Celgene Senior Director, Product Safety Physician 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.
Position: Senior Director, Product Safety Physician
Supervisor: VP, Therapeutic Area Head, Inflammation & Immunology
Department: Global Drug Safety & Risk Management
Key Responsibilities will include, but are not limited to, the following:
General Product Support
Lead safety activities and benefit-risk strategies for assigned Celgene compounds and chair the product Safety Management Team (SMT).
Oversee, prepare, and/or review aggregate safety review documents (such as Development/Periodic 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 emerging from any data source through case-series review, document analysis, safety topic reviews or other means of communication
Lead safety labeling activities for assigned products.
Act as the Safety Subject Matter Expert for input to regulatory product labeling and participate/provide input at labeling working group meetings, CCDS committee meetings and provide regional safety labeling support.
Support the EU QPPV or other regional or local Qualified Person for Pharmacovigilance relative to issues relating to assigned products.
Provide input to R&D publication strategy, publication plan, and ensure safety input to publications and presentations.
Act as the global safety lead for assigned compounds in development and provide safety lead support global submission document 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-focused publication development.
Ensure medical safety review of development update safety reports, annual reports and other periodic safety submissions.
Actively drive safety strategy preparation for pre-NDA meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings.
Act as the safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions.
Provide medical safety, benefit-risk input and approve periodic safety update reports, product renewal submissions, postmarketing study documents and reports, responses to health authority queries.
Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
Lead safety signaling and prepare and/or review reports on safety signals (i.e., Safety Topic Reviews) and ad hoc regulatory responses.
Provide postmarketing safety study guidance to other groups including pharmacoepidemiology group and medical affairs including but not limited to investigator initiated studies, epidemiology studies, non-interventional safety studies.
Ensure safety labeling adequately reflects emerging postmarketing safety profile.
Assist the GDSRM Therapeutic Area Head 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 TA staff and maintain an effective and collaborative product safety team
Support hiring, orientation, management, mentorship, and development of staff.
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 due diligence and potential in-licensing opportunities as requested.
Provide product based liaison for Celgene functions (Legal, BD, Operations, Marketing, etc.).
Support manufacturing quality and provide quality incident medical assessments.
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 such as:
SMT - Safety Management Teams
CSC - Company Safety Committee
PSOB - Patient Safety Oversight Board
TADC - Therapeutic Area Development Committee
DMC - Data Monitoring Committees – internal or external
PRC - Protocol Review Committee
Product Development Team
Clinical Operations Team
Clinical Study Team
Risk Management Team
Relevant Subspecialty Training
OncologyInternal MedicinePharmaceutical Medicine
Relevant Industry Experience
Drug Safety experience
minimum 2 yrs
Pharmaceutical Medicine training
Preferred. Advanced training such as DipPharm Med, ECPM is a plus
Therapeutic Area training
Subspecialty or equivalent experience relevant for the assigned product portfolio and indications, for example:Internal Medicine, Oncology, Hematology, Pediatric Medicine, Pharmaceutical Medicine.
Medical writing & review
Publicationssafety summary of submissionmajor ad hoc review (100+ pages)
Risk Management Plan
Risk Management Team
Liaison with research
Develop search strategy, initiating and reviewing searches
yes and review
Presentation to governance bodies or Health Authorities
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.