Bristol Myers Squibb Company

Associate Director, Safety Science

Location
Celgene, NJ, United States
Posted
Aug 30, 2020
Ref
R1526773
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Key Responsibilities will include, but are not limited to, the following:

General Responsibilities
  • Provides support to LPSP (Lead Product Safety Physician) in activities relating to monitoring and management of unapproved and approved product's emerging safety profile
  • May present at the Safety Management Team (SMT) with support of the LPSPDrafts materials (Slides, etc.) in preparation of Company Safety Committee (CSC) meetings
  • Leads signal detection activities (evaluation and tracking) by conducting review and synthesis of key safety information
  • May lead ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the Lead Product Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile
  • Provides support to LPSPs for Product Quality issue and inquiries from external department (e.g. Legal, clinical, RA, etc.)
  • Provides input and support safety publication strategy


Trial Safety Support
  • Serves as the Lead Safety Scientist for several compounds and may oversee the operational execution of all safety-related clinical trial activities
  • May lead the strategy for surveillance activities, signal assessment, and regulatory safety requests for multiple compounds and/or key registrational clinical trials (in development or investigator-initiated)
  • May oversee and completes study-level activities (as needed): risk/benefit assessment for EU CTAs, protocol and statistical outputs (e.g. tables, listings & graphs [TLGs])
  • Authors or provides content for safety sections of documents such as Investigator's Brochures, Aggregate Safety Reports (PSUR/DSUR), Annual Reports, Standard Risk Language for ICFs, Company Core Data Sheet and Risk Management Plans
  • Provides support for the lead safety physician in the strategy and authoring of integrated submission documents
  • Obtains and reviews integrated safety outputs by analyzing data from the clinical trial and global safety database as well as literature, in conjunction with the lead product safety physician across multiple compounds
  • Assists the lead product safety physician with the management of the product's benefit/risk profile


Post-marketing Support
  • Contributes to development of signal detection strategy with consideration for integrating quantitative data mining methods and qualitative approaches
  • Provides support to LPSP in development of risk mitigation strategies
  • Leads Safety Topic Review development and authorship
  • Leads ad-hoc regulatory safety requests preparation by obtaining and analyzing data from various sources to assist the Lead Product Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile
  • Authors or provides content for safety sections of documents such as aggregate safety reports (PSUR/DSUR), Company Core Data Sheet, Risk Management Plans, and Events of Interest Surveillance Documents
  • Drafts and conduct safety labeling activities for assigned products
  • Performs literature review and QC


Compound Level Safety Support
  • Authors or provides content for safety sections of documents such as Investigator's Brochures, aggregate safety reports (PSUR/DSUR), annual reports, Standard Risk Language for ICFs, Company Core Data Sheet and Risk Management Plans
  • Provides support for the lead safety physician in the strategy and authoring of integrated submission documents
  • Obtains and reviews integrated safety outputs by analyzing data from the clinical trial and global safety database as well as literature, in conjunction with the lead product safety physician across multiple compounds
  • Assists the lead product safety physician with the management of the product's benefit/risk profile


Departmental Activities
  • Leads preparation for regulatory inspections with evaluation of current processes and documentation, and may serve as the SME
  • Liaises with all TA staff and maintain an effective and collaborative product safety team
  • Trains and mentors junior safety scientists and/or other safety staff


Cross-Functional Activities
  • Leads various process improvement and cross-functional initiatives for both Safety Science and GDRSM, including SOPs and Work Practices
  • Leads various process improvement and cross-functional initiatives for both Safety Science and GDRSM, which may include authorship of SOPs and Work Practices
  • Leads interactions with key line functions in support of safety activities between Safety Science and clinical R&D, Biostatistics, Data Management, Trial Management, Medical Affairs, or Safety Information Management


Key Relationships: Department staff, peers and management, Lead Product Safety Physicians, Clinical Operations, Data Management, Clinical Research Scientists, Medical Writing, Case Management / LDSO, Global Medical Affairs, Regulatory Affairs, Clinical Quality Assurance

Governance; Participate and/or provide input to materials and strategies at meetings including but not limited to:
  • SMT - Safety Management Teams
  • DMC - Data Monitoring Committees - internal or external
  • Product Development Team
  • Clinical Study Team
  • Risk Management


Qualifications/Experience

Education: Pharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience

Relevant Industry Experience: At least 6-8 years of relevant pharmaceutical industry experience, with at least 4 years of drug safety experience. Previous experience in Safety or Clinical Development or Operations is required

Key Leadership Behaviors/Competencies: Decision-Making & Change Agility, Conflict Management, Relationship Management, Communication/Writing, Time Management & Prioritization, Results-Drive

Self-Awareness & Perspective, Organization Skill & Political Savvy

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.