Scholar Rock

Sr. Medical Director, Drug Safety & Pharmacovigilance

Cambridge, MA · Director

Sponsorship not specified$280k-$420kDetected 371 days ago

Process ImprovementClinical TrialsClinical ResearchPharmacovigilanceResearchLeadershipCommunicationOrganizational Skills

About the role

As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures.
Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Medical Director, Drug Safety & Pharmacovigilance is a key position within the company and safety department, with significant impact on the development and life cycle of drug development projects.

Lead and support development of pharmacovigilance strategies for products within Therapeutic area, to ensure compliance with corporate clinical development and commercial goals.
Oversee and collaborate with internal safety scientists within TA
Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., DMCs, Vendor oversight meetings, etc.)
Support process improvement and functional training at departmental & company level
Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services.
Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement.

5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
Strong understanding of pharmacovigilance regulations in the US and EU.
Experience in supporting drug safety activities in registrational clinical studies
Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.
Strong track record of delivering results through effective team and peer leadership in matrix
Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.
Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws.

Responsible for oversight and conduct of Product Safety Committee (PSC) meeting(s) to evaluate risk-benefit for the compounds with support from cross-functional teams.
Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR))
Ensures vendor oversight of outsourced Medical activities, as applicable.
Ability to be flexible and adapt quickly to the changing needs of the organization.
Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations
MD or MBBS or MD-PhD or equivalent medical degree
High level of medical competence, with an ability to balance this with industry standards to achieve business goals

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases.
Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity.
Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases.

This listing is sourced directly from Scholar Rock's careers page and normalized into a canonical job model.