Associate Director, Clinical Research Oncology

Job Category: Biotech/R&D/Science Job Description:At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business. We are opening a search for an Associate Director within our Clinical Research, Oncology group at our Cambridge, MA research facility.Job SummaryThis position will have primary responsibility for leading the Global Torisel Development Team. In addition, dependent upon experience, this position will have broader strategic and operational responsibilities across parts of the Oncology portfolio, and management responsibilities for other MDs and/or Clinical Scientists. You will provide Clinical Leadership to include Global Medical supervision and project strategy development and: assure that the studies meet standards of good medical research; serve as Therapeutic Area representative to several global clinical teams; track progress of competition development strategies; facilitate the development of global medical opinions; evaluate benefits/risks of compound to support targeted clinical indications; management of Clinical Scientists, and possibly other Medical Monitors. You will work closely with Worldwide Regulatory Affairs and Regulatory Agencies to coordinate submissions; review and provide input into submissions and regulatory updates; work with writer /CPTL to review and sign off on annual reports to regulatory agencies; and meet with Regulatory Affairs to review submissions. You will be responsible for the management and review of medical and safety data and: oversee all study safety issues and medical decisions; monitor Adverse Events/Serious Adverse Events and abnormal laboratory findings and report these through the appropriate reporting process outlined in the SOP. You will oversee Clinical Trial Site Qualification & Selection and: review and authorize investigator and site selection; review and approve the investigator meeting agenda; provide protocol specific medical/scientific training to Study Teams, Investigators, site monitors and others; provide input and review /study Reference Manual and other study documentation; and participate in investigator meetings. You will also be responsible for CSR and Submissions support and: contribute to writing the Clinical Study Reports (CSR); work with the Writer to develop CSR strategy; review the draft CSR, data, tables and sign-off of the final Report; and support the writer in the revision/development of the Investigator Brochure. Basic QualificationsThis position requires an MD degree, board certification in Oncology (preferred) and/or significant (5-10 years) Oncology clinical research and development experience. Must have direct relevant clinical research experience in the oncology therapeutic area. Prior experience with design and implementation of clinical research protocols, review and interpretation of clinical data, and the overall drug development process is desired. Prior experience in the care of patients participating in clinical trials is desired. Also desired is a detailed understanding of the relevance of pharmacodynamic/clinical endpoints that underlie the action of the drug(s) being developed.Relocation is not available for this position. Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information and to apply online, please visit us at: www.wyeth.com/careers Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void. Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.Expected Travel Time: None Zip Code :US-MA-Cambridge Leading the way to a healthier world.