Pharmacovigilance Scientist

Company Overview

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 approach, the company 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.

In 2025, Stoke entered into a strategic collaboration with Biogen to develop and commercialize zorevunersen for Dravet syndrome; under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada and Mexico while Biogen receives exclusive rights for the rest of the world.
STK-002 is Stoke’s proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. STK-002 has been granted orphan drug designation by the FDA, and a Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.
Stoke’s initial focus is on diseases of the central nervous system and the eye that are caused by a loss of approximately 50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues and systems, supporting broad potential for the company’s proprietary approach.

We are building our Pharmacovigilance department in support of ongoing clinical development activities and NDA submission for a first‑in‑class antisense oligonucleotide (ASO) therapy in a rare pediatric neurological disease. The PV Scientist is a newly created role that offers a genuine opportunity to shape the scientific infrastructure of the PV department at a critical inflection point. The PV Scientist is accountable for overall PV science support for the pharmacovigilance department at Stoke, working with the Safety Physician(s) and cross‑functional teams to lead signal detection activities within the company’s safety governance model.

The ideal candidate will have deep PV science experience and will contribute across clinical and regulatory work streams, playing a key role in further developing and enhancing PV processes and procedures in the post‑approval setting. The position reports to PV Leadership.

• Lead PV Scientist activities of cross‑functional project teams for developmental compounds and/or marketed products at Stoke.
• Collaborate with Safety Physician/PV Leadership to develop, maintain, oversee, and execute comprehensive safety surveillance and signal detection plans for assigned products.
• Support benefit‑risk assessments; author or contribute to signal evaluation reports.
• Author and contribute to safety sections and other relevant content of investigator brochures, protocols, informed consents, and clinical study reports.
• Lead collaboration with PV and clinical representatives; author the reference safety information (RSI) for assigned products based on the benefit‑risk profile.
• Provide strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to processes and timelines.
• Provide strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with PV leadership and other functional experts.

• Bachelor’s degree in life sciences, pharmacy, nursing, or related field; advanced degree (MS, PharmD or equivalent) preferred.
• Minimum of 10 years of proven pharmacovigilance experience, including a combination of PV operations and PV scientist‑related experience.
• Proficiency with signal detection tools and methods; demonstrated ability to synthesize complex safety data into actionable safety intelligence that supports medical judgment of the safety physician and informs benefit‑risk decision‑making.
• Experience with…