Medical Director, Neurology Clinical Development

Stoke Therapeutics•Bedford, MA

37d•$269,000 - $331,000•Hybrid

About The Position

The Medical Director Neurology Clinical Development will play a key role in the planning, execution, and interpretation of clinical studies focused on transformative therapies for life-threatening neurological diseases. This individual will contribute medical and scientific expertise to advance programs from early development through late-stage studies and regulatory submission. The Medical Director will support cross-functional teams, interface with external partners and investigators, and help ensure the highest standards of scientific and clinical rigor are maintained across all programs. This role will report to the Senior Medical Director in Neurology Clinical Development.

Requirements

MD, MD/PhD candidates with relevant clinical development experience in neurology, rare/orphan, or genetic diseases
Board certified or eligible in neurology, pediatrics, or a relevant specialty (for MDs)
Minimum 5 years’ experience contributing to the design, conduct, or medical oversight of clinical trials including industry experience required
Familiarity with FDA/EMA regulations and ICH/GCP guidelines
Strong scientific, analytical, and organizational skills
Demonstrated ability to interpret complex clinical and scientific data
Excellent communication and presentation skills, with the ability to collaborate effectively across multidisciplinary teams
High personal integrity, scientific rigor, and strong commitment to advancing therapies for patients with serious neurological diseases

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