Scholar Rock is a Phase 3, 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 now advancing apitegromab development through SAPPHIRE, an ongoing, randomized, double-blind, placebo-controlled, phase 3 clinical trial. 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:
The Associate Director, Regulatory Strategy, reporting to the Head of Regulatory, is responsible for the development and implementation of regulatory strategy and plan for assigned clinical and/or pipeline programs. As a subject matter expert, this individual will represent regulatory affairs at the appropriate program team, highlighting risks and opportunities to inform program strategy and plan. The successful candidate will lead interactions with the regulatory authorities, directing the preparation and submission of regulatory submissions and correspondence to the appropriate regulatory agencies.
Serve as a thought leader on regulatory affairs, defining regulatory strategy and plan to maximize regulatory success
Provide strategic and operational input to program team to achieve program objectives while ensuring compliance with applicable regulatory requirements
Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan
Serve as point of contact with regulatory authorities, leading and managing regulatory interactions, building trusted relationships with regulatory authorities
Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., IND, briefing documents, DSUR, BLA)
Ensure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory success
Identify regulatory risks and opportunities and work with key stakeholders to develop solutions
Provide regulatory input and support for business development activities
Partner with market access and medical affairs colleagues to support interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable
Ensure strong representation of regulatory voice at key governance bodies and teams (e.g., PRC, program teams, clinical development teams, study teams)
Maintain currency of regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance
Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed
Education in life sciences required
Located in the greater Boston area preferred
5+ years of experience in biopharmaceutical industry with broad experience in regulatory affairs and drug development
Demonstrated experience of leading successful engagement with key regulatory agencies (e.g., FDA) from preclinical through approvals required
Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred but not required
Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills
Strong written, verbal communication skills, and interpersonal skills
Capable of managing shifting priorities in a rapidly changing and environment
Ability to travel domestically and internationally (~10%)
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.