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:
At Scholar Rock, we work in areas of unmet needs and take innovative regulatory approaches to bring life-changing treatments to those who need it. This position will serve as the regulatory lead for an oncology program, support orphan neuromuscular diseases and other products in earlier stages in the pipeline.
The Regulatory Affairs Associate Director/Director provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned product(s). You will contribute significantly to overall product and clinical strategy. The position plays a key role influencing regulatory authorities through regular contacts to improve regulatory outcomes.
Accountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products. Ensures that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. This includes health authority engagement strategy and considerations of expedited regulatory programs.
Lead cross-functional Teams in major health authority interactions. This includes setting the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.
Accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. Lead preparation of the regulatory strategy document and target product labeling.
Demonstrate strategic leadership skills contributing to effective product development.
Accountable for initiating and delivering key regulatory documents and plans.
Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
Ensures appropriate planning and construction of the global dossier and core prescribing information led by the respective teams.
May partner with other companies and regional regulatory affairs staff to influence developing views/guidance.
An advanced degree (MS or PhD/JD/MD) in a science related field and/or other appropriate knowledge/experience.
Previous demonstrated experience of regulatory drug development or equivalent (at least 6 years), and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired.
A solid knowledge of regulatory affairs within oncology or at least one therapeutic area in early and late development.
The ability to think strategically and critically and evaluate risks to regulatory activities.
A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in oncology therapy area (small molecules & biologics) is preferred.
Ability to work strategically within a dynamic work environment.
Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.