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Senior Medical Director of Drug Safety & Pharmacovigilance

Scholar Rock, Inc.Cambridge, MA
On-site Full-time

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Experience Level

Senior

Qualifications

MD, PhD, or equivalent medical degree. Minimum of 10 years of experience in drug safety and pharmacovigilance within the biopharmaceutical industry. Proven track record of leadership and strategic influence in safety management. Strong understanding of global regulatory requirements and risk management principles. Excellent communication and interpersonal skills, with the ability to collaborate effectively across diverse teams. Experience with neuromuscular and oncological products is a plus.

About the job

Scholar Rock, Inc. is a pioneering biopharmaceutical firm dedicated to the discovery, development, and delivery of transformative therapies for individuals suffering from serious diseases with significant unmet medical needs. As a recognized leader in the biology of the transforming growth factor beta (TGFβ) superfamily of proteins, Scholar Rock is committed to advancing innovative treatments where the modulation of protein growth factors is crucial. Over the last decade, we have developed a robust pipeline aimed at redefining the standard of care for neuromuscular conditions, cardiometabolic disorders, cancer, and other diseases where growth factor-targeted therapies can radically change patient outcomes.
 
Scholar Rock is the first and only company to demonstrate clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). Our commitment to unlocking unique therapeutic strategies is driven by our proprietary platform, which has generated novel monoclonal antibodies designed to modulate protein growth factors with remarkable precision. By leveraging cutting-edge scientific advancements in therapeutic areas that have historically been overlooked by conventional treatments, Scholar Rock tirelessly works to create new avenues for patient care. Discover more about our innovative approach at ScholarRock.com and follow us on @ScholarRock and LinkedIn.

Position Overview:

The Senior Medical Director of Drug Safety & Pharmacovigilance plays a critical role within the company, significantly influencing the development and lifecycle management of drug projects. This position is responsible for defining and implementing safety strategies and providing expert guidance during both pre- and post-approval phases for assigned products. The Senior Medical Director will proactively lead risk management initiatives in compliance with global regulatory standards, continuously evaluating safety data, conducting signal detection, and managing the safety profiles of compounds. Additionally, this role will involve close collaboration with cross-functional teams to achieve project objectives within established timelines and quality standards.

About Scholar Rock, Inc.

Scholar Rock, Inc. is a leading biopharmaceutical company focused on transforming patient care through innovative therapies for serious diseases. With a strong commitment to scientific advancement and patient outcomes, Scholar Rock is pioneering new approaches to treatment, particularly in under-addressed therapeutic areas.

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