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.
- Influence the company’s global strategy to integrate epidemiology into the development process and post-marketing safety.
- Evaluate the overall R&D therapeutic area strategy globally in order to assist company in evaluation of the research portfolio.
- Improve design of clinical research programs, anticipate pre and post-approval clinical safety issues, and contribute to their successful investigation and management.
- Serve as Celgene’s epidemiological expert in meetings with Senior Management, Regulators, KOLs.
- Represent epidemiology on cross-functional teams including Safety Management Teams, Regulatory submission teams.
- Expand market awareness to improve the commercialization of Celgene products.
- Strategic and management responsibility for one or more safety epidemiologists.
- Strategies for and delivery of epidemiologic programs, including external database analyses, post-authorization safety & efficacy studies.
- Epidemiology components of R&D documents, including global regulatory submissions, Developmental/Risk Management Plans (including REMS).
- Safety Topic Review background epidemiology.
- Evaluation of signal detection methodologies.
- Key, high value Presentations and Publications.
- Product development.
- Epidemiological / analytic methodologies.
- Depth regarding disease natural history in areas such as oncology / hematology/inflammation/immunology.
- International Drug Safety Regulations.
- Organisation and planning.
- Communication (written & oral).
- Team work.
- Information analysis skills.
- Data representation skills.
- Staff Management
- Ph.D. in epidemiology
- MD/PhD combination optional
- Ten (10) years relevant experience, including training.
- Six (6) years industry epidemiology experience.
- Drug safety experience required.
- Strong publication track record.
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 non-discrimination 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.
Req ID: 15001961
Primary Location: United States-New Jersey-Berkeley Heights
Job: Drug Safety
Organization: Celgene Corporation
Employee Status: Director
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 5 % of the Time
Job Posting: 2015-11-01 00:00:00.0
Clinical Research, Database, Epidemiology, Finance, Healthcare, Hematology, Immunology, Law, Legal, Management, Manager, Medical, Medical Research, Medical Technologist, Oncology, Product Development, Public Health, R&D, Research, Risk Management, Technology
- Apply online at: http://www.hirelifescience.com/senior-director-epidemiology-job/berkeley%20heights-nj-11111-578398/?p=p&submission=2