Sr Director Clinical R&D (MD), Inflammation & Immunology - Veteran's Welcome
- Aug 31, 2017
- Healthcare : General Healthcare
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 Sr. Director Clinical R&D will be instrumental in supporting the growth of the Company'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 development strategies, 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.
Representative responsibilities will include:
• Define and develop Target Product Profiles and Integrated development strategies.
• Design and optimize clinical trial design and to ensure clinical trials meet ethical and regulatory standards.
• Lead 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.
• Minimum M.D. degree and medical/clinical training, in an Inflammatory & Immunology Therapeutic Area.
• Minimum 3-5 years of experience in designing development strategies and leading and managing clinical trials in I&I Therapeutic Area.
• Experience in basic, translational science beneficial.
• Direct industry experience is preferred; substantial experience working on industry-sponsored trials will be considered.
• Understanding of I&I drug development process and the complexities of integrated drug development.
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
• Experience in designing I&I Clinical trial strategies to obtain regulatory approval.
• Strong scientific/technical skills, including knowledge of cell biology, toxicology, clinical pharmacology and statistics. Excellence in clinical trial methodology.
• 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.
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