Senior Medical Director - Neuromuscular Clinical Development

Scholar-Rock

Cambridge (MA)

On-site

USD 250,000 - 350,000

Full time

10 days ago
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Job summary

Scholar Rock in Cambridge, MA is seeking a (Senior) Medical Director to lead clinical development for assigned programs. Reporting to the VP, Clinical Research, the role provides medical leadership to advance product candidates and deliver life-changing medicines.

The candidate will author clinical and regulatory documents and interact with health authorities. The ideal candidate is an MD/MD-PhD with 5+ years in biopharma and 3+ years in clinical development, with neuromuscular or rare disease

Qualifications

  • MD, MD/PhD or equivalent required.
  • Based in greater Boston with regular presence in Cambridge, MA.
  • Strong communication and critical thinking skills; excellent interpersonal abilities.
  • 5+ years in biopharma with 3+ years in clinical development; neuromuscular or rare disease experience preferred.
  • Experience with study design, data analysis, publications, and PK/PD concepts.
  • Knowledge of ICH-GCP and regulatory guidelines; travel ~15%.

Responsibilities

  • Provide medical leadership for clinical development strategy and plans.
  • Lead cross-functional teams and collaborate with development and research groups.
  • Prepare clinical and regulatory documents and author sections for regulatory filings.
  • Serve as lead author in responses to regulatory authorities (INDs, BLA/MAA/JNDA).
  • Oversee safety monitoring, data interpretation, and regulatory compliance.
  • Engage with external experts and authorities to shape study designs.

Skills

Communication skills
Critical thinking
Interpersonal skills
Biostatistics knowledge
PK/PD knowledge
Team collaboration

Education

MD or MD/PhD or equivalent

Job description

Scholar Rock in Cambridge, MA is seeking a (Senior) Medical Director to lead clinical development for assigned programs. Reporting to the VP, Clinical Research, the role provides medical leadership to advance product candidates and deliver life-changing medicines.

The candidate will author clinical and regulatory documents and interact with health authorities. The ideal candidate is an MD/MD-PhD with 5+ years in biopharma and 3+ years in clinical development, with neuromuscular or rare disease

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