Associate Director- MD, Vaccine Clinical Research

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 Summary The primary purpose of the job is to ensure that allocated bacterial vaccine clinical development programs are planned and implemented to meet company objectives. The Global Medical Monitor is accountable for patient safety and provides medical guidance during study design and execution. In addition to study level activities, the GMM will participate on Learn/Confirm Teams, participate in standing committees such as CRC, review compounds for potential in-licensing including performance of due diligence reviews and provide assistance to New Business Development on Market Opportunity and Target Product Profile. The GMM also may be required to design a Development Strategy with multiple protocols designed to obtain world wide approval for a compound or group of compounds. Job Responsibilities Accountable for safety across the study Review SAEs and determine if a follow up action is needed Participate in Safety Review Team (SRT) with Data Monitoring Committee (DMC) and steering committees as required Answer safety questions and review the literature as needed to answer these questions or those posed by SRT, DMC etc. Review and approved ICFs from sites. Where there are deviations from approved SRT wording review and obtain approval from TAD Safety communications to sites across the study Design protocol and strategy Design a clinical study to meet the requirements outlined in the Target Product Profile. Direct a Clinical Scientist in writing the synopsis and protocol including all required elements. Approve protocol and amendments Approve study template informed consent form Provide global medical input into country feasibility Coordinate with the Clinical Scientist to review and approve ADD/ IDRP/ CRF design deliverables Study Level Data Review Perform review of data generated by statistical analyses, eReview and SAE listings Request additional tables or analyses where appropriate Review individual data with SAEs and potentially clinically important signs or symptoms Perform all reviews and procedures required for database lock Reviews all patient narratives Trip Report issues trending Review outstanding medical or GCP issues report and address issues across the study. Provide Study Team with medical expertise during key activities Issue resolution Audit response Study closeout / inspection readiness. Participate in protocol and safety training Deliver protocol and safety training during Investigator meeting at the study level Create medical training materials for Site Management Specific medical/ protocol training for RSMs and SMs Site medical/ protocol training for use during investigator meetings Be available to answer questions specific to the protocol during (or soon after) the training from the Site Manager at SIV Answer medical/ safety questions and resolve medical/ safety issues from sites through Site Manager/ Regional Study Manager/ Regional Medical Monitor (RMM) if RMM is unable to answer specific questions, or as another point of contact if RMM is not available Questions from Sites on Protocol Answer medical and inclusion / exclusion questions Ensure answers are consistent across all regions Interact with regulatory groups and internal auditing groups on a study level Data Monitoring Committee Interaction Support Ministry of Health interaction Accountable for providing a response to regulatory agency inspection observations and internal audits Support regulatory update and registration submissions Contribute to, review, and edit Clinical Study Reports (CSR) Approve Patient Narratives Conduct decision point preparation for senior management Basic Qualifications Medical qualification. M.D./D.O. degree required, subspecialty and certification is highly desirable Good Clinical Practice ICF development Adverse events and handling Serious Adverse Events Study Design and Protocol Development Data review Clinical Study Report – preparation and review Regulatory submissions – elements of required documents in eCTD Residency plus several years clinical experience Medical and Safety expert Skilled in protocol design, interpretation, and medical conduct Knowledge and understanding of patient populations General therapeutic area knowledge 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.Expected Travel Time: None Zip Code :US-NY-Pearl River Leading the way to a healthier world.