Medical Director/Sr Director, Clinical Research

Position Responsibilities:

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