Senior Medical Director, Patient Safety & Pharmacovigilance - Contractor (office or remote)

Description

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 signal, 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.

NOTE: This is a 6 month, 40 hour per week contract role.

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.
• Leads the effort to create developmental risk management plans by seeking input from cross-functional stakeholders.
• Provides 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.

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