Bristol Myers Squibb Senior Director, Lead Project Safety Physician in Summit, New Jersey
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
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
5 yrs Drug Safety experience
Minimum 2 yrs Pharmaceutical Medicine training
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
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.