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Stoke Therapeutics · 1 day ago

Medical Director, Neurology Clinical Development

Bedford, Massachusetts, United States

Full-time

Hybrid

Senior Level

$269K/yr - $331K/yr

5+ years exp

Stoke Therapeutics is a biotechnology company dedicated to restoring protein expression through RNA medicine. The Medical Director Neurology Clinical Development will play a key role in planning, executing, and interpreting clinical studies for transformative therapies aimed at life-threatening neurological diseases.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Growth Opportunities

Responsibilities

Support the design, implementation, and oversight of clinical trials in neurology, including protocol development, study conduct, and data analysis

Contribute to the medical and scientific content of key clinical documents (e.g. protocols, investigator brochures, clinical study reports, and regulatory submissions)

Participate in clinical data review, interpretation, and presentation to support timely and informed decision-making

Collaborate with safety/pharmacovigilance on safety review and signal evaluation

Provide medical monitoring and clinical oversight for ongoing studies under the supervision of the Medical Director or Senior Medical Director

Maintain effective collaboration with CROs, investigators, and academic partners to ensure study quality and adherence to timelines

Ensure compliance with GCP, ICH, and all applicable regulatory and ethical guidelines

Support the development of clinical development strategies and study designs in alignment with program objectives and scientific rationale

Contribute to the development, execution, and continuous refinement of global Clinical Development Plans (CDPs)

Integrate emerging data, literature, and competitive intelligence to inform ongoing program decisions and ensure scientific relevance and rigor

Collaborate closely with cross-functional partners including regulatory, clinical development operations, and biostatistics to ensure consistency and accuracy in study execution

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 key opinion leaders (KOLs) and academic investigators to inform study designs and strengthen the scientific foundation of development programs

Represent the clinical development organization at scientific and medical meetings, advisory boards, and key investigator interactions

Contribute to the authorship of abstracts, manuscripts, and scientific presentations that communicate program progress and data to the broader scientific and clinical community

Provide clinical and scientific leadership with cross-functional clinical teams, fostering an environment of accountability, curiosity, and collaborative problem solving

Partner effectively with internal stakeholders across clinical development operations, biostatistics, regulatory, and commercial to ensure scientific and operational excellence in study execution

Serve as a clinical development point of contact in collaborations and partnerships, helping to maintain strong relationships built on scientific integrity, transparency, and shared objectives

Qualification

Clinical development experienceNeurology expertiseFDA/EMA regulations familiarityBoard certification in neurologyClinical trial designData interpretation skillsHigh personal integrityCommunicationOrganizational skillsTeam collaboration