Senior Medical Director, Clinical Development (Neurology / Neuromuscular)


Boston
Permanent
Negotiable
Clinical
PR/587709_1786392175
Senior Medical Director, Clinical Development (Neurology / Neuromuscular)

Senior Medical Director, Clinical Development (Neurology / Neuromuscular)

Location: Greater Boston (Hybrid, 3 days onsite)

About the Opportunity

We're partnering with a well-capitalized, clinical-stage biotech that is building one of the more differentiated pipelines in rare neuromuscular and neurodegenerative disease, anchored by a validated biological platform with genuine multi-indication potential. Recent non-dilutive capital from a major pharma partnership has de-risked the balance sheet and sharpened focus on the neuromuscular portfolio, including programs advancing toward key clinical readouts in muscular dystrophies and ALS.

This is a development leadership seat, not an execution seat. You'll own the clinical strategy for one or more assets and help shape how these therapies reach patients, working alongside a scientific leadership team that people actually want to work for.

The Role

As the Senior Medical Director, you will serve as a core medical leader across one or more clinical programs in neurology / neuromuscular disease. This is a hands-on, highly collaborative role owning the development plan for one or more assets and shaping how these therapies are built and brought to patients, working alongside cross-functional teams spanning Clinical Sciences, Clinical Operations, Biostatistics, Safety, Regulatory, and Clinical Pharmacology.

Key Responsibilities

  • Serve as Clinical Development Leader and represent Clinical Development on program and project strategy teams.
  • Build and drive the Clinical Development Plan for one or more indications, from strategy through global regulatory approval and market access.
  • Lead the design of scientifically rigorous clinical protocols aligned to the development plan.
  • Author and lead the clinical sections of key documents (protocols, Investigator's Brochures, CSRs, INDs/CTAs, NDAs/MAAs, and regulatory responses).
  • Oversee the Medical Monitor(s) and partner with the Head of Safety on continuous benefit/risk evaluation, safety monitoring, and signal detection.
  • Partner with Biostatistics and Clinical Sciences on data analyses and presentations for safety committees, regulatory submissions, and internal reviews.
  • Represent the company externally with KOLs, investigators, regulatory authorities, data monitoring committees, advisory boards, and patient advocacy groups.
  • Collaborate with Medical Affairs on scientific communication, publication planning, and congress activity.

What we're looking for

  • MD (or equivalent). Board certification in Neurology is a strong plus.
  • 5+ years of clinical development experience in biotech or pharma, with a track record as a development leader on cross-functional teams.
  • Command of clinical trial design, global regulatory strategy, and end-to-end drug development.
  • Direct experience in neuromuscular, neurology, or rare disease is highly valued; ALS, DMD, or similar indications a real plus.
  • Strong analytical and communication skills, and the kind of person who thrives in a lean, fast-moving environment where you wear multiple hats and your work is visible.
  • Able to work a hybrid schedule (3 days onsite) with up to ~20% travel.

Why apply

You get real ownership over strategy at a company with the science, the capital, and the momentum to matter, at exactly the inflection point where the decisions you make shape the outcome.

FAQs

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