Senior Director, Clinical R&D, Inflammation and Immunology
Req #: 16002192
Job Category: Clinical Development
Work Location: Celgene Summit 86 Morris Avenue Summit 07901
Organization: Celgene Corporation
Shift: Day Job
Employee Status: Regular
Job Type: Standard
Job Level: Director
Travel: Yes, 20 % of the Time
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 Senior Director, Clinical R&D in the Rheumatology therapeutic area will be instrumental in supporting the growth of Celgene’s Inflammation and Immunology franchise by helping to build the value of the current products and develop new products. The incumbent will have hands-on responsibility leading the clinical development team for their assigned therapy area (or indication), designing and executing clinical trials, and running phase 2 and/or phase 3
programs. This position offers potential growth opportunities to the right candidate possessing a combination of intellectual and execution skills and a love of the science.
• Define and develop Target Product Profiles
• Design and optimize clinical trial design and to ensure clinical trials meet ethical and regulatory standards.
• Lead Rheumatology Clinical Development programs and interact with other functional areas such as Discovery, Safety, Marketing, Regulatory, Research and other functions.
• Conduct medical review and interpretation of efficacy and safety data from clinical trials.
• Responsible for the quality, coordination, medical accuracy and timeliness of clinical study reports.
• Work with cross functional team members to prepare abstracts, manuscripts and presentations for external meetings.
• Author clinical sections of regulatory documents such as INDs, Investigator Brochures, CTAs, ISE’s, Clinical overviews, Health Authority responses, PSUR, and DSUR.
• Present and discuss data and findings at relevant team, governance, KOL and regulatory meetings.
• May participate as clinical representative on multidisciplinary Project Teams.
• Establish and maintain working relationships with Study investigators, key opinion leaders, academicians, and Celgene Senior managers and department heads across the corporation
• Ensure adherence to GCP/ICH and Celgene Standard Operating Procedure (SOP) standards.
• Maintain clinical and scientific awareness in area of expertise.
• Guide day to day work of Clinical Research Scientists.
• Manage lifecycle requirements and plans for designated indications.
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.
• Minimum M.D. degree and substantial medical/clinical training in the Rheumatology Therapeutic Area.
• Minimum 3-5 years of experience designing, leading and managing clinical trials in the Rheumatology Therapeutic Area.
• Experience in additional therapeutic areas is beneficial.
• Direct industry experience is preferred; substantial experience working on industry-sponsored trials will be considered.
• Understanding of Rheum drug development process.
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, a nd applicable international regulatory requirements.
• Experience in designing Rheum Clinical trial strategies to obtain regulatory approval.
• Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product.
• Ability to develop and evaluate strategies for the clinical development of a designated indication and to critically evaluate outside expert advice.
• Experience in Clinical project planning.
• Experience working on global and complex Clinical trials.
• Experience working effectively in a team/matrix environment.
• Flexibility and learning agility for other therapeutic areas.