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About the Role

The Clinical Development Program Leader (CDPL), Hematology is responsible for setting the clinical development strategy for assets or indications within the global Clinical Development organization. This role involves supervising Clinical Development Leads, overseeing above disease/indication strategy, and supporting the transition of assets from early to late-stage development. The CDPL will also contribute to across-portfolio activities and serve as a core member of the Therapeutic Area clinical development leadership team.

Responsibilities

Create and communicate a vision for designing, conducting, and executing innovative clinical development plans.
Supervise the development, monitoring, analysis, and interpretation of clinical trials.
Supervise and have accountability for the clinical components of regulatory filings.
Contribute to overall strategy for specific disease/indications while ensuring a franchise overall portfolio view.
Provide strategic insights into clinical development plans.
Lead search and evaluation activities on business development due diligence efforts.
Advise the strategic transactions group.
Create a Clinical Development strategy to develop programs beyond commercialization and launch and into lifecycle management.
Lead and develop a group of Clinical Development professionals, ensuring scientific and technical excellence.
Recruit, develop, and retain strong talent.
Mentor talent/staff.
Establish an effective and ethical culture that encourages teamwork, peer review, promotes cooperation, and provides a supportive culture.
Develop a culture that values diversity of thought, supports coaching, fosters accountability and integrity, and supports process excellence and continuous improvement.
Oversee team budget and headcount.
Work closely with colleagues in BMS Research, Development, Regulatory, Medical, Commercial, and other key functional areas globally.
Build relationships with thought leaders, physicians, and patient advocacy groups externally.
Partner and interact with colleagues from Research and Early Development to assure a seamless transition into late-stage development.
Participate in governance ad hoc as designated.
Provide signature authority for CSRs, Health Authority Briefings, DMC Charters, Unblinding Requests, Health Authority Documents for Filings, and other delegated clinical accountable documents.

Requirements

Greater than 12 years of extensive clinical trial, drug development, and regulatory experience.
Strong scientific background.
Management experience required.
Understand early-stage drug development.
Extensive experience designing and conducting Phase I, II, and III clinical trials.
Demonstrable success filing regulatory dossiers and prosecuting them through approval.
Experience interacting with business development and licensing, particularly helping to evaluate the technical and franchise aspects for potential in-licensing opportunities.
Proven track record in managing complex clinical programs leading to regulatory submissions.
Deep understanding of biology, targets, and translational science.
Extensive experience working with health authorities at all levels.
Proven differentiated ability to support and manage across the totality of the spectrum including development of registrational and non-registrational trials.
Proven ability to execute the BMS R&D People Strategy, and lead and develop a matrix team.
Highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory.
Comfortable with cross-functional drug and product development teams and managing in a matrix environment.
Skilled at interacting externally and at speaking engagements.
Skilled at attracting, developing, and retaining skilled professionals.
Consideration for employment of qualified applicants with arrest and conviction records, pursuant to applicable laws.

Skills

Clinical development strategy
Clinical trial design
Clinical trial execution
Regulatory filings
Business development due diligence
Lifecycle management
Matrix management
Talent development
Stakeholder engagement
External communication
Thought leader engagement
Patient advocacy
Cross-functional collaboration
Team leadership

Location

Global

Work Type

On-site
Hybrid
Field-based
Remote-by-design

Experience Level

Greater than 12 years
Management experience

Education Level

MD (PhD or other high level degree optional)

Benefits

Wide variety of competitive benefits, services and programs

About the Company

Bristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing, manufacturing, and marketing innovative medicines that help patients prevail over serious diseases.
Our vision is 'Transforming patients’ lives through science™'.
We foster a supportive culture, promoting global participation in clinical trials.
Our shared values are passion, innovation, urgency, accountability, inclusion, and integrity.

Equal Opportunity

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
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.
Bristol Myers Squibb is Disability Confident – Employer