Associate Medical Director, Neurology Clinical Development

Stoke TherapeuticsBedford, MA
Hybrid

About The Position

The Associate Medical Director, Neurology Clinical Development will contribute to the planning, execution, and interpretation of clinical studies for transformative therapies targeting life-threatening neurological diseases. This individual will provide medical and scientific to support one or more studies and play a hands-on role in study conduct, data review, and cross-functional clinical development activities. The Associate Medical Director will work closely with and will report to the Senior Medical Director to help translate program strategy into high-quality clinical execution. This role is well suited for an individual who has strong foundational knowledge in clinical development and is ready to take on increasing responsibility in clinical document development, medical monitoring, supporting cross-functional teams, and interfacing with external partners and investigators to help ensure the highest standards of scientific and clinical rigor are maintained across the programs.

Requirements

  • MD, MD/PhD, or PharmD 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 3 years of relevant experience in clinical research, clinical development, or medical monitoring; biotech/pharmaceutical experience strongly preferred
  • Experience supporting the conduct or medical oversight of interventional clinical trials
  • Working knowledge of FDA/EMA regulations and ICH/GCP guidelines
  • Strong scientific, analytical, and organizational skills, with careful attention to detail
  • Ability to interpret complex clinical and scientific data and communicate findings clearly
  • Effective collaborator who works well in a matrixed environment
  • High personal integrity, sound judgment, and strong commitment to advancing therapies for patients with serious neurological diseases

Responsibilities

  • Contribute to the design, implementation, and oversight of clinical trials in neurology, including protocol development, study conduct, and data analysis
  • Serve as a study-level medical monitor for assigned trials, with oversight from the Senior Medical Director
  • Participate in ongoing medical review of eligibility, protocol deviations, and clinical data trends to support quality study conduct
  • Draft and review key clinical documents (e.g. protocols, investigator brochures, clinical study reports, informed consent forms, medical monitoring plans, and sections of regulatory submissions)
  • Collaborate with safety/pharmacovigilance on case review and signal evaluation
  • Work closely with clinical development operations, data management, biostatistics, and regulatory colleagues to support study execution and timely delivery of milestones
  • Maintain productive working relationships with CROs, investigators, and study site personnel to support enrollment, data quality, and protocol compliance
  • Ensure adherence to GCP, ICH, and applicable regulatory and ethical requirements
  • Contribute clinical and scientific insight to study design discussions and broader program activities
  • Review emerging clinical data, literature, and competitive intelligence to help inform study conduct and development decisions
  • Support preparation of data summaries, internal presentations, and study-level recommendations for cross-functional review
  • Contribute to the development and refinement of Clinical Development Plans and related program materials
  • Assist in the preparation of regulatory documents, briefing packages, and health authority responses
  • Interact with investigators, consultants, and key opinion leaders to support trial execution and scientific exchange
  • Participate in investigator meetings, advisory board, and scientific congresses
  • Contribute to the authorship of abstracts, manuscripts, and scientific presentations communicating clinical findings
  • Operate as a strong cross-functional partner with a willingness to learn, adapt, and take on increasing scope
  • Enhance clinical development judgment through active participation in study-team discussions and decision-making forums
  • Contribute to a collaborative, scientifically rigorous team environment focused on patients and execution excellence

Benefits

  • medical, dental and vision insurance
  • life, long and short-term disability insurance
  • paid parental leave
  • a 401K plan with company match
  • unlimited vacation time
  • tuition assistance
  • participation in our Employee Stock Purchase Program (ESPP)
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