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.
Located within Celgene's Global Drug Safety and Risk Management department, this Executive Director has global responsibility and safety oversight for all new drugs in Celgene's early development ematology/Oncology pipeline. Manages staff of physician global safety leads who are assigned to global development projects and serve as the safety representative on the cross-functional development teams. Responsible for setting safety strategy for these
global projects and identifies resources and tools necessary to facilitate safety assessment and to implement necessary risk management initiatives. Interfaces with key high-level internal and external stakeholders, including company safety committee, and approves regulatory report/submissions. Independently addresses the most complex safety issues as key decision–maker.
• Workload management and resource planning for GDSRM's support of Hematology/Oncology global development teams and projects
• Oversight of safety management teams ensuring thorough and consistent approach to the review of safety data emerging from clinical trials
• Training and mentoring of physician safety leads
• Oversee quality of all safety document deliverables
• Oversee safety role in facilitating reviews done by internal and external DMCs
Clinical Trial Safety:
• Sets safety strategy that allows for successful IND filings and initiation of first in human studies
• Oversight of all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports
• Oversees development of core safety information for new compounds
• Sets the strategy and reviews and approves key filing documents including ISS, SCS, and risk management plan
• Provide major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in Celgene's studies
Other Key Responsibilities:
• Collaborate with other functions in and stakeholders, such as clinical, regulatory, medical and other functions to increase the overall profile of GDSRM
• Represents GDSRM in relevant Hematology/Oncology forums, both internal and external.
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 of MD (or international equivalent) plus accredited residency
• Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred
• Ten (10) years pharmaceutical/biotechnology industry experience, of which at least five (5) should be in a safety role, with experience in hematology or oncology
• Previous line/matrix management experience
• Experience in addressing and managing safety issues in pre-approval environment
• Clinical knowledge of therapeutic area patient populations and drug class
• Demonstrated knowledge and understanding of drug development
• Mastery of global regulatory requirements for pharmacovigilance and drug safety
• Expertise in analyzing clinical trials from a safety perspective