Medical Director, Clinical Research (Early-stage)

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at and follow @ScholarRock and on LinkedIn. Summary of Position: The Medical Director, reporting to the VP, Clinical Research, will be a member of the early development team, accountable for driving clinical development activities for product candidates from IND through Proof-of-Concept. The successful candidate will be responsible for providing medical leadership for clinical development activities of follow-on indication(s) for apitegromab as well as new product candidates, 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: * 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 Candidate Requirements: * 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%) $230,000 - $340,000 a year Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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