Senior Director, Clinical Research-Medical Doctor

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.Job SummaryThe Senior Director, Clinical Research Neuroscience will be based in Collegeville, Pennsylvania, and report to the Assistant Vice President/ Neuroscience. The Senior Director will have full responsibility for the planning, implementation and daily operation of a drug development project (s). S/he will collaborate with key internal and external stakeholders, and may serve as the project medical monitor. Currently, Wyeth seeks a physician for the position of Senior Director, Clinical Research Neurosciences to ensure its continued success in this strategic therapeutic area through innovative research and outstanding scientific leadership.Job ResponsibilitiesDirect / Oversee the design and implementation of early stage Clinical Projects, as a member of our early Learn team(s),. Ensure that the overall scientific and medical content of all clinical programs is sound. Ensure the integration of pre-clinical and early clinical findings with planned clinical programs; work to secure cross functional alignment and / or transparent discussion of risks associated with clear plans to further investigate and track through clinical development. Lead the clinical team activities, including Study Teams and Clinical Project Teams under the Global Operating Model. Provide expertise and significant contributions to Clinical Project teams, Study Teams, Global Development Teams and Global Brand Teams. Direct the short and mid-range clinical research efforts, receiving drug development project planning and progress reports from Directors, Clinical Scientists and others assigned to the Project Team and Clinical Project and Study Teams on a global basis.Prepare clinical development plans and institute properly approved clinical protocols. Design scientifically rigorous and maximally cost-effective clinical development program for the desired indication(s). Present and defend protocols to CR&D Research Committee and Protocol Review CommitteesImplement clinical R&D policies, SOPs and related directives. Monitor study progress, leading the analyses and data evaluation process for progress reporting and presentations to senior management.Prepare various official and regulatory documents for Regulatory and other agencies, such as Dossiers, NDAs, INDs, Safety and Annual reports. Handling of responses to regulatory agencies regarding questions about complex safety or efficacy issues. Serves as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase II / III studies, managing the process from protocol development thorough individual study report and integrated regulatory documentation. Ensure that Serious Adverse Events are properly reported on a global basis.Manage multidisciplinary professionals and clinical scientists to support career and project advancement. Review potential in-licensing candidates and present recommendations to Senior Management groups. Support any needed due diligence and prepare / present medically sound strategy and plans associated with advanced opportunities.Contribute and support Department / Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional / organization processes designed to effectively deliver our R&D portfolio.Basic QualificationsMD with a valid medical license. Medical specialty and sub-specialty training and certification is highly desirable in Neurology. A fellowship or training and certification in Clinical Pharmacology is desirable. Clinical or research experience in field of specialization is highly desirable. Excellent oral and written communication skills, as well as interpersonal skills. Hard working, driven to achieve creative and sound results.Training required for all Wyeth Senior Executives.Prior experience in clinical research design/implementation of protocols, review/interpretation of data is required. This could be obtained through prior work in the pharmaceutical industry, Regulatory, or academic clinical research. 5 or more years of Industry related experience is desirable.Must demonstrate knowledge of the clinical development process and have direct clinical research and managerial experience.Knowledge of clinical trial management, data management, and drug development process.A detailed understanding of human disease, pharmacology, biochemical medicine and 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-PA-Collegeville Leading the way to a healthier world.