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Medical Director - OB/GYN
Closing Date: September 1, 2010
| Company: | Ferring Pharmaceuticals, Inc.
Parsippany, NJ |
| Job Location: |
Parsippany - Morris County
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| Employment Type: | Full Time |
| Department: | Medical Affairs |
| Benefits: | Program, Vacation Program, Personal Days, and Holidays |
Description: | SUMMARY:
The Director, Medical Affairs is responsible for strategic and tactical planning and actions related to all aspects of budgeting and medical support for the Obstetrics and Gynecology (OB/GYN) Business Unit of Ferring Pharmaceuticals Inc. This includes designing and managing the processes related to the acquisition, organization, analysis, efficacy, and safety interpretation, reporting, presentation and publication of clinical and non-clinical data within the drug development process and for the support of marketing and sales efforts. This position supports the critical interface between scientific and commercial communities within the company and plays a pivotal role in Phase III-IV clinical trials, product development programs and all relevant FDA submissions for new product claims. The incumbent reports to the Vice President of Medical Affairs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Responsible for the overall budgeting and leadership of OB/GYN Medical Affairs
• Establish and maintain regular interactions with senior product and clinical management for strategic development issues and marketing operations; understands and contributes to product life-cycle management.
• Enhance scientific relationships with key opinion leaders; review promotional and educational material for accuracy; lead consultant and advisory meetings.
• Maintain a high level of technical expertise through familiarity with medical and scientific literature for the therapeutic area.
• Responsible for development of post-marketing clinical development plans including the design and management of clinical and non-clinical studies.
• Manage clinical and non-clinical study analysis process according to protocol and additionally explore/recognize/pursue trends in the data
• Interpret clinical and non-clinical study data in the context of existing literature and write/publish results
• Provide technical scientific/medical consultation to the commercial team to ensure accuracy and compliance with Ferring standards.
• Continuously review the competitive positions of projects and products, including competitor actions, to provide guidance for medical program needs.
• Contribute to periodic and annual drug safety assessments and reporting
• Contribute/develop topics for quarterly Medical Affairs/Sales Training purposes
• Participate in multidisciplinary projects designed to support the commercialization of Ferring products
• 25-30% travel
QUALIFICATION REQUIREMENTS:
• Board certified or eligible Obstetrics and Gynecology physician with 5 years or more of increasingly responsible positions in the pharmaceutical industry, including clinical project management, in the area of Obstetrics and Gynecology.
• Excellent communication and presentation skills, strong interpersonal skills.
• Strong Clinical Research/Medical Affairs background, and excellent problem solving abilities.
• Demonstrated abilities to work effectively in a team environment.
• Ability to interpret and evaluate clinical data.
• Leadership skills and ability to effectively and independently manage people, projects and timelines; ability to develop group synergy is essential
• Knowledge of pharmaceutical clinical development process and ability to effectively apply technical principles, theories, and concepts to clinical drug development.
• Knowledge of FDA, other regulatory agency and professional requirements, regulations and guidances
• Demonstrated ability to effectively present information to departmental management, interdepartmental teams and external audiences
• Experience with later stage development with demonstrated success as both a strategist and a tactician.
• Experience in product planning and development involving publication strategies, product monographs, promotional materials; DDMAC interactions is a definite plus
• Ability to develop medical/scientific data into clear, cogent vignettes, teaching programs and plenary presentations
• Commitment to provide leadership by example
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