Associate Medical Director
The Associate Medical Director is responsible for management and review of clinical trials and product development. Specific tasks may include clinical protocol development, medical monitoring of clinical trials, analysis of study data, and preparation of trial reports and related regulatory documents. Additional roles in publication planning and writing may be included. The individual will interact with most departments within the company to ensure the successful progress of projects and clinical trials. This position will involve representing the company at scientific congresses, as well as at clinical and business development meetings.
Essential to success is excellent medical knowledge (particularly in malignant hematology), ability to build and maintain strong relationships with study investigators / key opinion leaders (KOLs), and outstanding internal partnerships (particularly with Pharmacovigilance and Medical Affairs).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide medical monitoring for Ph I - IV clinical trials, including patient enrollment, medical oversight of patients on study, providing guidance to investigators, review and analysis of adverse events, review of electronic data, and review of protocol deviations, protocol amendments, and informed consent forms. Initial priority will be monitoring of a Ph III clinical trial.
- Liaise with and manage external medical monitoring vendors/clinical research organizations (CROs), including oversight of CRO medical monitors.
- Collaborate on clinical development strategies for Phase I-IV programs, including review of investigator-sponsored trials.
- Providing review and input into advisory boards, educational materials, and publications.
- Work with cross-functional clinical team, including clinical operations, clinical pharmacology, pharmacovigilance, medical writing, statisticians, data management, and members of multidisciplinary project teams to guide data collection and data interpretation.
- Work with Regulatory Affairs and Pharmacovigilance to contribute to authoring and medical review of investigator brochures, safety reports, and other regulatory documents.
- Participate in company interactions with regulatory agencies.
- Must have knowledge of GCP, ICH and other regulatory requirements for evaluating and reporting adverse events, clinical trial data, clinical brochures and scientific publications.
- Travel for internal meetings or for external conferences or site visits, up to 10%.
· M.D. Degree, having completed residency in Internal Medicine or Pediatrics
· Excellent medical and scientific knowledge
· Working knowledge of Hematology / Oncology, with a proven track record of interpreting, discussing, and presenting efficacy and safety data relating to clinical trials
· Excellent writing / communication skills
· Knowledge of GCP and ICH guidelines, clinical development process, and basic medical statistics
· Board Certified or Board Eligible in Hematology and/or Oncology (highly preferred)
· U.S. medical license
· Oncology or Hematology drug development or clinical trial experience
· Track record of scientific publications, including manuscript and abstracts