Manager, Clinical Pharmacology Trials Summit United States,
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Manager, Clinical Pharmacology Trials, is responsible for the day-to-day operational management and general scientific input for global Phase 0/1 clinical pharmacology trials, from protocol writing through final clinical study reporting. Excellent organizational, managerial, and interpersonal skills are required. Experience in managing various types of clinical pharmacology studies is essential. Understanding of basic pharmacokinetic principles, data collection methods, and statistical analyses is preferred. The candidate must have strong project and time management skills and be able to function with some/minimal guidance. The candidate should have the ability to identify rate-limiting issues, anticipate problems, and to effectively communicate with the appropriate parties, offering proactive resolutions. Ability and willingness to work within a matrix environment and ability to function as representative on project teams as required.
Education and Experience:
- Bachelor s Degree (life science preferred) with biopharmaceutical industry experience of 10 or more years, and clinical pharmacology experience of 7 or more years.
- Master s Degree (life science preferred) with biopharmaceutical industry experience of 6 or more years, and clinical pharmacology experience of 3 or more years.
- Manage clinical pharmacology studies (US and ex-US) and individual study teams.
- Track progress of assigned studies/programs and report updates to management. When applicable, assess rate limiting issues, and apply resolutions in a proactive manner.
- Review study budgets, contracts, and work orders.
- Interact with thought leaders, investigators, internal, external customers, etc., to move studies/programs forward in alignment with departmental and company objectives.
- Evaluate external vendors and potential clinical sites for various clinical pharmacology studies.
- Conduct all aspects of study management, from study start-up through report finalization.
- 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 required approximately 25 to 40%.
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.
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