Sr. Director, Clin R&D

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.

If you’re interested in changing human health through the bold pursuit of science, Receptos, a wholly owned subsidiary of Celgene, has a dynamic opportunity for a Exec Dir or Sr. Dir, Clinical R&D.   You will have the opportunity to make a positive impact on changing patients’ lives while being a key contributor to the Company’s growing clinical development activities in Neurology and Gastroenterology.  Receptos fosters a culture of innovation, collaboration, and action.   Under the direction of the medical director, clinical development, she/he will collaborate with key internal functions such as clinical operations, data management, regulatory, CMC, as well as external partners and stakeholders such as contract research organizations, consultants, and thought leaders.

• Leads the clinical trial development process for EoE.
• Drives and executes clinical strategy in collaboration with the Clinical Operations team.
• Serve as the Medical Monitor for the ongoing Phase 2 clinical trial and future trials in EoE or other indications as assigned.
• 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 medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources.
• Interacts in collaboration with strategic partners.
• Leads program and protocol development in general - responsible for clinical development plans and study designs.
• Provides input/review study start up documentation, e.g. source data verification plans based on protocol specifications, CRF design.
• 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.
• Participates in the SAE reporting process.
• 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.

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.