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VP, Clinical Development

Req #: 1800238
Location: San Diego, CA US
Job Category: Medical
Work Location: 3033 Science Park Road Suite 300 RCPTSD 92121
Organization: Receptos, Inc.
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- CA- San Diego- Science Park

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.

  • Leads all the clinical development programs including UC, CD, EoE, and other neurologic indications (e.g., pediatric MS, CIDP, ALS, stroke).
  • Leads the clinical strategy design in collaboration with the CMO, regulatory affairs, and commercial
  • Responsible for the design of all clinical trials and protocol development for the programs
  • Serve as the Medical Monitor for the ongoing Phase 3 clinical trials and future trials in UC, CD, MS and other neurologic indications
  • Provides oversight to and interaction with the medical monitors and safety personnel from the clinical CROs
  • Leads preparation of clinical sections of all relevant regulatory filings (IND, IB, CSRs, NDA, etc…)
  • Serves as the external face of the program to KOLs, clinical advisory boards, DSMB, investigators, vendors/CROs and clinical sites
  • Interacts with advisory board members to assure implementation of the latest clinical thinking and guidelines into clinical development plans
  • Serves as therapeutic area expert for clinical and scientific issues raised by internal and external collaborators, investigators, and contract resources
  • Plays an active role in investigator meetings and other study implementation meetings
  • Leads review of clinical trial data, working closely with biostatistics and data management, and CRO partners
  • Leads data interpretation and presentation to Senior Management, investors and potential partners
  • Works closely with Medical Affairs and the Steering Committees on the development of publications, abstracts, and presentations
  • Hire appropriate personnel to meet the demands of the above

Requirements:

  • MD or MD/PhD.  Board Certified / Board Eligible in neurology, and/or relevant clinical experience in neurology required.
  • 10-12+ years’ experience in clinical development in pharmaceutical or biotech industries, including cross-functional leadership and prior management experience
  • Experience in the neurology therapeutic area required; specific experience in late stage MS clinical trials a strong plus
  • NDA filing experience required
  • In-depth knowledge and thorough understanding of FDA, EMA, and global regulations, ICH guidelines, and GCPs that govern clinical research
  • Effective leadership, management, strategic, technical, analytical, problem-solving and negotiation skills
  • Outstanding presentation, written and oral communication skills
  • Strong leadership profile with executive presence
  • Highly collaborative with team orientation; flexible in personal interactions at all levels of the company
  • Ability to work proactively and effectively, with exceptional creative problem solving skills
  • Decisive, action-oriented, “hands-on” individual, responsible for his/her own work; willing and able to self-assign duties as appropriate
  • Comfortable working in a fast-paced, entrepreneurial environment
  • Flexible, well-organized and able to manage a high-volume workload and numerous projects simultaneously under deadline pressures
  • Comfortable and capable of multi-tasking both internally-driven and externally-directed projects

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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.
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About Celgene

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.

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