Medical Director/Sr. Director, Clinical Research

Position Responsibilities

• 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

Candidate 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%)