Senior Clinical Program Manager

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 SummaryProvides clinical project management support for early- and/or late-phase development-track programs in support of the Learn and Confirm Model with a focus on schedule analysis, issue identification, problem resolution, and support for registrations. Develops and maintains clinical timelines in support of project milestones and decision points from development-track decision/pre-IND filing or in-licensing to initiation of phase 3, and/or from initiation of phase 3 through registration and post-registration commitments. Identifies clinical issues with a potential impact on the achievement of project milestones and facilitates resolution to ensure that timelines for clinical deliverables are met. In late-phase development, provides leadership to the Clinical Registration Team (CRT) and coordinates clinical activities related to submissions. Works with the Clinical Project Team (CPT), CPT Leader, other Clinical Program Managers, and other GCT and non-GCT personnel to maintain continuity for the projects within the therapeutic area. Is skilled in project management tools and techniques. Job ResponsibilitiesUnder the guidance of a senior-level Clinical Program Manager (CPM), provides clinical project management support for projects from development-track through initiation of phase 3, or from initiation of phase 3 through submission(s), approval, and post approval commitments, using effective leadership and project management techniques. Ensures global focus of tasks and processes. Participates on the CPT and Learn and Confirm sub-teams as appropriate. Supports the Learn and Confirm Teams and associated sub-teams in the achievement of major project milestones. Monitors project flow, identifies and evaluates issues and presents/implements strategies to ensure that timelines are met or accelerated. Under the assistance/guidance of a senior-level CPM, as late-phase development CPM, provides leadership for the CRT and works with CRT members to coordinate activities for completion of clinical submission deliverables. Serves as key representative on the Confirm Team Registration Subcommittee to coordinate clinical submission requirements. Conducts CRT meetings to address and resolve issues, and to monitor the progress of activities related to the submission. Provides accurate and concise summaries of CRT meeting results. Documents and analyzes successes, issues, and resolutions, and facilitates discussions for CRT ‘lessons learned’ process. Prepares final close out report for the CRT.Meets regularly with CPT Leaders, Clinical Trial Directors, and Learn and Confirm Team leaders and project managers to review status and issues involving the projects and potential impacts to project success. Monitors and ensures consistency and compatibility among projects and within the therapeutic area. Meets regularly with Clinical Trial Managers and Study Team Leaders as appropriate to monitor study progress and issues as they relate to project decision points and milestones.Develops, maintains, and analyzes project-level (including clinical registration) schedules and critical path tasks to ensure accuracy and efficiency/timeliness in meeting project milestones. Interfaces with other CPMs in early- or late-phase development to ensure consistency and compatibility with overall project goals. Analyzes project schedules to assess, identify and communicate GCT resource needs.Routinely communicates project status and issues to management, in formal presentations and upon request. Follows up on actions/resolutions, and communicates results of management input to the CPT, CRT, and Learn and Confirm Teams and sub-teams as appropriate. Provides accurate and concise summaries of clinical programs for assigned therapeutic area(s), and monitors/updates progress on GCT objectives on a monthly basis for GCT website communication. Facilitates and monitors routine project-level activities/requirements (IND Annual Reports, Safety Review Team Meetings, etc.). Maintains all appropriate departmental reports for assigned projects and programs. Monitors and updates progress on GCT objectives, and maintains all appropriate departmental reports for assigned projects and programs. Is responsible for the accurate and timely entry of project-level information in IMPACT (clinical administrative database). Supports the maintenance of clinically relevant project-level information in ProMAP as appropriate.Basic QualificationsBA/BS, MA/MS, PharmD, or PhD. Specific field not required, although background should include some pharmaceutical industry and relevant project management experience.Training and/or experience in drug development and clinical research, team leadership, project management and team buildingBA/BS + 8 years, MA/MS or PharmD + 6 years, or PhD + 4 years. Pharmaceutical industry and relevant project management experience is also required. Candidate should have knowledge of drug development and of the tools and methods utilized in developing and maintaining study and project schedules. Experience in clinical research or other areas of the pharmaceutical industry is required. Candidate should have proven leadership and project management capability, and excellent communication, organizational, interpersonal, leadership and presentation skills.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.