Scholar Rock is a biopharmaceutical company focused on advancing innovative treatments where protein growth factors are fundamental, aiming to deliver life-changing therapies for serious diseases with high unmet need. The company seeks a Medical Director to provide medical leadership for clinical development activities of product candidates from Proof-of-Concept through marketing approval and lifecycle management.
Requirements
- Experience in innovative clinical study design, analysis of clinical data, publications, and working knowledge of biostatistics and pharmacokinetics/pharmacodynamics
- Understanding of the drug development process from pre-IND through BLA
- Experience interacting with health authorities in the US and EU
- In-depth knowledge of ICH-GCP and other application regulatory guidelines
Responsibilities
- Deliver clinical development plan for pipeline products from Proof-of-Concept through marketing approval and lifecycle management
- Provide medical leadership for clinical development activities of pipeline products
- Drive scientifically robust evaluation of new opportunities, including disease area assessment, landscape analysis, evaluation of development and regulatory pathways, and development of study concepts
- Provide strategic guidance and support to the late-stage development team, including hands-on authoring, for the development of clinical development plans, study protocols, investigator brochures, regulatory documents, publications, etc.
- Provide medical leadership and input in cross-functional team activities, including business development activities, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs and drug safety.
- Responsible for medical oversight of clinical trials, including medical monitoring of studies, adverse event reporting, and patient safety for all clinical trials across a development program.
- Provide medical and scientific leadership in data analysis and interpretation, maintaining integrity, scientific rigor, and transparency
Other
- MD, MD/PhD, or equivalent, based in greater Boston
- Strong critical thinking skills, with ability to synthesize complex information, and exceptional communication skills, both verbal and written
- 5+ years of experience in the biopharmaceutical clinical development function, with 3+ years of clinical development leadership experience; neuromuscular or rare disease experience preferred but not required
- Highly organized, outcome-oriented, self-motivated team player with strong interpersonal skills and effective conflict management skills
- Ability to travel domestically and internationally (~15%)
