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Vacancy details
Vacancy description:
Job Code:
00271-2
Job Title:
Director of Medical Affairs
Job Category:
Physicians
Contract:
Permanent
Discipline:
Medical Director
Country:
United States Of America
Location:
New York
Min experience:
5 years
Annual salary:
Negotiable
Apply by:
13 Jun 2008
This key executive role is for a prominent global CRO that serves the pharmaceutical, biotechnology and medical device industries with full clinical trials management services throughout the clinical trials lifecycle through FDA and product registration support. They are seeking a MD with substantial clinical trials experience as Director of Medical Affairs at their office in Rye Brook NY to provide leadership and supervision with an Oncology focus within the Medical Affairs group.
JOB ROLE: The Medical Director will provide direct and supportive medical oncology services with responsibilities that include (but are not limited to):
•The successful clinical input and medical monitoring for multiple clients.
•Guidance and support to project teams.
•Interfacing with Sponsors and Regulatory authorities.
•Providing training to in-house staff on protocols and therapeutic areas specifically focusing on Oncology, ICH guidelines, and regulatory requirements.
•Working with Sponsors and Medical Affairs group in protocol development and/or review.
•Interacting with Clinical Safety department and Investigators regarding pharmacovigilance and study implementation.
•Managing all aspects of medical monitoring specifically focusing on Oncology.
•Ensuring that projects are adequately staffed with personnel and resources, and meet high quality standards.
•Providing guidance on medical and scientific issues, interacting with principal investigators and opinion leaders.
•Participating in business development presentations as required
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
•Medical Degree (MD)
•Medical license required. Board certification preferred.
•5-7 years industry experience including and at least 3 years clinical trials experience with drugs, devices or biologics.
•Management experience is preferred.
•Excellent knowledge of the drug development process.
•Experience with clinical development plans of new chemical entities, biological products and devices and experience working with or for a CRO is preferred
•Experience with CDER, CBER, CDRH and international regulatory agencies is a plus
PERSONAL SKILLS & ATTRIBUTES:
•Excellent time management and organizational skills.
•Computer proficient.
•Excellent verbal and written communications and interpersonal skills.
•Ability to work independently
•Strong leadership and management skills.
•Ability to handle multiple projects simultaneously and manage multi-functional teams.
•Creative problem solving skills.
BENEFITS OF THE ROLE: The Company is an equal opportunities employer and is offering an excellent executive salary for this position together with excellent benefits including: paid vacation/holiday time off, health, dental and life insurances, 401(k) retirement saving and profit sharing plan, tuition reimbursement and a flex-time policy.
Fforde is a uniquely specialised recruitment agency/business for the pharmaceutical, clinical research and biotechnology sectors with a glowing reputation in the industry and a high quality, personalised service dedicated to meet your career needs.
KEY WORDS: Director, Medical Affairs, Oncology, MD, Medical Oncology Services, Medical Monitoring, Protocol Development, Clinical Trials, Clinical Studies, Pharmacovigilance, Drug Development, Business Development, Medical Degree, Medical Licence, Board Certification, CDP, CDER, CBER, CDRH, CRO
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