Medical Director/Sr Director, Clinical Research

Scholar Rock; Cambridge (MA); On-site; USD 200,000 - 335,000; Full time

Job summary

A leading biopharmaceutical company in Cambridge, MA, is seeking a Medical Director/Senior Director to lead clinical development activities. The successful candidate will provide medical leadership, collaborating with cross-functional teams to ensure robust clinical plans for product candidates. Candidates should hold an MD/PhD, have a minimum of 5 years in biopharmaceutical development, and possess strong communication and critical thinking skills. The role involves overseeing clinical trials ensuring compliance and patient safety, with a competitive salary range of $200,000 - $335,000 annually.

Qualifications

• 5+ years in biopharmaceutical clinical development.
• 3+ years in clinical development leadership.
• Experience in innovative clinical study design.

Responsibilities

• Deliver clinical development plans for pipeline products.
• Provide medical leadership for development activities.
• Engage with scientific and clinical trial experts.

Skills

Critical thinking

Communication skills

Team collaboration

Conflict management

Education

MD or MD/PhD

Job description

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/Senior Director, reporting to the SVP, Clinical Research, will be a member of the late‑stage development team, accountable for driving clinical development activities for product candidates from Proof‑of‑Concept through marketing approval and lifecycle management. The successful candidate will be responsible for providing medical leadership for clinical development activities for apitegromab as well as other product candidates entering late‑stage development, in alignment with corporate strategy. This position requires a highly motivated physician scientist with hands‑on expertise in advancing late‑stage product candidates to deliver life‑changing medicines.

Position 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 assigned pipeline products
• 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
• Provide strategic guidance and support to the late‑stage development team, including hands‑on authoring, 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 with ability to be present regularly in the Cambridge, MA office
• 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%)

$200,000 - $335,000 a year

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