Associate Director, Pharmacovigilance/Patient Safety

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, Pharmacovigilance Scientist, that is a creative, resourceful and integrative thinker. The person in this role works closely with the Drug Safety Officer and Head of Pharmacovigilance to provide leadership and technical expertise in a dynamic environment. The AD, PV Scientist will provide scientific/clinical expertise, strategic input, and support for deliverables, along with the opportunity to lead the build out of the signal management capabilities of Scholar Rock.
 
In addition the AD, PV Scientist will provide support for safety and benefit-risk evaluations for assigned products, management of potential safety issues for assigned products, evaluation of databases for safety signals, and drafting of responses to regulatory inquiries on product safety issues including oversight of aggregate reporting for all products within the product group. 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 of safety signal detection and management
    • Support clinical development activities such as developing the Reference Safety Information, Safety Sections of the Informed Consent
    • 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 Surveillance
    • MAA/BLA submissions
    • Developmental core safety information creation and updates
    • Periodic Reports (i.e. DSURs-authoring/working ‘from scratch’)
    • Development of Reference Safety Information/Investigators Brochure, Patient Informed Consents
    • Developmental Risk Management Plans (authoring/working ‘from scratch’)
    • Senior Safety Governance Board interactions (i.e. Safety Surveillance Committee)

Qualifications:

    • MSc or PhD 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
    • Demonstrable Patient Safety and/or Clinical/ Drug/Biologic Development experience across a range of activities
    • Strong working knowledge of PV regulations
    • Good understanding of epidemiology preferred
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees