Bristol Myers Squibb Company

Head, Pre-Approval Access Operations (PAA)

Princeton, NJ, United States
Sep 02, 2020
Required Education
Bachelors Degree
Position Type
Full time
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.

Purpose/Objective of the Position:

Provide senior level operational oversight and leadership for the Pre-Approval Access (Early/Expanded Patient Access) process and execution of programs across assigned assets.

Key Responsibilities and Major Duties
  • Senior-level clinical operational leader who drives and provides direct oversight of all operational components for large-scale global Pre-Approval Access (PAA) strategy & operational team using strong project management, leadership, collaboration and organizational skills. Excellent communication skills required.
  • Serve as Pre-Approval Access subject matter expert for Global Development Operations and key interface with Commercial, Medical and external stakeholders.
  • Accountable for the PAA program to support the diverse portfolio of work across BMS. Proactively addresses and manages risks and issue escalation.
  • Actively contributes to the early development of clinical operational strategy as it pertains to types of Pre-Approval Access programs permissible by region/market.
  • Accountable for collaboration and standards of the PAA programs.
  • Represents GDO Strategy organization as a core member within the PPA and ACCESS program teams
  • Drives the development of PAA Policies, Process, Governance and execution of operational support on a global basis
  • Inclusive in communicating strategy and decision making across a matrix team.
  • Drives continuous process improvement initiatives to support PAA while demonstrating critical thinking to execute against the new process(s)
  • Provides training support (or in collaboration with the training team) of the operationalization requirements of PAA Policies and Procedures

Supervisory Responsibility:

Provides Matrix Management oversight across all operational support team(s).

Minimum requirements:

> 13 years of direct experience leading and managing global clinical trial program(s) (inclusive of 3+years in a senior leadership position directing the operations of a global team); track record of developing and mentoring junior colleagues; PAA experience is required.

Key Stakeholders/Contacts (may not be comprehensive list):

Medical Affairs Team(s), Commercial ACCESS teams, Corporate Giving, Field Medical, Country Medical Heads/Directors, Development Team (DT), Surveillance Medical Team (SMT), Global Regulatory Sciences and Biometrics (GRS+B), All GDO Functional Groups, Clinical Supply Operations (CSO), Global Quality and Regulatory Compliance (GQRC), External Thought Leaders, External Vendors.

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.