Associate Director Safety Science

Profile

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 Responsibilities

Provides support to LPSP in activities relating to monitoring and management of Product's emerging safety profile

Leads the logistics/coordination of Safety Management Team (SMT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, minutes/communication and preparation of materials, in support of the LPSP

Drafts 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

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

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

Previous experience in Safety or Clinical Development or Operations is required

Drug Safety Experience

At least 4 yrs

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

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.

Company info

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