Medical Director, Neurology Clinical Development

Stoke Therapeutics•Bedford, MA

8h•Hybrid

About The Position

Stoke Therapeutics is a biotechnology company focused on restoring protein expression using RNA medicine, specifically antisense oligonucleotides (ASOs). Their pipeline includes zorevunersen for Dravet syndrome (in Phase 3, partnered with Biogen) and STK-002 for autosomal dominant optic atrophy (ADOA) (in Phase 1). They also have early research in Syngap1 with Acadia Pharmaceuticals. Stoke's initial focus is on diseases of the central nervous system and the eye caused by haploinsufficiency, with broader potential demonstrated across other organs and tissues. The Medical Director, Neurology Clinical Development will provide strategic leadership for planning, execution, and interpretation of clinical studies focused on transformative therapies for life-threatening neurological diseases. This individual will be responsible for leading study design and execution and driving interpretation of data to support development decisions across one or more programs. The Medical Director will serve as a key leader within cross-functional teams and as an important representative of the program with investigators, consultants, and other key stakeholders. This role requires an experienced physician-drug developer who can operate with substantial independence, influence program direction, and ensure scientific and medical rigor from early development through late-stage studies. This role will report to the Vice President, Neurology Clinical Development.

Requirements

MD or MD/PhD candidates with relevant clinical development experience in neurology, rare/orphan, or genetic diseases
Minimum 6 years of relevant experience in biotech or pharmaceutical clinical development, including meaningful responsibility for design, conduct, and medical oversight of clinical trials
Strong understanding of FDA/EMA regulations and ICH/GCP guidelines
Strong scientific, analytical, and organizational skills
Demonstrated ability to independently interpret complex clinical and scientific data and translate insights into development decisions
Experience representing programs in cross-functional, partner, and/or regulatory interactions
Strong leadership, communication, and influence skills in a matrixed environment
High personal integrity, sound judgement, and strong commitment to advancing therapies for patients with serious neurological diseases

Nice To Haves

Board certified or eligible in neurology, pediatrics, or a relevant specialty strongly preferred

Responsibilities

Lead the clinical development strategy for assigned neurology programs, aligning study design and execution with overall program goals, target product profile, and regulatory path
Provide medical leadership across the lifecycle of development, from early clinical planning through pivotal studies and submission-enabling activities
Lead the design, review, and finalization of protocols, amendments, and other core clinical documents to ensure scientific rigor, feasibility, and strategic alignment
Drive study-level data review, interpretation, and presentation to support timely and informed decision-making
Identify development risks, anticipate clinical and operational challenges, and proactively propose mitigation strategies
Maintain productive working relationships with CROs, investigators, and study site personnel to support enrollment, data quality, and protocol compliance
Provide medical oversight for ongoing studies, including medical monitoring strategy, safety review, protocol-related decisions, and clinical issue escalation
Partner closely with safety/pharmacovigilance on signal assessment, benefit-risk evaluation, and safety governance
Contribute to the development and refinement of Clinical Development Plans and related program materials
Oversee the quality and consistency of medical input across study teams, vendors, and collaborators
Ensure clinical development activities adherence to GCP, ICH, and applicable regulatory and ethical guidelines
Integrate emerging data, literature, and competitive intelligence to inform ongoing program decisions and ensure scientific relevance and rigor
Participate in internal discussions and presentations to communicate key scientific insights, data interpretations, and development updates
Contribute to the preparation and review of strategic and regulatory documents, including target product profiles, clinical sections of IND/CTA submissions, and briefing packages
Engage and collaborate with investigators, consultants, and key opinion leaders to support trial execution and scientific exchange
Represent the clinical development organization at investigator meetings, advisory boards, and scientific congresses
Contribute to the authorship of abstracts, manuscripts, and scientific presentations communicating clinical findings
Provide clinical and scientific leadership with cross-functional clinical teams, fostering an environment of accountability, curiosity, and collaborative problem solving
Contribute meaningfully to governance discussions and development planning
Provide strategic clinical input into regulatory strategy, submission planning, and lifecycle management activities