Job ID: 13599
Location: Summit, NJ
Full/Part Time: Full-Time
Department: Translational Dev - Clin Pharm - 3613
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
Minimum of a Master’s Degree (life science preferred) with 5+ years industry experience of which 3+ years is in clinical pharmacology.
The Senior Manager, Clinical Pharmacology Trials, is responsible for the day-to-day operational management and minimal scientific input for global Phase 1 clinical pharmacology trials, from generation of protocol synopsis through final clinical study reporting. Excellent organizational, managerial, and interpersonal skills are required. Knowledge of data processing methods and statistical analyses is preferred. The candidate must have good project and time management skills so tight deadlines can be achieved with minimal guidance. The candidate should have the ability to differentiate rate-limiting issues and to effectively communicate the issues to the appropriate parties, offering proactive resolutions. Ability and willingness to work within a matrix environment and ability to function as representative on project teams are required.
Contribute to the planning, managing, implementing, monitoring and reporting of clinical pharmacology studies (US and ex-US) to characterize the safety, tolerance, pharmacokinetics, and pharmacodynamics in healthy volunteers and/or patients.
Track progress of assigned studies/programs and report updates to management. When applicable, assess rate-limiting issues, and apply resolutions as needed in a proactive manner.
Review budgets of assigned studies and interface with internal department representatives to ensure fiscal accountability.
Interact with thought leaders, investigators, internal, external customers, etc., to move studies/programs forward in alignment with departmental and company objectives.
Critically assess and drive the selection of external vendors for various aspects of clinical pharmacology studies.
Conduct all aspects of study management, from study start-up through report finalization.
Conduct on-site monitoring visits in accordance with company SOPs and GCPs, and manage/mentor internal and/or external study-assigned monitors CRAs.
Maintain study-related documentation as per Celgene SOPs and GCP requirements.
Participate in departmental and company-run initiatives to support continuous business improvements.
Author and review abstracts/manuscripts, etc., for presentation/publication at internal/external meetings.
Travel – approximately 25 to 40% which may also include international travel.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
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Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.