Associate Director, Patient Safety/Pharmacovigilance Operations Lead

Cambridge, MA
Regulatory Affairs
Full-Time
Scholar Rock is a clinical-stage biopharmaceutical company creating a robust pipeline of therapeutics with the potential to transform the lives of patients suffering from serious diseases, including neuromuscular disorders, cancer, fibrosis, and anemia. Our proprietary platform is rooted in our structural biology insights into the activation of latent growth factor precursors and drives the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.  By exploiting structural differences in the precursor, or latent form of growth factors, Scholar Rock intends to avoid the historical dose-limiting safety challenges associated with inhibiting the mature form of growth factors for therapeutic effect.
 
Our lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation currently being evaluated in a Phase 2 proof-of-concept trial for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). SRK-015 has received Orphan Drug Designation in both the US and EU.
 
Our second product candidate, SRK-181, is a potent and highly selective inhibitor of latent TGFβ1 activation.  A Phase 1 proof-of-concept trial will be initiated in Q1 2020 in patients with solid tumors. We believe SRK-181 has the potential to meaningfully increase the number of patients who can benefit from checkpoint inhibitor therapy by overcoming primary resistance to anti-PD-(L)1 antibodies.
Summary of Position:

Scholar Rock is seeking an Associate Director, Patient Safety/Pharmacovigilance Operations, that is a creative, resourceful and integrative thinker. The PV operations lead will work closely with the Head of Pharmacovigilance in the creation and implementation of a PV operations program at Scholar Rock.  Furthermore, the PV Operations lead will be responsible for ensuring the proper execution and implementation of PV operational activities in support of study management teams, clinical operations while meeting external stakeholder expectations for PV operational excellence.  This is a unique opportunity for an enthusiastic and collaborative individual interested in contributing to the development of transformative products for patients with rare and oncologic diseases. 

Responsibilities:

    • Lead the build out and operational oversight of pharmacovigilance operations for Scholar Rock
    • Provide internal and external support for PV operations for all Scholar Rock developmental assets 
    • Demonstrable experience working in or leading safety &/or scientific activities in at least 3 of the following areas:
    • Clinical drug development (Early and/or Late Phase) Safety Operations
    • CRO management of Individual case safety report processing and submissions
    • Led or participated in the migration of safety databases
    • Authored pharmacovigilance operations standard operating procedures
    • Health Authority inspection participation as a subject matter expert for PV Operations 

Qualifications:

    • BSc or MSc or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline (e.g., oncology, metabolic diseases, rare diseases etc.) with demonstrated experience with the responsibilities, deliverables, and skills
    • Expertise of local and major market global pharmacovigilance regulations
    • Experience with pharmacovigilance operations with co-development partnerships
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees