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, 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 on LinkedIn.
Summary of Position:
Here is your opportunity to join a patient-inspired, creative, collaborative and experienced team. Playing a critical role within Scholar Rock, the Medical Director, Safety & Pharmacovigilance will be responsible for strategic medical leadership for global pharmacovigilance and risk management activities for Scholar Rock developmental candidates. This position requires a highly motivated and enthusiastic medical professional with hands-on expertise in taking novel compounds from clinical candidate nomination through proof-of-concept and beyond. Key success factors for the position include rare disease, cardiometabolic disease or immuno-oncology drug development experience, creativity, integrity in thought and action, team-centric mindset, integrative thinking, ability to influence decision-making, exceptional communication skills, the ability to inspire, and being a “hands-on doer.”
Position Responsibilities:
- Leads and directs all aspects of pharmacovigilance activities for assigned investigational products including signal detection, analysis, communication, and mitigation of potential safety risks.
- Provides medical and pharmacovigilance expertise to lead decision making based on ongoing benefit-risk assessment, pharmacoepidemiologic or clinical trial data interpretation, and risk evaluation and mitigation.
- Authors, reviews, and provides input for drug-safety related regulatory reports and clinical study documents including periodic aggregate reports, case series analyses, and regulatory submission documents.
- Contributes to the development of internal processes including SOPs, Policies and Work Instructions.
- Willingly supports other activities as needed.
Candidate Requirements:
- MD required, combined with 5 to 10 years of experience in pharmacovigilance and clinical safety.
- Clinical experience with patients following post-graduate training is an asset.
- Knowledge of principles of epidemiology and statistics.
- Critical thinking, analytical skills and ability to make high-level decisions.
- Proven history of successful involvement in Regulatory submissions, IND and/or BLA/NDA.
- History of successful interactions with regulatory authorities, IRBs/Ethics Committees, medical community, knowledge of regulatory requirements for biologics.
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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