The Senior Medical Director, Patient Safety & Pharmacovigilance will provide medical expertise and leadership across the growing Arcus oncology clinical portfolio by supporting a variety of core medical activities including the management of safety signals, risk management, and benefit-risk strategies for the assets. This individual must effectively collaborate cross-functionally at all levels of the organization as well as with external Regulatory Authorities. This leader will report into the Head of Safety and will directly manage Safety physicians and Safety Scientists.
Responsibilities
- Develop, contribute to, and oversee the execution of the signal detection strategy for the Arcus portfolio.
- Preparation and review of periodic aggregate reports (IND Annual Reports, Development Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Report (PBRER), EU renewal, etc.)
- Review, contribute, and author as appropriate relevant sections of the clinical trial protocols, the Investigator’s Brochure (IB), Company Core Data Sheet (CCDS), informed consent form (ICF) and other study specific documents to ensure alignment with the asset benefit-risk profiles.
- Lead the effort to create developmental risk management plans by seeking input from cross-functional stakeholders.
- Provide strategic medical input into Regulatory Authority safety assessments and requests for information.
- Prepare and review relevant sections of the Regulatory Authority filing and submission packets for Investigational New Drug (IND), New Drug Applications (NDAs), Marketing Authorization Applications, etc.
- Participate in and provide input for Drug Monitoring Committees (iDMC), as applicable.
- Contribute to scientific publications (abstracts, posters, papers) for scientific meetings and/or journals.
- Contribute, as appropriate, to the medical safety evaluation of projects for new business development opportunities (e.g., due diligence evaluations).
- Recruit, hire, mentor, and manage direct reports, with responsibility for employee performance evaluations.
Qualifications
- Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) degree required. Academic or hospital setting oncology experience preferred.
- 7+ years relevant Safety Physician experience required; working in oncology with NDA and BLA submissions experience preferred.
- Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within the Safety department.
- Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment.
- Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams.
- Strong working knowledge of global pharmacovigilance requirements and regulations (EMA, FDA, PMDA, Asia-PAC, ICH).
- Strong people and project management experience with the ability to coach and mentor.
- Excellent interpersonal, communication, analytical, and organizational skills.
This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $280,000 - $350,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.
EOE
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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