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 primary role of the Receptos, Inc., Senior Director, Clinical Operations, is to coordinate, manage and supervise operational activities associated with clinical development programs, including: maintenance of essential study documentation, dissemination of key information to clinical advisors, CROs and ancillary vendor partners and participating investigators; oversee contract and budget process with clinical investigators and clinical trial service providers; preparing clinical trial documents (e.g., protocols, investigators brochures, site operations manuals) and; ensuring that these activities are conducted in accordance with all applicable regulations, and ICH and GCP guidance standards. In addition, this individual will ensure preparation of departmental standard operating procedures, working procedures and templates, and is also responsible for tracking and reporting budgets and timelines for clinical programs.
This position requires a minimum of 15 years of experience in positions of increasing responsibility in clinical operations, and a proven track record of successful management of clinical research and support personnel, departmental budgets and timelines in the pharmaceutical/biotech industry.
Experience with late stage global clinical development required. NDA filing and therapeutic experience with auto-immune mediated diseases highly desired.
Knowledge, Skills and Abilities Required:
#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.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.