Scholar Rock · 3 months ago
Medical Director, Clinical Research (Early-stage)
Cambridge, MA
Full-time
Onsite
Senior Level
5+ years expScholar Rock is a biopharmaceutical company focused on developing life-changing therapies for serious diseases. The Medical Director will drive clinical development activities for product candidates, providing medical leadership and collaborating with various teams to ensure effective development and oversight of clinical trials.
BiopharmaBiotechnologyMedicalTherapeutics
Responsibilities
Deliver clinical development plan for assigned pipeline products from IND through Proof-of-Concept
Provide medical leadership for clinical development activities of pipeline product candidates, including new indication assessment
Collaborate with other members of the development and preclinical research teams to contribute to building a collaborative culture and improving effectiveness of the development team
Engage with external scientific and clinical trial experts, health authorities, and consultants, to develop scientifically robust development plans
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 early 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
Work within compliance to all applicable GCP/ ICH regulations
Qualification
Required
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
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
Ability to travel domestically and internationally (~15%)
Preferred
neuromuscular or rare disease experience
Company
Scholar Rock
Scholar Rock is a biopharmaceutical company that develops and discovers new medicines and treatments for the serious diseases.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$743MKey Investors
InvusFidelityARCH Venture Partners
2024-10-08Post Ipo Equity· $300M
2023-10-11Post Ipo Equity· $85M
2022-06-17Post Ipo Equity· $205M
Leadership Team
Jay Backstrom
Chief Executive Officer
Recent News
Business Wire
2026-01-12
Morningstar.com
2025-12-13
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