Assistant Director Global Trial Leader

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 SummaryGlobal Study Leader will have ultimate responsibility and accountability for study execution. The GTL will need to collaborate and coordinate cross-functionally and cross-regionally to execute the study when taking corrective action to address major study level issues and when making major study and site level decisions. The GTL will support multiple studies and may span a program as the GTL as program size and associated workload allows.Job ResponsibilitiesPlan, manage and execute studyEnsure regulatory compliance and GCP adherence at the study levelTake corrective action for major study level issues (e.g. enrollment lagging across several regions)Make major site level decisions (e.g. final site selection) based on input from the teamPlan, facilitate, and lead study team meetingsProvide direct input into the protocol writing process on operational aspectsAccountable for protocol execution across a studyProvide input during budget creation to GCPLManages budget during study executionCreates and drives study level timelinesDevelops study level enrollment planCoordinate with functional areas and regions for input on study management – Study start up through database freezeManages and oversees resolution of study level issuesPlans and facilitates ADD process and meetingsAccountable for vendor selection across study with appropriate study team consultationFacilitate communication to the regionsEnsure training of RSMsGMM/CS develop RSM, Site Manager, and Site medical training materialsGTL develops operational training materials for the RSM, Site Manager, and SiteCollect and report study status for enrollment, data entry, study materials and other study status across regionsCollaborate with Drug Supply and CPD and RSMs to coordinate test article and non-drug supplies across regionsEnsure standard processes, tools, and procedures used consistently and globallyPlans, drives, and facilitates investigator meetingGenerates operational study level training materialsDirect global coordinationManage and guide study team cohesionCommunicate protocol changes or amendments to regionsWrite / Coordinate review of monitoring plan for entire study, across all regionsEnsure Regional Study Managers input for individual regionsEnsure medical input in consultation with the Clinical ScientistDrive study timeline across all regionsExecute global study managementEnd timelines trackingInteract with regulatory organizations at the study levelAccountable and responsible for coordinating all audit responses at the study levelCoordinate with CDPM to assure data capture and cleaning is acceptable with study timelines across regions (e.g track missing pages, outstanding queries, and drive the process to ensure timely resolution)Facilitate study close out activitiesEnsure complete close out of all sitesEnsure completion of final drug accountabilityEnsure audit readinessBasic QualificationsBS Degree in Health / Science preferred, non-relevant degree accepted with relevant experienceBS +7, MS/MA +5, PhD/Pharm D +2Basic scientific background and experienceDirect experience with monitoring and preferably managing clinical trials in industry or CRO.5+ years direct industry experienceGlobal Experience (Cultural awareness)Knowledge of processes for escalationKnowledge and understanding of all key elements required by others over the course of a studyExpert knowledge of GCP5 more years experience with clinical trials or equivalentScientific knowledge to adequately understand a protocol and medical terminology to review for operational execution feasibilityUnderstanding of Pharmaceutical R&D and/ or Clinical TrialsKnowledge of ADD / SAP process and ability to understand statistical informationKnowledge of Regulatory filingsStrong leadership and influencing without authority skillsAbility to interact cross culturallyNegotiation skillsStrong communications skillsAbility to manage cross functional team without direct reporting relationshipsStrong project management skillsRelationship building and conflict managementTimeline managementBudget management (to work with Finance)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.