Medical Director - Pharmacovigilance

5w1 month ago

Apogee Therapeutics

Remote · Full-time · $285,000 – $330,000

About this role

Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics for inflammatory and immunology markets. We are seeking a Medical Director of Pharmacovigilance to join the Clinical Development team in a newly created position.

In this role, you will oversee safety aspects across Apogee's pipeline, supporting regulatory approvals and patient safety. You will identify emerging safety signals and ensure appropriate escalation through internal governance pathways.

You will collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, and Medical Writing. The role also involves leading preparation of DSURs, Investigator's Brochures, and safety sections of protocols.

This position offers the chance to work in a fast-paced, highly dynamic environment at a well-funded Nasdaq-listed company. You will actively contribute to shaping a culture founded on C.O.R.E. values: Caring, Original, Resilient, and Egoless.

Requirements

MD degree required.
Strong expertise in pharmacovigilance and drug safety across clinical development stages.
Experience with signal detection, risk management, and safety governance processes.
Familiarity with global regulatory requirements for safety reporting and submissions (e.g., DSUR, IB, IND, NDA).
Proven ability to collaborate cross-functionally with Clinical Development, Regulatory Affairs, and other teams.
Ability to prepare and review high-quality safety narratives and MedDRA coding.
Experience providing safety input into ISS and NDA/BLA/MAA submissions.

Responsibilities

Identify emerging safety signals and ensure appropriate escalation through internal safety governance pathways.
Contribute to the development and execution of pharmacovigilance strategies for Apogee clinical programs across various stages of development.
Maintain ongoing benefit–risk assessments incorporating disease severity, unmet medical need, and emerging clinical data.
Collaborate with Regulatory Affairs to develop responses to safety-related regulatory agency inquiries.
Lead preparation and review of DSURs, Investigator’s Brochures, safety sections of protocols, informed consent forms, and clinical study reports.
Provide safety input to regulatory submissions (INDs/CTAs), protocol amendments, and responses to health authority inquiries.
Support the development of the Integrated Summary of Safety and safety-related components of NDA/BLA/MAA submissions.
Review safety content of scientific publications such as posters, abstracts, and manuscripts.

Benefits

Work in a fast-paced, highly dynamic environment at a well-funded Nasdaq-listed company.
Opportunity to actively contribute to shaping the company culture and grow professionally.
Culture founded on C.O.R.E. values: Caring, Original, Resilient, and Egoless.