Scholar Rock is a clinical-stage biopharmaceutical company focused on creating a robust pipeline of product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Our proprietary platform is built upon newly elucidated understanding of the molecular mechanisms of growth factor activation, which has led to the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.
Our lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation and is 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.
We are also advancing SRK-181, a highly specific inhibitor of TGFβ1 activation, into clinical development with plans to initiate a Phase 1 trial in patients with solid tumors in mid-2020. We believe SRK-181 has the potential to treat tumors resistant to checkpoint blockade therapy, such as anti-PD(L)1 antibodies.
Summary of Position:
Here is your opportunity to join a patient-inspired, creative, collaborative, fun and experienced team. Our mission is to help patients with serious illnesses by applying innovative thinking, cutting edge monoclonal antibody and protein science, and our passion towards discovering and developing novel therapeutics. Playing a critical role within Scholar Rock, the Medical Director, Safety Physician will be responsible for strategic medical leadership for global pharmacovigilance and risk management activities for the company. This position requires a highly motivated and enthusiastic medical professional with hands-on expertise in taking novel compounds from clinical candidate nomination through proof-of-concept and beyond. Key success factors for the position include rare disease and immuno-oncology drug development experience, creativity, integrity in thought and action, team-centric mindset, integrative thinking, ability to influence decision-making, exceptional communication skills, the ability to inspire, and being a “hands-on doer”.
- Leads and directs all aspects of pharmacovigilance activities for assigned investigational products including signal detection, signal analysis, communication and mitigation of potential safety risks
- Provides medical and pharmacovigilance expertise to lead decision making based on ongoing benefit-risk assessment, pharmacoepidemiological or clinical trial data interpretation, and risk evaluation and mitigation
- Authors, reviews and provides input for drug-safety related regulatory reports and clinical study documents including periodic aggregate reports, case series analyses, and regulatory submission documents
- Contributes to the development of internal processes including SOPs, Policies and Work Instructions
- MD required combined with 5 to 10 years of experience in pharmacovigilance and clinical safety
- Clinical experience with patients following post-graduate training is an asset
- Knowledge of principles of epidemiology and statistics.
- Critical thinking and analytical skills and ability to make high level decisions
- Proven history of successful involvement driving a strategic, global, cross-functional initiative.
- History of successful interactions with regulatory authorities, IRBs/Ethics Committees, medical community, knowledge of regulatory requirements for biologics