Medical Director, Clinical Research

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 ScholarRock.com 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%)

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.