- Salary
- $280k – $420k/yr
- Location
- Cambridge, MA
- Workplace
- Onsite
- Type
- Full-time
- Department
- Development
- Seniority
- Director
- Education
- PhD
- Source
- Lever
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 Sr. Medical Director, Drug Safety & Pharmacovigilance is a key position within the company and safety department, with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise, and guidance, pre- and post-approval for assigned products, the Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will work closely with cross functional teams and Departments for achieving project goals, within timelines & with high quality.
Skills
Risk ManagementCompliance