Manager, Clinical Pharmacology Trials
Other Locations:US- NJ- Summit West
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 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. The candidate must have good project and time management skills to allow aggressive deadlines to be met. The candidate must be familiar with GCPs and ICH guidelines. The candidate should have the ability to identify potential rate-limiting issues and to effectively communicate the issues to the appropriate parties. The ability to work within a matrix environment, knowledge data processing methods, and basic budget and contract information are preferred.
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 and report updates to management, identify rate-limiting issues, and propose solutions as needed in a proactive manner.
Review budgets of assigned studies and interface with internal department representatives to ensure fiscal accountability.
Interact with investigators, internal customers, external customers, etc., to progress studies forward in alignment with departmental and company objectives such as initiation visits, monitoring visits, budget meetings, study team meetings, etc.).
Participate in the assessment and selection of external vendors for various aspects of clinical pharmacology studies.
Conduct all aspects of study management, from study start-up through report finalization.
Participate in the site evaluation visits and on-site monitoring visits in accordance with company SOPs and GCPs, and direct internal and/or external study-assigned monitors (eg, CRAs).
Maintain study-related documentation as per Celgene SOPs and GCP requirements.
Participate in departmental and company-run initiatives to support continuous business improvements. Participate in authoring and reviewing abstracts/manuscripts, etc., for presentation/publication at internal/external meetings.
Travel required - approximately 25 to 40%.
Education: Bachelor degree in life sciences or a Master's Degree (life science preferred).
Industry experience: 7 or more years with a bachelor's degree, or 5 or more years with a master degree, and clinical pharmacology trial experience of 3 or more years, or assessed on an individual basis as per management.
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.
#LI-POSTCelgene 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.