Department: Development Team
Job Title: Medical Director, Clinical Development
Description:
POSITION SUMMARY: Play a hands-on role in the development of the Life Cycle Plan and new indications for Nexavar and future molecules. The candidate will become a member of the Onyx Clinical Development team. As such, this person will be the face person to medical/scientific key opinion leaders and oncology clinical community. They are also expected to have a significant influence on the day-to-day activities within the Clinical Development department and contribute toward the overall success of the Company.
RESPONSIBILITIES:
- In collaboration with the Vice President develops the strategic and operational plans for all activities within Clinical Development.
- Acts as a liaison to thought leaders, and develops excellent rapport with experts in therapeutic areas.
- Lead medical discussions at regional and national advisory board meetings as assigned.
- Contribute to the development of Nexavar through participation in a collaborative and cross-functional team environment.
- Lead a cross-functional team in the development of the Life Cycle plans for Nexavar and other molecules as required.
- Lead a cross-functional team in the development and publication of clinical trial protocols.
- Serve as the Medical Monitor of Development clinical Trials.
- Lead a cross-functional team in the writing and publication of scientific manuscripts which result from clinical trials and projects involving Onyx’s products.
- Responsible for the Medical review of educational and research grants for their scientific merit and consistency with the life cycle plan.
- Provide assistance to the Medical Director, Clinical Development in the administration of clinical trials in melanoma disease area.
- Will work in close collaboration with counterparts in Medical Affairs
- Will work in close collaboration with counterpart at Bayer Pharmaceuticals.
Job Requirements:
Education/Certifications/Licenses
· Requires a Medical degree
· Board Eligible/Certified
· Oncology Training preferred
Experience
· Minimum of 2 plus related clinical experience
· Prefer 3 – 5 years experience in this role within another biotech/pharmaceutical company and at least 2 years of management experience.
· Prior experience in a development organization is a plus.
· Professional knowledge and skills working with oncology patients and physicians.
· Working knowledge of FDA regulations preferred.
Knowledge
· Dynamic, self starter with strong influential skills.
· Ability to understand, interpret and explain scientific research and literature.
· Ability to relate and work with a wide range of people to achieve results.
· Exceptional written and verbal communication.
· Well spoken, confident, enthusiastic and charismatic.
· Strong time management and organizational skills.
· Ability to build working relations throughout the organization and with business partners to achieve business goals.
· Ability to manage multiple projects in a fast paced environment.
· Must have a solid understanding of drug development and life-cycle development of a product.
· Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building.
· Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through to requests from thought-leaders.
· An open and collegial style of interacting with co-workers.
· Willingness to travel extensively.
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