Deliver clinical development plan for pipeline products from Proof-of-Concept through marketing approval and lifecycle management
Provide medical leadership for clinical development activities of assigned pipeline products
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
Provide strategic guidance and support to the late-stage development team, including hands-on authoring, 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

Requirements

MD, MD/PhD, or equivalent
Based in greater Boston with 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 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%)

Benefits

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical developmentclinical trial designdata analysisbiostatisticspharmacokineticspharmacodynamicsregulatory document authoringadverse event reportingmedical monitoringstudy protocol development

Soft Skills

critical thinkingcommunicationorganizational skillsself-motivatedinterpersonal skillsconflict managementcollaborationstrategic guidanceleadershipsynthesis of complex information

Certifications

MDMD/PhD