Celgene Senior Dir, Clinical Development in San Diego, California

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.

Senior Director, Clinical Development

Status: Exempt

Reports to: VP, Clinical Development

Responsibilities:

  • Leads the clinical trial development process for products in the gastroenterology portfolio.

  • Drives and executes clinical strategy in collaboration with the Clinical Operations team.

  • Collaborates with the safety department to monitor the safety of assigned clinical trials and participates in the SAE reporting process.

  • Leads program and protocol development in general - responsible for clinical development plans and study designs.

  • Provides input/review on study start up documentation, e.g. source data verification plans based on protocol specifications, CRF design and vendor integration plans.

  • Plays an active role in investigator meetings and other study implementation meetings.

  • Leads review of study data, working closely with biostatistics and data management.

  • Leads data interpretation and presentation to Senior Management.

  • Provides oversight to and interaction with the clinical and safety personnel from the clinical CRO.

  • Leads preparation of clinical sections of all relevant regulatory filings (IND, study reports, NDA, etc.).

  • Serves as the external face of the program to KOLs, clinical advisory boards, 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 the technical resource for issues raised by internal and external collaborators, investigators, consultants and contract resources.

  • Interacts in collaboration with strategic partners.

  • Works closely with Medical Affairs in the development of publications, abstracts, and presentations.

  • May be responsible for program planning and compliance with inspection readiness.

  • Supports business development activities, including due diligence activities.

  • Other responsibilities as assigned.

Requirements:

  • MD degree. Advanced training in gastroenterology preferred with at least 5 years clinical development experience.

  • Experience with inflammatory bowel disease and/or eosinophilic esophagitis a plus.

  • In-depth knowledge and thorough understanding of FDA, EU, 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.

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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.