Director/Senior Medical Director
Our client is a biotechnology company. They have asked us to assist them in a search for a Director/Senior Medical Director.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Prepares and initiates study protocols in compliance with project plans, regulations, and good medical practice.
- Supports protocol or protocol amendment completion.
- Acts as medical monitor and/or supervises external medical monitors, for company sponsored trials.
- Support project teams with therapeutic area-specific information.
- Ensures an integrated and strategic approach to execution of study protocols.
- Analyzes and interprets clinical trial data and prepare reports for regulatory agencies, presentations at medical/scientific congresses, and publication.
- Works closely with clinical team to address questions from Health Authorities and Ethics Committees in a consistent fashion.
- Supports the development and compilation of regulatory filings.
- Reviews/co-authors medical publications emerging from clinical trial results.
- Develops relationships and interacts with clinical investigators and Key Opinion Leaders as appropriate.
- Acts as a liaison between company and clinical investigators.
- A Medical degree is required. Board certification or eligibility in oncology is preferred.
- Requires a minimum of three years of clinical development experience in the biotechnology or pharmaceutical industry, or equivalent combination of academic and industry experience.
- Must have hands-on experience in the design, execution, and reporting of clinical trials in oncology.
- Requires experience filing an IND.
- Must understand basic science relevant to clinical oncology.
- Requires the ability to effectively work in a cross-functional/matrix environment, utilizing strong organizational and time management skills.
- Effective leadership, people management, a team-oriented and results-oriented style and strong interpersonal, verbal, written, communication, and presentation skills are required.
- Must be flexible, creative, optimistic, and have a resourceful style and attitude.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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