Celgene Senior Director, Hematology/Oncology Global Drug Safety and Risk Management in Summit, New Jersey
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.
General Product Support
Lead safety activities and benefit-risk strategies for assigned Celgene compounds and chair the product Safety Management Team (SMT)
Serve as safety lead on global development project teams for assigned Celgene compounds
Oversee, review, and approve aggregate safety review documents (such as Development Safety Update Reports) and safety sections of relevant clinical trial documents (e.g., protocols, Investigator brochures, informed consent forms)
Lead team in evaluation of signals from clinical trials data and document analysis and review through safety topic reviews and other means of communication
Provide input to R&D publication strategy, publication plan, and ensure safety input to publications and presentations
Act as the safety lead for assigned compounds in development and support global submission documents production and review
Lead medical safety development and execution of benefit-risk management strategies for assigned products
Provide safety input to clinical development plans, study protocols, amendments, investigator brochure, statistical analysis plans, informed consent, clinical study reports, responses to health authority or EC/IRB queries.
Lead development of safety risk language, risk management plan, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, safety focus paper development.
Ensure medical safety review of development update safety reports, annual reports and other periodic safety submissions.
Actively drive benefit-risk strategies for pre-NDA meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings.
Assist Exec Dir, HemOnc, in developing and maintaining state-of-the-art pharmacovigilance processes and procedures within Celgene R&D, and GDSRM
Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates
Assist the team and senior management in all forms of issue management and crisis management
Liaise with all Hem/Onc staff and maintain an effective and collaborative product safety team
Provide input to strategic plans for safety differentiation of Celgene products
Co-ordinate training to Celgene employees on product safety profiles/issues
Provide input to potential in-licensing opportunities as requested
Provide product based liaison for Celgene functions (Legal, Business Development, Operations, Marketing, etc.)
Develop communications of safety data & interpretation to Celgene and external parties, globally
Medical Safety Reviewers
Clinical Development Physicians
Risk Management scientists
Global Medical Affairs
Participate and/or provide input to materials and strategies at meetings including but not limited to
SMT - Safety Management Teams
CSC - Company Safety Committee
DMC - Data Monitoring Committees – internal or external
PRC - Protocol Review Committee
Product Development Team
Clinical Operations Team
Clinical Study Team
Risk Management Team
Subspeciality - Preferred
Relevant Subspeciality Training
HematologyInternal MedicinePharmaceutical Medicine
Relevant Industry Experience - 5 years
Drug Safety experience - minimum 2 yrs
Medical writing & review
PublicationsSafety summary of submissionMajor ad hoc reviews (100+ pages)
Risk Management Plan - finalized
Safety Management Team - leader
Presentation to governance bodies or Health Authorities - yes
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.