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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 relevant R&D roles and significant experience in related therapeutic area

• Extensive working knowledge in the drug development process, along with expertise in one or more of the relevant areas (e.g. clinical, regulatory, program management, project planning and management, medical)

• Experience navigating cross-functional teams (matrix) or complex organizations successfully

• Demonstrated ability to constructively influence peers and senior leaders across R&D

• Working knowledge of regulations in the Pharmaceutical industry (US and Global preferred)

• Demonstrated ability to effectively collaborate across geographic and functional boundaries (e.g. early development, R&D, disease strategy teams, marketing, access, etc.) and building strong external relationships

• Ability to navigate through a complex and dynamic healthcare environment

• Abreast of scientific issues as they impact business development and strategic planning

• Success in situations requiring rigorous, analytical problem solving and the ability to determine scientific opportunity and commercial targets

• Broad understanding of domestic and international issues relative to the pharmaceutical industry

• Proven agility in prioritizing and navigating competing demands

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1582342

Updated: 2024-06-26 01:20:56.758 UTC

Location: Madison-NJ

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.