I am searching for a highly motivated and qualified Executive Director, Clinical Development to join the team of a renowned biopharmaceutical business that is developing innovative treatments for cancer and fibrotic disease. This position will work closely with and report to the Chief Medical Officer.
This role will be responsible for the timely development and implementation of early clinical development plans and clinical trials across company's drug candidates in fibrosis and oncology indications. Some duties include trial design, protocol formulation, ensuring patient safety, managing data analysis, summary, review, and interpretation, as well as regulatory reporting. The Executive Director, will be in charge of the company's clinical initiatives and be in charge of ensuring that studies are successful.
Essential Duties & Responsibilities
- Clinical/Medical leadership of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA and other regulatory and health authority requirements
- Author and/or review clinical documents required for the conduct of clinical studies, including clinical protocols (and amendments), informed consent documents, investigator brochures, and safety management plans in compliance with regulations and good clinical practices
- Provide clinical leadership in clinical study and program teams, and lead clinical communication to upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and presenting a plan of action for resolution of issue
- Lead ongoing data review, analysis, and interpretation to understand safety and efficacy profile of the investigational drugs
- Generate/review clinical components of key documents in support of regulatory submissions, including clinical section of IND's and NDA's, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
- Ability to travel east coast, NJ as needed
- Medical Doctor (M.D.) - with board certification preferred
- Minimum of 10-12 years of clinical development experience in the pharmaceutical or biotechnology industries with at least 3 years involvement in oncology and fibrosis drug development
- Thorough working knowledge of clinical trial design, methodology, and statistical concepts
- In-depth knowledge of GCP/ICH guidelines
- Working knowledge of the IND/NDA process is strongly preferred
- This organization offers a competitive salary, bonus structure and stock options
- Full coverage of Medical Dental and Vision
If you are interested in the Executive Director of Clinical Development role please don't wait to apply!