Director/Sr. Director of PV Sciences
Cambridge, MA
Development – PV /
Full-Time /
Hybrid
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:
Scholar Rock is looking for a Director/Sr. Director-level Pharmacovigilance Scientist to lead all aspects of patient safety & risk management activities pre- and post-approval, including signal detection & management, aggregate safety report (DSUR, PSUR/PBRER/PADER) planning and development, product-level risk management activities and key safety activities, including safety governance meetings, regulatory submissions and support during audits/inspections. Key additional responsibilities include oversight of the PV Scientist group, providing strategic leadership for Medical Safety Science-related activities, represent Drug Safety and PV and Medical Safety Science on cross-functional teams, and representing the Head of Drug Safety and PV as directed.
Position Responsibilities:
- Lead safety evaluation and benefit-risk strategies for assigned products and programs, across the product life-cycle
- Oversee and support other PV scientist team members in risk management activities, including signal management, safety governance meetings, preparation of aggregate safety reports and other clinical trial (e.g., protocols, Investigator brochures, informed consent/assent forms) and/or post-marketing activities
- Prepare and review safety-related section(s) for clinical, regulatory, and scientific documents, including IND, NDA/BLA, ad-hoc activities
- Support BLA/MAA submission activities through peri-approval process, including authoring and management of US PV Plan, EU Risk Management Plan, support safety labelling activities
- Support responses to Health Authority safety queries, as applicable
- Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting
- Lead and/ or contribute to the creation and maintenance of Reference Safety Information
- 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 e.g., Signal detection, Risk Management Plan, Aggregate Safety reports, Safety governance
- Health Authority inspection participation as a subject matter expert as a PV scientist
- Support implementation of the Global PV System, including supporting the QPPV and local PV representatives in matter of risk management, as applicable
- Actively participates in PV leadership team in planning and execution of key Departmental and Company goals and objectives
Candidate Requirements:
- MSc or PhD or professional qualification in a health science field (e.g., nursing or pharmacy) with working knowledge on a relevant scientific/technical discipline (e.g., oncology, metabolic diseases, rare diseases etc.) with demonstrated experience with the responsibilities, deliverables, and skills
- At least 7 years of drug safety and risk management experience within the pharmaceutical, biotech or CRO industry
- Broad clinical drug development Safety Surveillance experience, across all phases of development
- Experience in leading safety/scientific activities on MAA/BLA submissions
- Experience Developmental core safety information creation and updates
- Authoring of Periodic Safety Reports
- Development of Reference Safety Information/Investigators Brochure, Patient Informed Consents
- Authoring Risk Management Plans
- Exposure to Senior Safety Governance Board interactions
- Demonstrable Patient Safety and/or Clinical/ Drug/Biologic Development experience across a range of activities
- Strong working knowledge of PV regulations
- Good understanding of safety-related epidemiology preferred
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
