Sr. Manager/Associate Director of Safety Sciences
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. Manager/Associate Director of Safety Sciences will report to the Director of Safety Sciences and provide scientific, operational, and strategic leadership to support Scholar Rock’s pharmacovigilance (PV) and safety science activities. This individual will contribute to the evaluation, analysis, and management of safety data, ensuring compliance with regulatory standards and internal processes. Tasks include the creation and preparation of Development Safety Update Reports (DSURs), Signal detection presentations, safety board support documentation, and safety sections of investigator’s brochures, informed consent forms, study protocols, and health authority briefing books. The role involves collaboration across functional teams to support the development and safety evaluation of Scholar Rock’s products, particularly in early-stage neuromuscular, oncology, and cardiometabolic disorders. This is a unique opportunity for an enthusiastic and collaborative individual interested in contributing to the development of transformative products for patients with rare diseases. The position is remote-based within the U.S.
Position Responsibilities:
- Support signal management and safety surveillance activities with data from clinical trials and post-marketing sources, including documentation and presentation of summary and findings
- Lead author and/or contributor to the preparation of aggregate safety reports, such as DSURs
- Support clinical development activities such as creation and maintenance of Reference Safety Information (RSI), Risk Management Plans (RMP), core benefit-risk assessments, safety sections of Informed Consent Forms (ICF), study protocols, and Investigators Brochures (IB)
- Prepare and review safety-related section(s) for clinical, regulatory, and scientific documents
- Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting
- Demonstrate knowledge and ensure compliance with current global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), Scholar Rock SOPs and quality standards
- Keep abreast of new PV/safety regulations and guidance from the regulatory authorities
- Develop or contribute to development of PV department processes
- Audit and Health Authority inspection participation as a subject matter expert for PV scientist
Candidate Requirements:
- Bachelor’s degree in a scientific or health-related field (advanced degree preferred, e.g., MSc, PharmD, or PhD)
- At least 5 years of experience in pharmacovigilance, with at least 2 years of experience in safety sciences and signal/risk management within the pharmaceutical or biotechnology industry
- Experience in authoring aggregate safety reports
- Experience in supporting development and maintenance of Investigator Brochures, Reference Safety Information, Study Protocols, and Informed Consent Forms
- Strong understanding of global PV regulations (e.g., FDA, EMA, ICH guidelines) and familiarity with safety-related epidemiology
- Knowledge of clinical drug development processes, including safety governance and risk management activities in both clinical and post-marketing settings
- Demonstrable Patient Safety and/or Clinical/ Drug/Biologic Development experience across a range of activities
- Proficiency in standard office software (e.g., Word, Excel) and safety databases
- Excellent analytical, organizational, and communication skills with the ability to manage multiple priorities in a fast-paced environment
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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