Medical Director/Sr Director, Clinical Research
Scholar Rock
August 21, 2026
On-site
Cambridge, MA
Clinical Research and Development
Summary of Position:
- The Medical Director (reports to VP/SVP, Clinical Research) will drive clinical development activities for assigned product candidates and provide medical leadership aligned with corporate strategy.
Position Responsibilities:
- Provide medical leadership for clinical development strategy and planning.
- Collaborate cross-functionally to build an effective, collaborative development culture.
- Serve as subject matter expert; lead evaluation of development strategy/plans including literature review, disease area assessment, development landscape, and regulatory pathway evaluation.
- Partner with external scientific/clinical trial experts and consultants to develop robust clinical study design.
- Author/prepare clinical and regulatory documents (e.g., study concepts, protocols, investigator brochures, regulatory documents, publications).
- Lead clinical responses to regulatory authorities for protocols, INDs, BLA/MAA/JNDA, and other filings.
- Provide medical leadership/input in cross-functional activities (business development, non-clinical, QA, clinical operations, biostatistics, regulatory affairs, drug safety).
- Oversee clinical trials, including medical monitoring, adverse event reporting, and patient safety.
- Lead data analysis and interpretation with scientific rigor and transparency.
Candidate Requirements:
- MD, MD/PhD, or equivalent; based in greater Boston.
- Regular presence in the Cambridge, MA office.
- 5+ years biopharmaceutical industry experience, including 3+ years in clinical development (neuromuscular/rare disease preferred).
- Strong critical thinking and exceptional verbal/written communication.
- Experience in innovative clinical study design, clinical data analysis, publications; working knowledge of biostatistics and PK/PD.
- Drug development knowledge from pre-IND through BLA.
- Interaction experience with US/EU health authorities.
- In-depth ICH-GCP and regulatory guideline knowledge.
- Ability to travel (~15%).
- The Medical Director (reports to VP/SVP, Clinical Research) will drive clinical development activities for assigned product candidates and provide medical leadership aligned with corporate strategy.
Position Responsibilities:
- Provide medical leadership for clinical development strategy and planning.
- Collaborate cross-functionally to build an effective, collaborative development culture.
- Serve as subject matter expert; lead evaluation of development strategy/plans including literature review, disease area assessment, development landscape, and regulatory pathway evaluation.
- Partner with external scientific/clinical trial experts and consultants to develop robust clinical study design.
- Author/prepare clinical and regulatory documents (e.g., study concepts, protocols, investigator brochures, regulatory documents, publications).
- Lead clinical responses to regulatory authorities for protocols, INDs, BLA/MAA/JNDA, and other filings.
- Provide medical leadership/input in cross-functional activities (business development, non-clinical, QA, clinical operations, biostatistics, regulatory affairs, drug safety).
- Oversee clinical trials, including medical monitoring, adverse event reporting, and patient safety.
- Lead data analysis and interpretation with scientific rigor and transparency.
Candidate Requirements:
- MD, MD/PhD, or equivalent; based in greater Boston.
- Regular presence in the Cambridge, MA office.
- 5+ years biopharmaceutical industry experience, including 3+ years in clinical development (neuromuscular/rare disease preferred).
- Strong critical thinking and exceptional verbal/written communication.
- Experience in innovative clinical study design, clinical data analysis, publications; working knowledge of biostatistics and PK/PD.
- Drug development knowledge from pre-IND through BLA.
- Interaction experience with US/EU health authorities.
- In-depth ICH-GCP and regulatory guideline knowledge.
- Ability to travel (~15%).