Scholar Rock · 1 month ago
Director/Sr. Director of Pharmacoepidemiology
Cambridge, MA
Full-time
Onsite
Director/Executive
$190K/yr - $330K/yr
10+ years expScholar Rock is a biopharmaceutical company focused on developing life-changing therapies for serious diseases. They are seeking a Director/Senior Director of Pharmacoepidemiology to oversee the development and execution of observational studies and regulatory documents, serving as a key subject matter expert in safety.
BiopharmaBiotechnologyMedicalTherapeutics
Responsibilities
Designs, produces and oversees protocols for observational studies using secondary data or primary data collection, including Company-sponsored or other data sources
Oversee timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide (e.g., Risk Management Plan, orphan or breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing documents
Contributes to Risk Management Plans (RMP, PV Plans etc) for products throughout lifecycle
Performs systematic epidemiologic literature reviews and summaries for relevant safety topics
Performs signal detection analyses of safety reporting system databases (AERS, Vigibase) using data mining software
Actively participates including making presentations at meetings including product safety team and Global Patient Safety staff meetings
May supervise 3rd parties e.g., vendors or contract/other staff
Supports PV System implementation and maintenance and other Departmental goals and objectives
Qualification
Required
Doctoral degree e.g., PhD or Master's degree in Epidemiology from an accredited institution
Minimum of 10 years relevant work experience, preferentially in the Pharmaceutical/Biotechnology industry with a primary focus on epidemiology evidence generation, especially for clinical development support, regulatory submissions and safety
Solid knowledge of study methodology in general medicine and clinical practice, evidenced by experience in designing/conducting epidemiology studies, including Registries
Strong knowledge and experience in Global Pharmacovigilance guidelines, Risk Management and regulations; knowledge of international PV regulations is a plus
Experience with data mining software and applications
Demonstrated ability to function with a high level of autonomy and develop productive cross-functional collaborations
Ability to manage priorities, resources, and performance targets, in a changing environment
Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions
Company
Scholar Rock
Scholar Rock is a biopharmaceutical company that develops and discovers new medicines and treatments for the serious diseases.
51-200 employees
H1B Sponsorship
Scholar Rock has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2021 (4)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$743MKey Investors
InvusFidelityARCH Venture Partners
2024-10-08Post Ipo Equity· $300M
2023-10-11Post Ipo Equity· $85M
2022-06-17Post Ipo Equity· $205M
Leadership Team
Jay Backstrom
Chief Executive Officer
Recent News
Business Wire
2026-01-12
Morningstar.com
2025-12-13
Company data provided by crunchbase