Medical Director Jobs

The role:

Agenus and MiNK are searching for a collaborative, resourceful, and innovative Safety Physician to act as a safety expert for the clinical portfolio, accountable for the safety strategy, and major safety deliverables for each product. This includes representing Safety on the cross-functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders. This role will also collaborate with the PV Science organization to manage the benefit-risk profile of the Agenus/MiNK clinical products.

In the role you will:

• Analyze and interpret data from various sources including non-clinical, clinical, and scientific literature.
• Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Biometrics, and Legal.
• Participate in and provide input for internal Drug Monitoring Committees (iDMCs).
• Conduct signal detection, monitoring, evaluation, interpretation and management of products in conjunction with the product assigned PV Scientist.
• Review, contribute, and author as appropriate, relevant sections of the clinical trial protocols, the Investigator’s Brochure (IB), Company Core Data Sheet (CCDS), and other study specific documents to ensure alignment with the asset product benefit-risk profiles.
• Contribute to relevant sections of the DSUR and own the overall strategy of the risk language for each product.
• Author and contribute to SOPs, WIs, and corporate policies to maintain a state of inspection readiness.
• Prepare and review relevant sections of the Regulatory Authority filing and submission packets for Investigational New Drug (IND), New Drug Applications (NDAs), Biologics License Applications (BLAs), and Market Authorization Applications (MAAs).
• Provide strategic medical input, and author as appropriate, Regulatory Authority safety assessments and requests for information.

Qualifications: About You

• Sound strategic evaluation, analysis, and decision-making skills.
• Experience in clinical stage oncology is preferred.
• Excellent verbal, written, and organizational skills with proven success in leading and collaborating with cross-functional teams.
• Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.) degree required.
• Ability to work effectively in a dynamic, complex, and fast-paced team environment.
• 4+ years relevant Safety and Pharmacovigilance experience required.
• Demonstrated knowledge of the FDA, EMA, ICH guidelines, and other global institution regulations.