Associate Director, Clinical Trials

Description

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., Associate 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; establishing and managing contracts and budgets 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 may prepare departmental standard operating procedures, working procedures and templates. This role is also responsible for tracking and reporting budgets and timelines for clinical programs.

This position requires a proven track record of increasing responsibility in clinical operations, and successful management of clinical research and support personnel, departmental budgets and timelines in the pharmaceutical/biotech industry.

Experience with large, complex late stage global clinical development programs required. NDA filing and therapeutic experience in a related field highly desired.

Major Responsibilities:

• Evaluate potential contract research organizations (CROs), vendors and other service providers for use in Receptos clinical studies.
• Ensure qualification of CROs, vendors and service providers in accordance with Receptos SOPs.
• Supervises Clinical Trial Managers (CTMs) and/or Clinical Research Associates (CRAs).
• Manage vendors providing the operational functions of Receptos clinical programs.  Participate in functional guidance, training, education and evaluation of vendors personnel.
• Supervise the activities of CROs, contractors and other vendors as they are related to the clinical programs.
• Ensure screening and evaluation of potential Investigators to ensure compliance with regulatory and corporate requirements.
• Supervise negotiation of Investigator agreements and grants appropriate to the clinical programs.
• Ensure review and approval of written reports of all site monitoring visits prepared by CRAs to ensure they are completed in a timely fashion and according to Federal regulations, GCP and SOPs.
• Ensure maintenance of essential documents associated with Receptos clinical trials, in accordance with applicable regulations and international guidance’s.
• Participate in corporate committees, task forces, technical or business meetings as requested.
• Ensure timely and appropriate response to clinical investigator site issues or other study management problems.  Ensure maintenance of documentation in appropriate reports of all communications, particularly those in which patient or protocol issues are discussed.
• Prepare communication and status reports to provide updates/information to senior management.
• Direct clinical operations activities in preparation of interim analyses, clinical study reports, annual reports and other clinical documents.
• Demonstrate mastery of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials.
• Develop and maintain departmental standard operating procedures (SOPs) in collaboration with Clinical Development, Regulatory Affairs and Quality Assurance.
• Represent Receptos in a professional manner; establish and maintain good relationships with Investigators, advisors, other study personnel, clients and vendors.
• Attend seminars, Investigator meetings, project team meetings, educational conferences/training sessions, etc.
• Other duties as assigned.

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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.