Vice President of Safety and Pharmacovigilance

2 weeks ago

South San Francisco, California, United States Allogene Therapeutics Full time
About Allogene Therapeutics

Allogene Therapeutics is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Our mission is to deliver readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

Job Summary

We are seeking a highly experienced and skilled Vice President, Head of Safety and Pharmacovigilance to lead our safety team and ensure the performance of employees is proactively managed and they are coached, trained and developed in order to maximize their contribution. The successful candidate will serve as the in-house drug safety and pharmacovigilance subject matter expert for product candidates and oversee clinical trial safety, including safety monitoring plan and data analysis.

Key Responsibilities
  • Leadership of the safety team, providing necessary training and ongoing coaching and recognition of direct staff, including performing annual performance reviews
  • Ensure the performance of employees is proactively managed and they are coached, trained and developed in order to maximize their contribution
  • Serve as the in-house drug safety and pharmacovigilance subject matter expert for product candidates
  • Oversight of clinical trial safety, including safety monitoring plan and data analysis
  • Assess emerging safety data, ensure appropriate risk communication, and development of risk management/minimization strategies
  • Cross-functional leadership in managing interactions with Health Agencies around product candidate safety
  • Leadership of Safety Review Committee meetings and participation in DSMB meetings as appropriate
  • Pharmacovigilance strategy and implementation
  • Oversight of authorship of aggregate safety reports, including DSURs, Health Authority SAE reporting, Investigators' Brochures and other safety aspects of regulatory filings
  • Oversight of safety vendors
  • Identification and communication around opportunities for change and alignment and leadership toward change when necessary
  • Influence and/or develop broad-based programs and initiatives to meet executive level vision and mission
  • Collaborate with functional leaders to set strategy and shared objectives
  • Accomplish results through the management of a team of managers, professional employees and/or other leaders as well as individual contributors
  • Represent Allogene as the Safety representative at meetings with regulatory authorities and third parties such as licensing or co-development partners, consultants, etc.
Requirements and Experience
  • MD or equivalent degree; completion of residency with industry experience in safety and pharmacovigilance; oncology and/or autoimmune development experience required; cell therapy experience is additionally desirable
  • Global experience in clinical trial as well as post-marketing setting (oncology/cell therapy experience highly preferred but not required)
  • Experience with global regulatory filings
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
  • Ability to communicate with internal and external physicians to evaluate specific safety events
  • Strong knowledge and understanding of US, EU and Asian pharmacovigilance regulatory requirements and general regulatory expectations
  • Ability to evaluate CROs and other vendors that may assist Allogene in fulfilling safety oversight and reporting obligations
  • Candidates must be authorized to work in the U.S
About Allogene Therapeutics

Allogene Therapeutics is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Our mission is to deliver readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

We are committed to a diverse workforce and welcome diversity of opinions and thought. We offer a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off, and much more.

The expected salary range for this role is $320,000 to $380,000. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

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