Clinical Development Lead Pediatric Hematology, Oncology and Cell Therapy

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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Position Summary

The Clinical Development Lead Pediatric Hematology, Oncology and Cell Therapy sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development.  The Clinical Development Lead (Pediatrics) will serve as primary partner for asset development teams in shaping pediatrics strategy and development plans, consulting with other functional SMEs as needed.   The Clinical Development Lead (Pediatrics) will ensure a cohesive pediatrics approach across hematology, oncology and cell therapy.  The Clinical Development Lead (Pediatrics) is part of the Pediatrics Center of Excellence (CoE).

Roles & Responsibilities:

• Shapes the vision and growth strategy, in partnership with Development Program leads, for all oncology pediatric assets entering full development through the asset life-cycle for both BMS-sponsored development programs and for development projects with external collaborators
• Serves as dedicated point of reference on Pediatrics Development for development teams, study teams, and senior leadership
• Provides strategic advice to development teams based on the competitive landscape to support the regulatory acceptance of the pediatric plan, and reviews pediatrics outputs against the Pediatrics strategy and regulatory expectations
  • Provide guidance on the adequate timing for Pediatric development based on EU / US regulatory requirement and Adult development.
  • Participate in the pediatric kick off meeting, provide guidance on strategy and over the course of the development of the pediatric participate as needed.
  • Review all the Pediatric regulatory documents (PIP, PSP, PPSR/WR) and pediatric protocols
  • Provide scientific, regulatory, clinical and commercial Pediatrics insights to support the team in assessing business opportunities
  • Engages in regular, two-way communication with Development Teams on evolving program risks, implications of changes in the competitive landscape, and progress toward key milestones
• Provides point of contact and supervision for clinical trial physicians working on across oncology asset teams in late development (dotted lines)
• Coordinates pediatric projects across oncology, including both BMS sponsored, as well as investigator sponsored research projects and trials, and compassionate use programs
• Educates and engages matrix team members around the Pediatrics vision
• Liaises with and provides point of contact for Development Program Leads in oncology early development
• Supports across portfolio activities in line with Clinical Excellence, including e.g. Protocol Review Committee, and Quality and Compliance leadership
• Ensures asset level pediatrics strategies are aligned with oncology and company Pediatrics strategy and vision
• Drives portfolio value through an understanding of the interdependencies between both adult and pediatric development plans and an ability to advise on strategic trade-offs
• Member of the Pediatrics CoE and primary report to PedCoE
• Creates tools and trainings to empower teams and drive consistency within and across Therapeutic Areas
  • Drives initiatives to further the company Pediatrics strategy
  • Collaborates with other members of the Pediatrics CoE to share best practices and enable standardization
• Builds and maintains collaborative relationships with external stakeholders (Opinion Leaders, Strategic Alliance Partners, Patient Advocacy Leaders, Health Authorities)
• Supports Investor Relations and Public Affairs in managing external BMS communications, as needed

Requirements:

• MD
• A minimum of 7 years in the pharmaceutical industry, Health Authorities and/or academic experience, with proven progression in rele