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Associate Director, Clinical Trial ManagementPosted by: Regeneron
Posted date: Feb-10-2012
Location: Tarrytown,NY,United States
Oversee and manage all activities related to the conduct of clinical research projects in order to meet deliverables and program objectives. Interact with various internal and external vendors as well as clinical study sites. Periodically travel to assure compliance with protocol and clinical research project objectives. Clinical research is typically cyclical and some periods during the trial cycle are particularly busy, such as study start-up, enrollment, and database cleaning/lock. These periods may require more time, staffing effort and commitment.
Essential Duties and Responsibilities:
· Performs job duties with minimal guidance.
· Delivers high quality program deliverables on time and within budget.
· Manages, tracks, and troubleshoots a series of related trials within a single program.
· Identifies program risks; proactively creates and implements mitigation strategies.
· Has operational expertise and communicates effectively operational needs to ensure goals are met.
· Keeps appraised of all decisions in order to ensure established goals are attainable prior to the consensus to implement.
· Develops work plans, establishes clinical research objectives, assigns tasks and supervises Clinical Trial Managers.
· Maintains schedules (timelines) for overseeing assigned clinical research studies and facilitates decision making in order to adhere to timelines.
· Provides guidance to Clinical Team by establishing clinical research goals that are aligned with established policies and standards for the department and organization.
· Identifies and recommends changes to established practices and policies which affect subordinate resources.
· Directs the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities.
· Recommends additional resources based on need to meet goals and milestones.
· Clinical site management: answers questions from sites and documents interactions, obtains updates, coordinates supplies, manages drug issues, and collects regulatory documents.
· Data Management: interacts with Data Management to ensure that data being collected are accurate, data queries are resolved in a timely manner, statistical analysis plan is developed, and data is transferred to Regeneron as needed.
· CRO management: interacts with CRAs and project manager to ensure sites are being monitored appropriately, data is collected in a timely manner, and study is progressing properly.
· Oversees Internal Aspects of Trial: ensures appropriate paperwork to Regulatory Dept., adequate drug supply, and coordination of sample shipments to sample analysis department.
· External Laboratory, Equipment, and Service Vendors: determines services to be provided and ensures those services are provided according to the study needs and within the budget.
· Interfaces with senior management to report on project and program milestones and to present project needs.
· Communicate operational aspects of studies in each project.
· Assists in preparing scenarios for creative solutions to hurdles.
· Is the point person for information on status of different projects in program.
· Attends appropriate development meetings.
· Provides timely and accurate information to Program Management for program level tracking.
· May have full budgetary responsibilities.
· Includes review, presentation, approval of initial budget and changes to review bodies as appropriate.
· Adherence to budget.
· Manages clinical study site payments and other vendor invoices.
· Writes reports: FDA Annual reports, Investigator Brochure and updates, Clinical Study report, Protocols, and Informed Consent forms. These tasks occur and are needed at least once annually.
· Assignments are given in the form of objectives with little or no process defined.
· May or may not manage lower-level staff (CTMs).
· Bachelor's degree (B.S.) in the Life Sciences Discipline from a four-year college or university (advanced degree preferred).
· Minimum seven (7) years of clinical research experience in the Pharmaceutical industry, preferably in multiple phases.
· Minimum 2 years management experience.
· Phase III Global experience required.
· Experience in the therapeutic area of Cardiovascular and or Pain is a plus
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Regeneron is a fully integrated biopharmaceutical company that discovers, develops, manufacturers, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, which is approved for the treatment of a rare inflammatory condition, Regeneron has completed Phase 3 clinical trials of rilonacept for a new indication and of product candidates EYLEA (aflibercept injection; VEGF Trap Eye) in diseases of the eye and ZALTRAP (aflibercept) (VEGF Trap) in colorectal cancer. EYLEA is currently under review with U.S. and European regulatory authorities. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis, pain, cholesterol reduction, allergic and immune conditions, and cancer.
Disclaimer: Effective immediately, Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the Internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com