Medical Director/Sr Director, Clinical Research (Somerville)

Cambridge, MADevelopment – Clinical Research /Full-Time /On-siteScholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.Summary of Position:The Medical Director, reporting to the VP/SVP, Clinical Research, will be a member of the clinical research team, accountable for driving clinical development activities for assigned product candidates. The successful candidate will be responsible for providing medical leadership for clinical development activities in alignment with corporate strategy. This position requires a highly motivated physician scientist with hands-on expertise in advancing product candidates to deliver life-changing medicines.Position Responsibilities Provide medical leadership for clinical development activities of assigned product candidates, including leading efforts to define clinical development strategy and planCollaborate with other members of the development and research teams to contribute to building a collaborative culture and improving effectiveness of the development teamServe as subject matter expert, leading efforts to provide scientifically robust evaluation of development strategy and plans, including robust literature review to perform disease area assessment, development landscape analysis, and development and regulatory pathway evaluationEngage with external scientific and clinical trial experts, clinical and regulatory consultants, to develop scientifically robust clinical study designProvide hands-on authoring of clinical and regulatory documents, including study concepts, protocols, investigator brochures, regulatory documents, publications, etc.Serve as lead author in clinical responses to regulatory authorities, related to review of protocols, INDs, BLA/MAA/JNDA, and other regulatory filingsProvide 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 safetyResponsible 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 transparencyWork within compliance to all applicable GCP/ ICH regulationsCandidate RequirementsMD, MD/PhD, or equivalent, based in greater BostonAbility to be present regularly in the Cambridge MA officeStrong critical thinking skills, with ability to synthesize complex information, and exceptional communication skills, both verbal and written5+ years of experience in the biopharmaceutical industry, with 3+ years of clinical development experience; neuromuscular or rare disease experience preferred but not requiredHighly organized, outcome-oriented, self-motivated team player with strong interpersonal skills and effective conflict management skillsExperience in innovative clinical study design, analysis of clinical data, publications, and working knowledge of biostatistics and pharmacokinetics/pharmacodynamicsUnderstanding of the drug development process from pre-IND through BLAExperience interacting with health authorities in the US and EUIn-depth knowledge of ICH-GCP and other application regulatory guidelinesAbility to travel domestically and internationally (~15%)Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.