Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.
Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are planning to advance to a Phase 3 trial by year-end. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.
By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.
Summary of Position:
Our mission is to help patients with serious illnesses by applying innovative thinking and execution, cutting edge science, and our passion towards discovering and developing novel therapeutics. Playing a critical role within Scholar Rock, the VP of Regulatory Affairs will be responsible for driving the global regulatory strategy and its execution. This position requires a highly motivated and talented regulatory professional with strong leadership and expertise in advancing novel compounds from clinical candidate nomination through proof-of-concept (POC) as well as from post-POC through approval and beyond.
Lead global regulatory strategy and execution for all research and development programs at Scholar Rock
Build an innovative, world-class, and patient-centric regulatory affairs organization
Play a key role in overall R&D strategy and decision-making
Develop and sustain strong relationships between Scholar Rock and regulatory agencies around the world
Inspired by and dedicated to our company’s mission to transform the lives of patients affected by serious illness
Expertise and experience with biologics across the full development path from pre-clinical to approvals and beyond, with a track record of successfully advancing multiple product candidates through global approvals
Significant, broad expertise with regulatory strategy globally (not just the U.S.) and directing interactions with regulatory authorities
Strong leadership of not only of one’s direct reports and organization but also cross-functional teams
Demonstrated versatility working within multiple therapeutic areas, with rare diseases/orphan drugs a strong plus
A Medical or Scientific background is a significant plus, given the highly innovative nature of our R&D efforts
Creative and flexible but also simultaneously able to keep the team’s efforts disciplined, diligent, and on-time
Highly integrative thinker who understands and considers issues from an inter-disciplinary perspective
Performs well in an informal, dynamic, highly cross-functional culture (which places importance on strong teamwork and morale)
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.