Associate Director, Clinical Safety Strategy & Solutions- Global Pharmacovigilance & Epidemiology

Summary

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.

Accountable for leading the global process development and implementation of the Clinical Safety Program (CSP) within GPVE, including progressive integration to additional compound teams. Serves as a key conduit and team leader in effectively communicating CSP framework and functionally aligning as appropriate with departments internal and external to GPVE, including Global Regulatory Strategy (GRS), Global Clinical Operations (GCO), Clinical Development, Global Biometric Sciences (GBS), Clinical Data Management and other relevant functions. May or may not include functional management. Leads and supports initiatives within ESSA and GPVE towards offering Solutions to key safety processes and analytic enhancements.

Key Responsibilities and Major Duties

Leads and directs the global expansion and scale-up of CSP within GPVE (for the collection, review, and analysis of supplemental safety data around events and lab abnormalities of special interest) for the purpose of signal assessment/evaluation and overall safety surveillance.

Proactively and closely collaborates with GPVE, GCO, and Clinical Development as well as other key functions including GBS, Data Management, and GRS to ensure that CSP activities are aligned with overall company and departmental standards and goals.

Leads and drives the execution and integration of CSP into various compound teams by maintaining a high performance CSP team and collaborating with Clinical Development, Regulatory and Clinical Operations in the development of strategic plans and implementation of CSP process.

Ensures timely operational execution of CSP deliverables in support of key GPVE safety and development objectives for compound teams engaged in the CSP process.

Ensures proper alignment and integration with external partners (Investigative Sites, Strategic CROs, Alliance and Development Partners, etc.) and supporting organizations to establish and maintain development, Clarification, and standardization of CSP processes and the role/responsibility of CS3 Team.

Assures CSP and other initiative process development and improvements are aligned with organizational compliance and procedures are executed with highest integrity and in accordance with regulatory and GCP quality and company SOPs.

Improves quality, efficiency, and productivity of CSP and other ESSA/GPVE initiatives through the implementation of new solutions of systems/processes, alignment with existing BMS processes, and adherence to BioPharma behaviors through cross-functional collaboration.

Demonstrates and shares technological expertise and understanding of the business process implications of essential computer applications, champions their use and application, and makes recommendations regarding upgrades relevant to content and timelines.

Manages functional excellence and career development of direct reports or mentees, if applicable. Provides ongoing coaching, training, performance and career counseling, and feedback, and appropriately allocates and fully leverages available resources on existing project teams and assesses CS3 resource needs and responds appropriately to secure additional support staff.

Key Stakeholders/Contacts

Key partnership with MST Chair (MSAP-Medical Safety Assessment Physician), MRSP (Medical Review Safety Physician), Epidemiologist within Medical Surveillance Team (MST) of various compound(s). Serves as a key conduit and team leader in effectively communicating CSP strategy and framework and functionally aligning as appropriate with departments internal and external to GPVE, including GRS, GCO, GBS, and development/alliance/strategic partners.

Requirements/Experience

• BA/BS required with 8-10 years experience in clinical research, with minimum of 4 years of that experience at a pharmaceutical company or CRO, including participation in pharmaceutical safety reporting
• Demonstrated ability to affect organizational change and to get results supporting company objectives under complex and possibly ambiguous conditions.
• Demonstrated ability to work and manage effectively in a team environment within a matrix organization as project team leader. Works well across organizational, functional, and geographic boundaries to achieve company goals.
• Knowledge of R&D development organizations (e.g., how they operate, key business drivers), as well as formal and informal structures and governance processes (how to get things done).
• Extensive and broad knowledge and understanding of the conduct and management of international clinical trials, in particular data collection processes from both clinical and data management perspectives.
• Excellent oral, written, and interpersonal communication skills. Proven ability to effectively communicate with and influence individuals at all levels of the organization.
• Strong project management, leadership, and organizational skills, including prioritization methods and attention for detail.
• Demonstrated ability to lead teams and provide strategic planning, direction, and guidance to team members.
• Extensive knowledge of safety reporting, medical conditions/diseases, ICH/GCP Guidelines, and risk management (REMS/RMP).
• Software that must be used independently and without assistance (e.g., Microsoft Suite)
• Microsoft Suite, Oracle based systems, Trial Management systems (Oracle Clinical, Medidata RAVE), electronic data capture, MedDRA library, AWARE safety database, Spotfire and J-Review.