Associate Director/Director, Clinical Development

Role Summary

Associate Director/Director, Clinical Development – provide clinical and scientific input and medical monitoring to early-stage clinical development programs, with a significant role in clinical study oversight, data review, trial design input, and communications to leadership and safety oversight committees.

Responsibilities

• Contribute to the scientific development of individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigators brochure, eCRFs, ICFs, CSRs)
• Perform review of clinical trial data (safety and efficacy), including medical monitoring and assessing for consistency and completeness and providing assessments and recommendations
• Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study
• Communicate a clear overview of trial results
• Collaborate with internal stakeholders (including clinical operations, data management, statistics, safety, regulatory affairs, among others) to ensure translation of the clinical protocol into operational deliverables
• Review and synthesize scientific literature and competitive intelligence to support study and program strategy
• Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials
• Drive and support preparation of scientific material for conference presentations or publications
• Contribute to the authoring and revision of regulatory submissions
• Perform analyses and generate scientific slide decks based on clinical, translational and other datasets

Qualifications

• Medical Doctorate (MD, DO, or equivalent ex-US medical degree).
• Associate Director: 5+ years of clinical/related research experience (including residency and fellowship)
• Director: 8+ years of previous experience in clinical/related research (including residency and fellowship) or industry experience
• Excellent oral and written communication skills and analytical skills
• Ability to work collaboratively in a fast-paced, team-based matrix environment; ability to assume multiple roles and responsibilities and meet stretch goals
• Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators

Skills

• Collaborative and team-oriented
• Analytical thinking and data interpretation
• Scientific communication and presentation
• Regulatory and compliance awareness

Education

• Medical Doctorate (MD, DO, or equivalent)

Additional Requirements

• Clinical experience in cardiovascular diseases or genetic medicines is a plus
• Advanced clinical training or a scientific degree (PhD, PharmD, MPH, etc.) is a plus
• Industry experience is a plus