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Sr Director, Clinical Development, Neuromuscular (remote)

The Director, Clinical Development is responsible for the design, planning, and medical oversight of clinical studies for all phases of development for neuromuscular programs from early (phase 1) clinical development through regulatory approval. She or he will report into the Chief Medical Officer. The Medical Director, Clinical Development will collaborate with Clinical Operations for study implementation and serve as medical monitor. The Medical Director, Clinical Development will also oversee interpretation and dissemination of study results, including clinical study reports and related publications.

The Director, Clinical Development will serve as a core member of the clinical development team and will contribute to the overall clinical development strategy and ensure all activities occur in compliance with the appropriate regulations. The opportunity includes providing support to translational medicine efforts within our neuromuscular programs, working closely with research to define strategy and grow the discovery pipeline.


  • Provide oversight and leadership of clinical programs including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and SOPs.
  • Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH/GCP, and SOPs.
  • Review clinical data from all phases of development and assist in generating study reports and publications.
  • Serve as study medical monitor, as needed.
  • Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and Principal Investigators.
  • Represent us in interactions with regulatory agencies.
  • Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
  • Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians.
  • Develop and maintain professional relationships with academic and community-based study sites involved in clinical development programs and be accountable for the execution of the translational medicine effort within the company.
  • Collaborate closely with internal research team to integrate translational research into development and clinical strategies.
  • Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and Principal Investigators.
  • Lead internal and external team members, vendors, and consultants to develop an IND package, as well as review and evaluate pre-clinical safety data for regulatory submission.
  • Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports.
  • Organize and present at relevant clinical advisory boards, data monitor committees and medical/scientific meetings.
  • Travel nationally and internationally, as needed.


To thrive on our team, you will need to come with:

  • MD required; preferences for formal training in neuromuscular disease.
  • 3+ years of industry experience.
  • Experience with clinical development in Neurology/Neuromuscular disorders.
  • Strong scientific background.
  • Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
  • Experience with all aspects of management of clinical trials from inception to completion across all phases of development including study design.
  • Experience in communicating/presenting key/complex information to department/functional lead(s)/senior management.
  • Strong knowledge of FDA and ICH regulations.
  • Expert knowledge of Good Clinical Practice (CGP).
  • Ability to multi-task and manage several projects in parallel, paying attention to detail.
  • Ability to forge cross-functional working relationships with internal teams and external project partners.
  • Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation of the trial and resolve the issues in a timely fashion.