Senior Director - Medical Affairs Women's Health - Actavis - New York

Job description

Medical Affairs is responsible for ensuring that the organization has world class knowledge of the therapeutic areas both from a medical development and a medical practice standpoint. The Sr Medical Director of Medical Affairs, Women’s Health is a key strategic leader in this structure. Working in partnership with the clinical development team members, under the leadership of the VP Medical Affairs, the Sr. Director Medical Affairs will develop a comprehensive medical strategy for each of the products in the Women’s Health therapeutic area. This leader will provide insightful medical practice insights to support the clinical development, HEOR, publications, marketing, sales, and regulatory functions to ensure that they are developing product and development strategies that will be relevant to the market - patients, payors and physicians.

Function as key strategic partner with Clinical Development, HEOR, Marketing, Regulatory, and Legal teams to execute medical life cycle plan; implementing strategies and tactics in support of brand development in the defined therapeutic area.
Direct the coordination and utilization of scientific information that may be used by various internal stakeholders in support of marketed product(s) and drugs in development within the defined therapeutic area; this will include the establishment of relevant Advisory Boards.

Provides strategic medical practice input to the Product Development Teams to ensure that appropriate phase IIIb and Phase IV studies are planned and executed to provide practice relevant data on the marketed products. In addition, provide inputs from medical practice perspective to HEOR team for real world studies as needed.
Within the context of the strategic development and brand plans for each product and the therapeutic area, evaluate proposed research concepts and protocols for investigator initiated studies (IIT), assessing such IITs for medical/scientific merit, appropriate design and strategic fit for the product.
Establish and maintain relationships with Key Opinion Leaders (KOLs) in respective therapeutic area to establish strong scientific presence in the practicing and academic communities. Collaborate with External Medical Affairs to ensure KOL cultivation/communication is optimized. Collaborate with HEOR to establish scientific & clinical credibility with payers, managed market/market access (ex-US) and healthcare decision makers.
In partnership with the marketing team, design and review promotional materials to ensure medical and scientific content is accurate, balanced, and competitive and provides input to the review process to ensure the best promotional materials are developed.
Ensures that the training of external teams and/or sales professionals, on various aspects of scientific information specific to Forest products and on related medical/scientific information concerning the therapeutic area, is accurate and balanced to communicate the complete data about products.
In collaboration with the Sr. Medical directors of the other TAs, attends periodic meetings of the publication team, reviews all materials for publications, and coordinates activities with publication/communication group.
Directs the reviews of medical information and communication materials for medical and scientific content.
Stays informed of current developments in the medical and scientific communities concerning assigned areas through appropriate familiarity with current literature, attendance at meetings, conventions, and professional associations.
Act as external spokesperson to KOLs, Payors, Professional Societies, and Advocacy Groups. Key internal contact for Advocacy groups of global importance.
Provides support for sales training initiatives for current products and drug product launches; reviewing and creating training materials and participating in clinical product training for sales representatives and others.
Responsible for IME for products within assigned therapeutic area.
Represent MA and hence medical practice in label negotiations with FDA.

Desired Skills and Experience

MD degree from an accredited US or foreign medical school with at minimum two or more years of postgraduate medical training required. (OB/GYN highly preferred). Clinical practice experience highly sought after and reasonable ongoing patient care responsibilities will be accommodated.
Pharm. D will be considered.
Experience:
Must have solid understanding of legal and regulatory guidelines; knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals. Ex-US experience preferred, but not required.
Progressive experience in pharmaceutical industry, biotechnology company in medical affairs function. Minimum 3 years therapeutic area relevant experience required.
Minimum 7 years work experience within the pharmaceutical/biotech industry

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