Medical Director – Senior Director, Clinical Research

Scholar Rock

. Provide medical leadership for clinical development activities of assigned pipeline products, including leading efforts to define clinical development strategy and plan .

Posted 9/22/2026full-timeCambridge • Massachusetts • United StatesSenior💰 $250,000 - $350,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates medical leadership in clinical development, including expertise in clinical study design, regulatory submissions, and data analysis while ensuring compliance with GCP/ICH regulations. Possesses strong critical thinking and communication skills to effectively collaborate with cross-functional teams and external experts.

Highest-signal resume keywords

MD Or MD/PhDClinical Development ExperienceInnovative Clinical Study DesignKnowledge Of ICH-GCP RegulationsExperience Interacting With Health Authorities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Development StrategyClinical Study DesignData AnalysisRegulatory Document AuthoringAdverse Event ReportingBiostatistics KnowledgePharmacokinetics KnowledgeRegulatory Pathway EvaluationLiterature ReviewDisease-Area Assessment

Soft Skills

Critical ThinkingExceptional CommunicationInterpersonal SkillsConflict ManagementTeam Player

Industry Keywords

Biopharmaceutical IndustryClinical TrialsDrug Development ProcessPre-INDBLAINDRegulatory FilingsPatient SafetyMedical MonitoringHealth Authorities

About the role

Key responsibilities & impact

Provide medical leadership for clinical development activities of assigned pipeline products, including leading efforts to define clinical development strategy and plan
Collaborate with development and research teams to build a collaborative culture and improve development-team effectiveness
Lead scientifically robust evaluation of development strategy and plans, including literature review, disease-area assessment, development-landscape analysis, and development/regulatory-pathway evaluation
Engage external scientific and clinical-trial experts and consultants to develop scientifically robust clinical-study designs
Author clinical and regulatory documents, including study concepts, protocols, investigator brochures, regulatory documents, and publications
Lead author clinical responses to regulatory authorities regarding protocols, INDs, BLA/MAA/JNDA, and other regulatory filings
Provide medical leadership and input across business development, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs, and drug safety
Provide medical oversight of clinical trials, including medical monitoring, adverse-event reporting, and patient safety
Provide medical and scientific leadership in data analysis and interpretation while maintaining integrity, rigor, and transparency
Work within applicable GCP/ICH regulations

Requirements

What you’ll need

MD, MD/PhD, or equivalent, based in greater Boston
Ability to be present regularly in the Cambridge MA office
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 industry, with 3+ years of clinical development 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%)