Scholar Rock
Medical Director/Sr Director, Clinical Research
Cambridge, MA · Director
Sponsorship not specifiedDetected 78 days ago
GCPData AnalysisBusiness DevelopmentClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchExperimental DesignLeadershipBiostatisticsRegulatory Affairs
About the role
- As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures.
- Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
- Summary of Position: The Medical Director, reporting to the VP/SVP, Clinical Research, will be a member of the clinical research team, accountable for driving clinical development activities for assigned product candidates.
Responsibilities
- Collaborate with other members of the development and research teams to contribute to building a collaborative culture and improving effectiveness of the development team
- Serve as subject matter expert, leading efforts to provide scientifically robust evaluation of development strategy and plans, including robust literature review to perform disease area assessment, development landscape analysis, and development and regulatory pathway evaluation
- Engage with external scientific and clinical trial experts, clinical and regulatory consultants, to develop scientifically robust clinical study design
- Provide hands-on authoring of clinical and regulatory documents, including study concepts, protocols, investigator brochures, regulatory documents, publications, etc.
- Serve as lead author in clinical responses to regulatory authorities, related to review of protocols, INDs, BLA/MAA/JNDA, and other regulatory filings
Benefits
- Provide medical leadership for clinical development activities of assigned product candidates, including leading efforts to define clinical development strategy and plan
- 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
Company info
- Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases.
- Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity.
- Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases.
Equal opportunity
- Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
- Scholar Rock is an Equal Opportunity Employer.
Apply directly at Scholar Rock →Create a free account for alerts like thisView Scholar Rock immigration profile
This listing is sourced directly from Scholar Rock's careers page and normalized into a canonical job model.