Medical Director, Clinical Research

Role Summary

The Medical Director, reporting to the SVP, Clinical Research, will be a member of the late-stage development team, accountable for driving clinical development activities for product candidates from Proof-of-Concept through marketing approval and lifecycle management. The successful candidate will be responsible for providing medical leadership for clinical development activities for apitegromab as well as other product candidates entering late-stage development, in alignment with corporate strategy. This position requires a highly motivated physician scientist with hands-on expertise in advancing late-stage product candidates to deliver life-changing medicines.

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 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
• Drive scientifically robust evaluation of new opportunities, including disease area assessment, landscape analysis, evaluation of development and regulatory pathways, and development of study concepts
• Provide strategic guidance and support to the late-stage development team, including hands-on authoring, for the development 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

Qualifications

• MD, MD/PhD, or equivalent, based in greater Boston
• 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

Additional Requirements

• Travel: Domestic and international travel required; approximately 15% of time