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Executive Director – Head of Clinical Design & Delivery Center
Bristol Myers Squibb. Provide strategic leadership and oversight of the Protocol Management Office (PMO) .
Posted 9/22/2026full-timePrinceton • New Jersey • United StatesLead💰 $297,590 - $360,603 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in clinical development, protocol management, and regulatory compliance, with a strong focus on innovative solutions and cross-functional collaboration. Proven ability to lead high-performing teams and drive strategic initiatives that enhance clinical study design and execution.
Highest-signal resume keywords
Clinical Development LeadershipProtocol Development and ReviewRegulatory and Compliance KnowledgeStakeholder CollaborationProblem-Solving and Process Simplification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Protocol DevelopmentStatistical Analysis Plans (SAPs)Data Monitoring Committee (DMC) ChartersClinical Study DesignMetrics and Indicators DevelopmentQuality by Design ImplementationReal-World Evidence UtilizationAI in Trial DesignClinical Development Plan (CDP)Integrated Asset Development Plan (IADP)
Soft Skills
Leadership Through InfluenceCollaborationCustomer FocusAccountabilityProblem-Solving
Tools & Technologies
FAROQuality Management Systems (QMS)
Certifications & Qualifications
Degree in Life Sciences (MD, PhD, PharmD, MS, RN)
Industry Keywords
Clinical OperationsEpidemiologyDrug DevelopmentRegulatory RequirementsCompliance Standards
About the role
Key responsibilities & impact- Provide strategic leadership and oversight of the Protocol Management Office (PMO)
- Lead review of clinical protocols, statistical analysis plans (SAPs), Data Monitoring Committee (DMC) charters, and other critical study documents across the BMS portfolio
- Provide scientific review, commentary, and revision of pivotal protocols and documents across all therapeutic areas
- Oversee coordination of review activities and align resources with required activities
- Liaise with senior Drug Development stakeholders and support consistent review processes
- Ensure studies meet scientific quality, feasibility, regulatory, and compliance standards
- Develop and refine protocol/document submission processes and triage criteria
- Integrate review processes into overarching governance processes
- Maintain compliant systems for storing and retrieving review materials, meeting outputs, and decisions
- Develop metrics and indicators for protocol development and continuous improvement
- Incorporate advances and external insights into protocol development and study design
- Lead educational and training programs for clinical physicians and scientists
- Develop training materials with BMS Learning
- Contribute to a best-practices hub and nurture internal knowledge-sharing communities
- Lead initiatives enhancing clinical development innovation and efficiency
- Oversee clinical process development, maintenance, measurement, and compliance
- Contribute to Clinical Development Plan (CDP) and Integrated Asset Development Plan (IADP) processes
- Partner with Data and Quantitative Sciences and Real World Data Research/IT to use real-world evidence and AI in trial design
- Streamline the study design and protocol development journey
- Collaborate with Global Quality and Risk Based Management to embed Quality by Design and critical-to-quality factors
- Serve as Global Process Owner for Protocol development within the QMS network
- Evaluate and implement industry-leading capabilities and enterprise initiatives
- Lead implementation of AI and technology, including FARO, to optimize protocols and reduce patient/site burden, cost, and amendments
- Monitor KPIs for innovative protocol and protocol-process solutions
- Evaluate cross-functional ways of working across the OneClinical model
- Foster innovation, collaboration, customer focus, accountability, and commitment to results
- Report to the SVP, Head of Drug Development Strategy & Innovation
Requirements
What you’ll need- Degree in Life Sciences (MD, PhD, PharmD, MS, RN, or other scientific field preferred)
- Minimum of 10 years of experience in clinical development and the design and execution of clinical studies
- Deep knowledge of regulatory and compliance requirements, clinical operations, statistics, and epidemiology
- Deep understanding of early through late-stage drug development issues and challenges
- Extensive experience with protocol development and review
- Excellent problem-solving capabilities with ability to understand and simplify processes and interfaces between complex organizations
- Successful track record of leading through influence and working across complex, global organizational matrices
- Proven ability to lead during significant change and establish credibility and influence executives through formal and informal leadership
- Track record of meaningful value creation and solution delivery through innovative ideas and agile execution
- Track record of developing goals and achieving business impact
- Exceptional capability to build alignment with senior-level business partners and collaborate with EVP/SVP/VP-level stakeholders and partners
- Successful track record of building, leading and maintaining high-performing teams
Benefits
Comp & perks- Additional discretionary incentive cash and stock opportunities
- Wellbeing support
- Retirement and financial protection benefits
- Medical, dental, vision, life and disability insurance offerings
- Flexible Time Off (FTO) for U.S.-based exempt employees
- 11 paid company holidays each year
- 160 hours of paid vacation annually for eligible new hires
- 3 optional holidays for eligible employees
- Paid sick leave
- Up to two paid volunteer days per year
- Summer hours flexibility
- Medical, personal, parental, caregiver, bereavement, or military leaves of absence
- Annual Global Shutdown between Christmas Day and New Year's Day
- Reasonable workplace accommodations/adjustments and ongoing support
- Flexible work models, including site-essential, site-by-design, field-based and remote-by-design