Sr. Medical Director, Pharmacovigilance

About Stoke:

Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Using Stoke's proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study.

Stoke’s initial focus is diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts.

The Senior Medical Director, Pharmacovigilance will be responsible for the medical review of adverse event data, the development of company causality assessment frameworks in post-marketing surveillance, and leading signal detection and management activities. This individual will work in close partnership with PV operations to build rigorous, scalable medical safety practices suited to a clinical development and complex postmarketing environment. This position will report into the Head of Pharmacovigilance.

This is a role for a physician who is energized by developing business practice frameworks and review processes that a growing medical safety function requires and leading the medical safety domain within the organization. Rare disease carries meaningful responsibility to patient and families with limited therapeutic options, and the ideal candidate is a safety physician for whom that responsibility is a genuine source of motivation.

• Lead medical review of individual case safety reports (ICSR), including serious adverse events (SAE) and adverse events of clinical interest (AECI) across clinical and postmarketing settings; oversee medical review of ICSR performed by vendors/contractors
• Develop and implement a company causality framework for clinical trial and postmarketing AE data
• Build and oversee business practices and review workflows that support consistent and inspection‑ready medical assessment of ICSR
• Oversee appropriate MedDRA coding of postmarketing IC SRs and lead the development of product‑specific coding guidelines

• Lead signal detection and management activities including development/maintenance of product‑specific signal detection plans
• Develop and refine signal detection methodologies appropriate to the postmarketing environment including consideration of data sources, disproportionality analysis
• Prepare and present signal assessments to the Head of PV and applicable safety governance bodies, with clear benefit‑risk contextualization
• Maintain signal tracking and disposition process ensuring signals are documented, evaluated and closed or escalated in accordance with company procedures and regulatory expectations
• Serve as the chair of the cross‑functional, internal safety review committee (ISRC) responsible for analysis of validated safety signals and for development of recommendations on risk classification and risk mitigation actions to the Stoke Executive Safety Committee (ESC)

• Contribute medical safety content to aggregate safety reports (DSUR, PSUR, PBRER) and NDA/MAA safety summaries with particular responsibility for medical narrative sections and clinical interpretation of safety findings
• Provide medical input into Company Core Safety Information and safety content of country‑specific product labeling
• Support regulatory agency interactions on medical safety matters
• Contribute to protocol safety sections, informed consent documents, and investigator brochure safety content
• Contribute to development and maintenance of reference safety information

• Collaborate with the Head of Pharmacovigilance and PV Operational leadership on PV departmental…