Medical Director, Clinical Research (Early-stage)

Cambridge · CambridgeFull-Timeexecutive

OtherMedical DirectorClinical Research AssociateLaboratory & Life Sciences

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Overview

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need.

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OtherMedical DirectorClinical Research AssociateLaboratory & Life Sciences

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.

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

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%)