VP, Head of Clinical Development, Neuromuscular Therapeutics

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
    • Highly organized, outcome-oriented, self-motivated performer
    • 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%)

• • • 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.