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. The successful candidate will be responsible for providing medical leadership for clinical development activities 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.
Position Responsibilities- Provide medical leadership for clinical development activities of assigned product candidates, 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%)
