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 Senior Clinical Pharmacokineticist

Details
Country: USA
Location: Pennsylvania-Philadelphia Collegeville, PA 19426
Total applied: 40
Job Category:Biotech/R&D/Science
Location:Collegeville, PA 19426
Senior Clinical Pharmacokineticist

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 SummaryResponsible for devising and directing pharmacokinetic (PK)/ pharmacodynamic (PD) aspects of Early Development and Clinical Pharmacology strategies and plans for all IND-track and development compounds. Manages all aspects including scientific development and design, implementation, analysis, interpretation and reporting of PK/PD results in early and late stage clinical programs. Represents Early Development and Clinical Pharmacology at strategy, development and therapy area level teams and including regulatory meetings. Responsible for preparing and compiling clinical pharmacology aspects of global regulatory submission and documents. Job ResponsibilitiesLead preparation and execution of Early Development and Clinical Pharmacology plans and strategy to meet corporate, scientific and regulatory needs. Lead the design and implementation of clinical studies consistent with the Early Development and Clinical Pharmacology plan and oversee operational and scientific aspects of study conduct. Represent Early Development and Clinical Pharmacology on interdisciplinary project teams, including Learn/Confirm teams, clinical teams and subteams thereof as appropriate. Effectively communicate the Early Development and Clinical Pharmacology plans and results of Early Development and Clinical Pharmacology studies to Wyeth management and health authorities as appropriate.Ensure that Early Development and Clinical Pharmacology initiatives and messages are well supported through publication strategies and through manuscript publications and presentations at global meetings; champion Early Development and Clinical Pharmacology initiatives at clinical investigator meetings, advisory meetings and various scientific forums.Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of sophisticated pharmacokinetic and pharmacodynamic modeling and simulation initiatives, including population pharmacokinetic and pharmacokinetic/pharmacodynamic analyses.Provide mentoring and leadership to Early Development and Clinical Pharmacology staff and study team members. Ensure knowledge of Good Clinical Practice and Wyeth SOPs related to clinical study conduct.Basic QualificationsThe candidate must possess a BS in pharmacokinetics or a related discipline with 10 years of experience in pharmacokinetics, or a MS/PharmD with 7 years of experience in pharmacokinetics or a Ph.D. in pharmacokinetics or a related discipline with up to 2 years of experience in pharmacokinetics within the pharmaceutical industry. In-depth understanding of all aspects of PK/PD applications, especially in the area of pharmacometric application to drug development, is required. The candidate with industry experience should have on the job experience or training with a range of skills including pharmacokinetic analysis, population approaches in constructing PK/PD models, performing simulations and making predictions and have experience with pharmacokinetic software, statistical analysis software and modeling and simulation software such as NONMEM, SPLUS and/or SAS. In addition, the candidate with industry experience should have experience in preparing clinical pharmacology sections of various regulatory documents.The incumbent with industry experience should have experience within a team environment, strong presentation skills, collaborative skills, negotiation skills and demonstrate self-motivation. Training is principally on the job in the pharmaceutical industry. Relocation is 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.

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