The Medical Director is responsible for the planning and conduct of clinical trials. The Medical Director will assure the medical and scientific integrity and GCP compliance of clinical trials conducted by the company in an assigned therapeutic area. The Medical Director is responsible for setting and achieving goals and meeting timelines in accordance with corporate goals and with projected resource projections and budgets.
Duties and Responsibilities:
- Assists in defining the global development strategy for clinical research and management of new compounds in the clinical setting.
- Establishes and approves scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports.
- Manages and improves the clinical development process and execution of clinical studies worldwide.
- Establishes and reviews Protocols, Investigator Brochures, study reports and other documents. Ensures that study protocols are medically appropriate, feasible and operational.
- Serves as the Physician with primary responsibility for adequate conduct of the studies in accordance with FDA and GCP guidelines with responsibility for:
- Assures appropriate preparation of documents for submission to regulatory authorities.
- Establishes and maintains clinical trials documentation systems and clinical tracking systems that conform to GCP guidelines
- Evaluates and selects clinical study sites, negotiates of study contracts and plans and manages of clinical-trials budgets.
- Oversees planning and management of investigator meetings, including budget negotiations.
- Serves as primary company liaison for internal and external CRA’s, CRA managers, and project team members regarding all aspects of study conduct.
- Identifies and manages consultants or outside service providers for managing, monitoring, or reporting of clinical trials. Oversees the selection and management of external contractors, including CROs, central labs and other relevant vendor services.
Serves as the Medical monitor for those studies and participates in adverse event monitoring, evaluation and reporting.
Has principal responsibility for heading a team of clinical professionals and for the management of one or more clinical programs.
- Defines and supervises project specific performance of external contractors, including contract research organizations; establishes scope of work; negotiate budgets and contracts.
- Assures proper training of your reports to include compliance with Title 21 of the Code of Federal Regulations and adherence to FDA guidelines
- Assists in reviews and updates of clinical SOPs.
- Appraises clinical resource needs and allocations and conveys those needs to clinical project/management teams
- MD degree, board certified.
- Medical and/or clinical science.Skills:
- Exceptionally good interpersonal, verbal and written communication, and organizational skills.
- Must be an excellent communicator with proven leadership skills and the ability to interact in a cross functional environment.
- A self-motivated team player with ability to motivate others in a team setting.
- Ability to function efficiently, effectively and at times independently in a fast-paced, changing environment.
- ITCA 650 training program; CVEAC; DSMB; REMS
10 years’ experience in biotech/pharmaceutical industry