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Scholarrock

Medical Director, Clinical Research (Early-stage)

Scholarrock Cambridge, MA 38 days ago
healthcare
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
 
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

The Medical Director, reporting to the VP, Clinical Research, will be a member of the early development team, accountable for driving clinical development activities for product candidates from IND through Proof-of-Concept. The successful candidate will be responsible for providing medical leadership for clinical development activities of follow-on indication(s) for apitegromab as well as new product candidates, in alignment with corporate strategy. This position requires a highly motivated physician scientist with hands-on expertise in advancing product candidates to deliver life-changing medicines.

Position Responsibilities:

  • Deliver clinical development plan for assigned pipeline products from IND through Proof-of-Concept
  • Provide medical leadership for clinical development activities of pipeline product candidates, including new indication assessment
  • Collaborate with other members of the development and preclinical research teams to contribute to building a collaborative culture and improving effectiveness of the development team
  • Engage with external scientific and clinical trial experts, health authorities, and consultants, to develop scientifically robust development plans
  • Drive scientifically robust evaluation of new opportunities, including disease area assessment, landscape analysis, evaluation of development and regulatory pathways, and development of study concepts
  • Provide strategic guidance and support to the early development team, including hands-on authoring, for the development of clinical development plans, study protocols, investigator brochures, regulatory documents, publications, etc.
  • Provide medical leadership and input in cross-functional team activities, including business development activities, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs and drug safety
  • Responsible for medical oversight of clinical trials, including medical monitoring of studies, adverse event reporting, and patient safety for all clinical trials across a development program. 
  • Provide medical and scientific leadership in data analysis and interpretation, maintaining integrity, scientific rigor, and transparency
  • Work within compliance to all applicable GCP/ ICH regulations

    • Candidate Requirements:

  • MD, MD/PhD, or equivalent, based in greater Boston
  • Strong critical thinking skills, with ability to synthesize complex information, and exceptional communication skills, both verbal and written
  • 5+ years of experience in the biopharmaceutical clinical development function, with 3+ years of clinical development leadership experience; neuromuscular or rare disease experience preferred but not required
  • Highly organized, outcome-oriented, self-motivated team player with strong interpersonal skills and effective conflict management skills
  • Experience in innovative clinical study design, analysis of clinical data, publications, and working knowledge of biostatistics and pharmacokinetics/pharmacodynamics
  • Understanding of the drug development process from pre-IND through BLA
  • Experience interacting with health authorities in the US and EU
  • In-depth knowledge of ICH-GCP and other application regulatory guidelines
  • Ability to travel domestically and internationally (~15%)
    • Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. 

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