VP, Pharmacovigilance and Epidemiology
Safety | South San Francisco, CA | Full Time
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Reporting directly to the Head of R&D/CMO, this leader will be responsible for the Safety of our clinical work. You will work with the Clinical Development team in supporting our efforts in this exciting new area of cancer immunotherapy. This position is based out of our headquarters in South San Francisco, CA.
Responsibilities (include but are not limited to):
- Safety 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
- Pharmacovigilance strategy and implementation
- Aggregate safety reports, including DSURs, Health Authority SAE reporting and other safety aspects of regulatory filings
- Build and lead the safety team, provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
- Identify key areas for change and alignment and mobilize organization to make changes happen
- 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
- Other duties as assigned
Position Requirements & Experience:
- MD or equivalent degree; completion of residency with at least 15 years of industry experience in safety and pharmacovigilance; oncology experience required
- Global experience in clinical trial as well as post-marketing setting
- 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
- 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.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.