Vice President, Safety (Pharmacovigilance)

Location
San Francisco, CA, United States
Posted
Aug 29, 2020
Ref
861
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
VICE PRESIDENT, SAFETY (PHARMACOVIGILANCE)

Position Summary:

Global Blood Therapeutics is seeking a seasoned leader to provides strategical and operational leadership to build, scale and lead the Safety Department, which includes risk management, safety operations, and safety compliance. The incumbent is responsible for ensuring that GBT has an industry-leading approach to global risk management, which includes signal detection and evaluation resulting in an overall benefit-risk assessment, for both investigational and marketed molecules. This person ensures that the department has the necessary internal expertise in the above domains, and thoughtfully mentors everyone in the department. The person is an active member of the development leadership team (DLT) and must ensure that program development teams (PDTs) and clinical study teams (CSTs) are appropriately staffed and supported. Key relationships include, but are not limited to, partnership with the program team leaders (PTLs) and the medical affairs department. This person interacts with the R&D Committee, as needed, chairs the Drug Safety Committee, and reports to the Chief Medical Officer (CMO).

Essential Duties and Responsibilities:

  • Recruits and develops colleagues in the safety department; maintain a positive atmosphere (climate), consistent with GBT values; ensures the department is appropriately sized today and is scalable; achieves clarity for roles and decision-making; encourages the department to be creative, learn, and define precedent in safety strategy and execution; committed to colleague development, taking into account the individual's professional goals; provides timely, transparent and respectful feedback
  • Accountable for innovative safety strategy across all molecules (investigational and marketed) at the program level; clearly defines the requirements for effective signal detection, evaluation and proactive benefit-risk assessment. Implements risk mitigation strategies, as needed. Ensures that safety operations and safety compliance meet the requirements of global health authorities, which includes but is not limited to, generation and management of a pharmacovigilance master file, selection and management of QPPV (qualified person responsible for pharmacovigilance), authorship and maintenance of safety related SOPs, guidelines, and work instructions
  • Prioritizes allocation of safety resources and headcount
  • Chairs Product Safety Committee
  • Is the primary reviewer of the safety elements of key deliverables: target product profiles, product development plans, protocols, case report forms, clinical study reports, congress abstracts / posters, publications, and regulatory submissions (INDs, briefing packages, meeting requests, NDA / BLAs, product labeling, annual reports)
  • Fosters expertise: encourages safety colleagues assigned to a molecule (at the study or program level) are the in-house safety experts on their molecule and versed in the latest trends in all aspects of safety
  • Participate, as needed, with global health authority interactions to address potential safety issues
  • Oversees the selection and management of safety-related vendors to ensure deliverables are within budget and quality specifications
  • Be an effective peer to the members of the DLT (heads of regulatory affairs, biometrics, clinical operations, clinical science ) to collectively build a best-in-class development organization; contributes to the R&D committee, as needed
  • Ensure the product development teams and clinical study teams are appropriately staffed with colleagues at the right level; fosters and models appropriate safety decision-making at the right venue (CST, PDT, R&D committee, SMT)
  • Ensure timely and useful safety consultation across GBT - either directly or by appointing the appropriate delegate

Qualifications:
  • M.D. with board certification or eligibility preferred
  • A proven leader with at least 15 years of global safety experience in large and small biopharmaceutical companies
  • At least seven years of management experience; responsible for safety evaluation of multiple molecules (investigational and marketed); has therefore managed a team of safety physicians and safety scientists at the director and manager levels; has effectively scaled prior safety departments
  • Can provide examples of managing multiple, often complex and sometimes competing, priorities to effective and efficient conclusion; comfortable with ambiguity, being agile, and fostering disciplined decision-making
  • Can point to a track record of innovation in safety, as it applies to proactive signal detection and evaluation, benefit-risk assessment, risk mitigation, safety operations and compliance
  • Represented safety with external stakeholders (e.g., steering committee, investigators, health authorities); negotiated, as needed, with safety vendors and consistently held them accountable to agreed to deliverables

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.