Study Director

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.Job SummaryThe Toxicology Study Director will plan, direct, and interpret safety studies on new drug candidates taking overall responsibility for these studies in accordance with GLP and other regulatory guidelines. Duties include overseeing, coordinating, and participating in the preparation of technical regulatory documents relating to those studies. He/she will represent Drug Safety on project teams and facilitate communication of safety issues to and from project team members. Works with general supervision and need for consultation with management on day-to-day operations.Job ResponsibilitiesAs GLP Study Director, plan direct and interpret short and long term toxicology studies in laboratory animals on new drug candidates. Serve as study team leader and ensure coordination of all parties contributing to study data (study team members) including Study Toxicologist, Study Supervisor, and Study Technician. Related responsibilities include:Prepare study designs for routine and special studies. Oversee the drafting of protocol outlines, study protocols, IACUC documents and other written materials consistent with the study designs approved by reviewing committees (e.g., PRC).Monitor the technical conduct of studies for adherence to protocol and for development of toxicologic effects. Report regularly to management on the progress of these studies.Direct the preparation of study reports, ensuring appropriate quality control procedures are used and effective and that schedule is maintained. Provide interpretation of results and integrate information provided by other groups (e.g., pathology and drug metabolism).Perform similar oversight duties as Principal Investigator for studies directed by Drug Metabolism personnel.Monitor designated studies at contract laboratories, serving as their principal liaison and communicating developments to Wyeth Research management, as appropriate.Provide summaries of safety information for inclusion in submissions to regulatory agencies, assuring accuracy and readability within format guidelines. Work closely with document preparation staff to review and edit the overall documents and to integrate contributions from other groups (e.g., reproductive toxicology, drug metabolism).Represent Drug Safety on multi-disciplinary project teams.Participate in Drug Safety and Metabolism Protocol Review Committee, Project Review and other meetings involving multi-disciplinary review of drug safety data and department policy. Prepare and update SOPs.Keep abreast of major developments in drug safety, recommending implementation of appropriate methods or acquisition of appropriate instrumentation.Basic QualificationsRequirements vary based on grade level. External candidates must have a Ph.D with 0-12 years of relevant experience. Internal candidates must have a BS with 10-12 years of relevant experience or an MS with 8-10 years of relevant experience.Training in Good Laboratory Practices, Drug Safety Evaluation Standard Operating Procedures, pharmaceutical industry or other aspects of toxicology studies.Experience in conducting toxicology studies. Good human relations and writing skills necessary. Ability to motivate and direct employees, understanding of Good Laboratory Practices and Standard Operating Procedures.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.Job Experience:See above.Expected Travel Time: None       www.wyeth.com/careers Wyeth is an equal opportunity employer that shares the vision of a diverse workplace. 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.