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?
The VP & head of Clinical Development for Neuromuscular Therapeutics, reporting to the CMO, will be a member of the development leadership team. The successful candidate will be responsible for leading a team of Medical Directors and Clinical Scientists, providing strategic and medical leadership for all clinical development activities of product candidates in the neuromuscular therapeutic area, from pre-IND and first in patient through approval, in alignment with program strategy. The successful candidate will be an integral member of the program team. This position requires a highly motivated and enthusiastic physician with hands-on expertise in advancing product candidates initially through proof-of-concept and subsequently through registration.
The work you'll be doing:
Lead a team of Medical Directors and Clinical Scientists, ensuring strong representation of clinical development at the program team and development leadership team
Provide medical vision and leadership in the creation and execution of development strategies in order to establish a clear path initially to clinical proof-of-concept and ultimately to regulatory approval
Provide medical and scientific leadership, including hands-on authoring, for the development of clinical development plans, study protocols, Investigator Brochures, submission/ registration documents, publications, etc.
Provide medical leadership and input in cross-functional project team activities, including business development activities, discovery, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs and drug safety.
Responsible for providing or supervising medical monitoring activities in support of AE reporting and patient safety for all clinical trials across a development program
Liaise with investigators, US and Ex-US health authorities, IEC/IRB, consultants, KOLs, SABs, academic institutions and CROs, elucidating the scientific rationale and vision for the clinical programs
Expertly analyze and interpret data, and clearly communicate results both internally and externally to a variety of audiences
Lead efforts to identify, build relationships and communicate with key investigators and trial sites
Medically lead the evaluation of new indications for muscle-related therapeutics, and formulate and execute development strategies to pursue them
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
10+ years of experience in the biopharmaceutical clinical and/or medical function, with 5+ years of clinical development experience
Expertise in innovative clinical study design, analysis of clinical data and publications and working knowledge of biostatistics and pharmacokinetics/pharmacodynamics
Understands the drug development process from pre-IND through BLA
5+ years of experience in clinical R&D as investigator and/ or within the pharmaceutical/ biotech industry
Experience interacting with health authorities in the US and EU
In-depth knowledge of ICH-GCP and other application regulatory guidelines
Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
Ability to forge and nurture key partnerships and collaborations with the external scientific community
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.