12 days ago
The Vice President of Clinical Development is responsible for the development of clinical research strategies and direction of Phase 1-3 clinical studies while working with cross-functional teams. S/he will be responsible for study design, development, data readout, and summary. This position will also provide ongoing input into assessment and interpretation of safety data and contribute to investigator training.
- In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.
- Provide clinical/scientific input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions.
- Must possess sound scientific and clinical judgement with ability to properly interpret clinical trial data.
- Familiarity with concepts of clinical research and clinical trial design, including biostatistics.
- Support the development of key scientific relationships with external opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings.
- May serve as Medical Monitor responsible for the safety monitoring of clinical trials, and as the medical expert for clinical studies.
- Participate in preparation of abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
- Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety Physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies.
- Provide periodic status updates and effectively communicate with Senior Management Team.
- Support the development of regulatory documents for filings and agency meetings and participate in interactions with regulatory agencies.
- MD degree
- Accredited residency training and board certification in relevant clinical specialty.
- 2 to 10 years’ experience in pharmaceutical and/or biotechnology industry developing investigational new drugs or experience in a clinical research organization involved in clinical trials.
- Experience with drug development in metabolic diseases (preferred).
- Ability to work with a high level of autonomy/independence.
- Review and interprets scientific knowledge of competitor landscape (molecule / indication).
- Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience with FDA and other health authorities strongly desired. Skills and Attributes