulatory starting materials, in-process, intermediates, finished product, stability) Review and approval of manufacturing process validation protocols and reports Establish (or assist in) and maintain phase-appropriate procedures and processes related to QA Operations, that will effectively support the various phases of drug development (Phases I, II, III) Generate or assist in generation of Annual Product Review Reports Employ the principles of ICH Q8 (Pharmaceutical Development) and Q9 (Risk Management) to the development of manufacturing processes Ensure a systematic approach to development is employed that begins with pre-defined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management Serve as a Subject Matter Expert to support departmental functions and build partnerships and collaborate with stakeholders in other areas of the business to ensure success of the quality operations Must be able to maintain a "big picture" perspective without losing site of the details necessary to meet deliverables and deadlines Support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork As project team member, represent QA on product development teams including pre-clinical, phase 1, 2, and 3 development studies, commercial, and manufacturing improvement teams Interpret Regulatory Authority regulations, guidelines and policies Communicate and ensure compliance with Quality objectives, policies and procedures Qualifications: A BS, MS, or PhD in a scientific related field Minimum 4 years of related experience Experience with batch disposition and review of analytical-related documents (test method and stability protocols and reports) is strongly preferred Ability to make decisions based on phase-specific GMP requirements, and appropriate risk assessment Experience in both small molecule and large molecule pharmaceutical industry in a Quality function is preferred. Knowledge of ICH guidelines related to stability (Q1A-Q1F), Analytical Validation (Q2), and Specifications (Q6A-Q6B) Experience with interacting with domestic and international CMOs and CROs in clinical trial and early commercial stages Strong and clear understanding of cGMPs and pharmaceutical industry best quality practices 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 Excellent verbal, written, interpersonal, organizational, and communication skills are necessary 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.