Sr. Medical Director, Drug Safety & Pharmacovigilance

Requirements

• MD or MBBS or MD-PhD or equivalent medical degree
• 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
• Strong understanding of pharmacovigilance regulations in the US and EU.
• Experience in supporting drug safety activities in registrational clinical studies
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• Demonstrated skills in scientific analysis and reasoning.
• Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.
• Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable
• Strong track record of delivering results through effective team and peer leadership in matrix
• Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.

Additional Information

Scholar 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 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. 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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