Manager Clinical Safety Strategy & Solutions, Global Pharmacovigilance & Epidemiology

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.

The Clinical Safety Strategy and Solutions (CS3) Manager/Lead is accountable for implementing and facilitating the global Clinical Safety Program (CSP) process flows for the purpose of supplemental safety data collection, review and analysis of events of special interest (and laboratory abnormalities) across a compound program(s). Leads and supports initiatives within ESSA and GPVE towards offering solutions to key safety processes and analytic enhancements.

Key Responsibilities and Major Duties

• Independently, actively leads and drives CSP activities with internal and external colleagues and partners so that the program strategy and scope, inclusive of protocols across the assigned compound program(s), are fulfilled.

• Proactively and closely collaborates with Global Pharmacovigilance & Epidemiology (GPV&E), Global Regulatory Strategy (GRS), Global Clinical Operations (GCO), Clinical Development, as well as other key functions including Global Biometric Sciences (GBS), and Global Data Management to ensure that CSP activities are aligned with overall company and departmental standards and goals.

• Medically collaborate and ensure that CSP strategy complements and ties directly into the overall safety surveillance and risk management strategies (REMS, RMP) for the compound. This requires ongoing interactions with Medical Safety Assessment Physicians, Epidemiologist, Medical Review Safety Physicians, and Medical Monitors.

• Works collaboratively with program and protocol team colleagues to successfully execute CSP-related activities for the compound program. This includes, but is not limited to, tracking, reporting, querying, follow up, etc., across protocols.

• Oversees and manages the activities of staff assigned to specific CSP support responsibilities and provides appropriate coaching and performance feedback.

• Responsible for identifying reported qualifying events through J-Review/Spotfire/MedDRA reports and medical consultation and accountable for the appropriate tracking of requests/discrepancy distribution and CRF completion.

• Contributes to the development of the CRF and database in accordance with data management principles and in collaboration with data specialist, protocol data managers, database designers, statisticians, and programmers.

• Proactively collaborates with Data Manager/Specialist to develop CSP lock dates that are consistent with team strategy and main CRF/database lock dates and ensures that all deadlines/locks are met.

• Acts as an expert of knowledge for all CSP activities, including Foundation Setting, Launch, Data Cleaning, and Medical Review, and resolves issues independently or escalates to appropriate personnel. Contributes to establishment of best practices through ongoing coaching, training, and feedback.

• Drives medical exploratory review meetings with key project team members to initiate and formally request the development of J-Review/Spotfire/SAS reports that support the utility of data, either internally or externally.

• Facilitates the CSP responsibilities as it relates to handoffs and working partnerships with Strategic CRO partners, Alliance/Development Partners, and other external academic, laboratory, and external review partnerships which are involved with the safety assessment.

• Addresses regulatory compliance implications of CSP and other initiative processes and adjustments and ensures alignment with existing SOPs, existing project specific documents (including Protocol, Analysis Plan, Monitoring Plan, Data Review Plan, and Transfer of Obligations with CROs, etc.)

• Participates in larger departmental or divisional initiatives. Makes recommendations and significant contributions on process improvements/enhancements to CSP and other departmental initiatives. In collaboration with AD/D-CS3 identifies, solves, and communicates global CSP issues to the wider organization.

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Supervisory Responsibility / Functional Management: NA. Some coaching and mentoring, as applicable.

Key Stakeholders/Contacts: Participates in Medical Surveillance Team (MST) meetings and various Clinical Operations meetings either regularly or as needed. Communicates with internal and external (Investigative Sites, CROs, Alliance and Development Partners) to ensure adherence to CSP global guidances, training, data collection and cleaning, medical review, exploratory and validated reports and analyses. Key partnerships with MSAP (Medical Safety Assessment Physician, MST Chair), MRSP (Medical Review Safety Physician), Safety Scientist and Epidemiologist within GPVE.

List of minimum requirements

• Degree/Certification/Licensure BA/BS Degree or RN

• Experience - Responsibility and minimum number of years 6 or more years experience in clinical research, with minimum of 3 years of that experience at a pharmaceutical company or CRO, including participation in pharmaceutical safety reporting.

• Competencies - knowledge, skills, abilities, other

• Experience working in clinical operations or safety surveillance role, demonstrating knowledge of project, protocol, site, data management, clinical/medical review, and signal detection and assessment.

• Extensive knowledge and understanding of the conduct and management of international clinical trials, particularly data collection processes from both clinical and data management perspectives.

• Established experience working in a team environment within a matrix organization. Works well across organizational, functional, and geographic boundaries to achieve company goals.

• Excellent oral, written, and interpersonal communication skills.

• Demonstrated attention to detail and strong organizational skills.

• Well-developed project management and leadership skills, including prioritization methods.

• Experience with leading teams and providing direction and guidance to team members.

• Knowledge and understanding of safety surveillance, risk management, and signal assessment capabilities and appreciation of overall R&D organizations (e.g., how they operate, key business drivers, etc.)

• Strong knowledge of safety reporting, medical conditions/diseases, ICH/GCP Guidelines, and REMS/RMP.

• Software that must be used independently and without assistance (e.g., Microsoft Suite)

• Working knowledge of computer applications including Microsoft Office Suite, Oracle based systems, Trial Management systems (Oracle Clinical, Medidata RAVE), electronic data capture, MedDRA library, AWARE safety database, Spotfire and J-Review.

Working Conditions

• Travel Required (nature and frequency) Per business need