Senior Medical Director, Neuromuscular Clinical Development

Scholar Rock, Inc.; Cambridge (MA); Presencial; USD 250 000 - 350 000; Tempo integral

Resumo da oferta

Scholar Rock, Inc. in Cambridge, MA seeks a (Senior) Medical Director reporting to the VP, Clinical Research.

You will provide medical leadership for clinical development activities across the pipeline, ensuring alignment with corporate strategy and delivering life-changing therapies. The role requires a physician-scientist with hands-on experience advancing product candidates, strong collaboration, and ability to interact with health authorities; travel is expected, with regular presence in the

Qualificações

• MD, MD/PhD or equivalent, based in greater Boston.
• Ability to be present regularly in the Cambridge MA office.
• Strong critical thinking and exceptional communication skills.
• 5+ years in biopharmaceuticals with 3+ years in clinical development.
• Experience with study design, data analysis, and PK/PD concepts.
• Understanding of drug development from pre-IND to BLA/MAA and ICH-GCP.

Responsabilidades

• Provide medical leadership for clinical development activities of assigned pipeline products.
• Define clinical development strategy and plan.
• Collaborate to improve development team effectiveness and culture.
• Lead literature reviews and disease area assessments to inform strategy.
• Engage external experts to develop robust study designs.
• Author clinical and regulatory documents (protocols, INDs, BLA/MAA).
• Lead regulatory responses and cross-functional medical input.
• Oversee medical monitoring and patient safety across trials.
• Interpret data with scientific rigor and integrity.
• Ensure compliance with GCP/ICH regulations.

Conhecimentos

Medical leadership

Clinical development

Regulatory understanding

Literature review

Biostatistics

Pharmacokinetics/Pharmacodynamics

Communication skills

Collaboration

Regulatory writing

Formação académica

MD/MD-PhD

Descrição da oferta de emprego

Scholar Rock, Inc. in Cambridge, MA seeks a (Senior) Medical Director reporting to the VP, Clinical Research.

You will provide medical leadership for clinical development activities across the pipeline, ensuring alignment with corporate strategy and delivering life-changing therapies. The role requires a physician-scientist with hands-on experience advancing product candidates, strong collaboration, and ability to interact with health authorities; travel is expected, with regular presence in the