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:
Want to change the world? Have fun while doing it? Here is your opportunity to join a patient-inspired, creative, collaborative, dedicated, and experienced drug development team that deeply believes in this vision. Our team strives to help patients with serious illnesses by applying innovative thinking and passion towards developing cutting edge monoclonal antibody therapeutics. Around here, we don’t do the “that’s the way it’s been done for a thousand years, so that’s the way we’re going to keep doing it”. Out of the box, in the box…it doesn’t matter. We’re here to do amazing things and want to do what makes sense and is right. Through our science, let’s go and make the world a better place. And, did we already mention have fun while doing it?
Scholar Rock is searching for an experienced Medical Director or Senior Medical Director to serve as the study medical lead for one or more of company sponsored studies of the apitegromab program. Reporting to the VP of Clinical Development Neuromuscular, the successful candidate is accountable for providing medical leadership in the development and execution of clinical trial strategy and plan, in close partnership with program team. This individual will be responsible for the design, conduct, and interpretation of clinical studies, ensuring ethical and scientific integrity of the studies in compliance with Good Clinical Practice.
The work you'll be doing:
Provide medical and strategic leadership for the clinical development plan related to one or more studies of the apitegromab program, in close partnership with the program team.
Develop medical content and provide medical expertise for study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions.
Serve as the medical monitor for one or more clinical studies, including reviewing and approval of medical monitoring plan, safety plan, and protocol deviation plan, as well as day-to-day study related medical decisions.
Serve on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analyses.
Contribute medical content and expertise in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate, and interface with regulatory authorities as appropriate.
Provide medical leadership for cross-functional teams, including external innovation/business development.
Represent SRRK to outside medical personnel in the development of clinical protocols and study conduct; represent SRRK to outside stakeholders.
Provide content leadership in the analysis and interpretation of clinical trial data and drive timely communication of data both internally and externally.
Provide medical leadership in cross-functional effort in the evaluation of new indications for muscle-related therapeutics.
Work within compliance to all applicable GCP/ ICH regulations
The expertise we're looking for:
MD, MD/PhD, or equivalent
Drug development experience required; clinical development experience in neurology and/or neuromuscular therapeutic area highly desired but not required
3+ years of experience in the biopharmaceutical clinical and/or medical function, with 2+ years of clinical development experience
Expertise in innovative clinical study design, analysis of clinical data and publications and working knowledge of biostatistics and pharmacology
Understands the drug development process from pre-IND through BLA
3+ years of experience in clinical R&D as investigator and/ or within the pharmaceutical/ biotech industry
Ability to work collaboratively in a fast-paced, team-based matrix environment.
Ability to work independently to resolve challenges with strong interpersonal and communication skills.
In-depth knowledge of ICH-GCP and other application regulatory guidelines
Excellent interpersonal skills and conflict management and negotiation skills
Ability to travel domestically and internationally (~20%)
The Special Traits of the Ideal candidate:
Energized by a vision to change the world through innovation (in both what we do and how we do it); a catalytic leader who strives to make that happen
Integrity in thought and action, creativity, team-centric mindset, integrative thinking, ability to influence decision-making without dictating, exceptional communication skills, the ability to inspire, and being a “hands-on doer” who leads from the front, not a “politician or presider”
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.