VP, Clinical Center of Excellence - Princeton, United States - Bristol-Myers Squibb Company

Description

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Title: VP, Clinical Center of Excellence

Position Summary:

The VP, Clinical Center of Excellence will develop and lead a Protocol Management Office (PMO) responsible for the review of protocols, statistical analysis plans (SAPs), data monitoring committee (DMC) charters and other key documents across the BMS portfolio to ensure outputs of the highest scientific quality.

S/he will lead the development and delivery of educational and training programs focused on advancing clinical development capabilities and nurturing skills within the clinical physician and scientist organizations.

S/he will lead and participate on key initiatives focused on enhancing clinical development innovation and efficiency, lead a group focused on clinical development processes, and will serve as a senior voice in supporting quality and compliance-related activities across the development organization.

S/he will lead and drive the evolution and execution of strategic roadmap for CCoE based on the key business priorities and external industry trends.

VP, Clinical Center of Excellence is a member of the Portfolio & Strategic Operations leadership team and a senior P&SO representative for OneClinical, Drug Development, BI&A, IT, and Medical Affairs.

Additionally, s/he is responsible for driving external engagement and thought leadership on related clinical development process excellence topics in the industry.

S/he will advance BMS clinical development reputation externally through industry forums, conferences, and industry round tables; stay abreast of key industry trends and integrate learnings into CCoE strategy

Roles and Responsibilities:

Lead the BMS Protocol Review CommitteeDevelop and lead a Protocol Management Office (PMO) responsible for the review of protocols, statistical analysis plans (SAPs), data monitoring committee (DMC) charters, and other key documents/plans across the BMS portfolio to ensure outputs of the highest scientific quality.

Provide rigorous scientific review/comment/revision to pivotal protocols/documents across all BMS therapeutic areas (TAs) to ensure they meet appropriate levels of scientific quality.

Oversee a group of individuals that coordinates review activities across all BMS TAs. Ensures resources are commensurate with requisite activities.

Liaise with senior stakeholders (e.g., TA heads within Drug Development) in furthering the scientific quality of outputs and addressing issues that arise in the course of PRC review.

Provide guidance to the matrix team of PRC leaders within the TAs to drive consistent review and processes.
Ensure review process leads to high quality, scientifically rigorous, and feasible studies and meets regulatory / compliance standards. Develop and refine process to handle protocol/document submission as well as associated triage criteria.
Integrate protocol and document review process into overarching governance processes.

Create, implement, and maintain an integrated, organized compliant system for storing and retrieving PRC materials, meeting output, and decisions taken.

Develop metrics and collect indicators that enable ability to track output and trends associated with protocol development and can be applied to identify areas of continuous improvement.

Incorporate state-of-the-art advances as relates to protocol development/study design and associated review based on internal and external insights from industry, regulators, and other bodies.

Lead the development and delivery of educational and training programs focused on advancing clinical development capabilities while developing a high functioning community of practitionersOversee efforts to develop and deliver educational and training materials in concert w/ BMS learning with an intended audience of clinical physicians and scientists.

Support development of best practices hub focused on enhancing clinical development innovation, execution, and delivery.

Nurture a community of practitioners that optimizes collaboration through internal knowledge sharing to enhance the organization's clinical development skills and capabilities.

Lead initiatives focused on enhancing clinical development innovation and efficiency, lead a group focused on developing and maintaining clinical processes across Early and Late Development and Medical Affairs, and serve as senior voice in supporting quality and compliance-related activities across development.

Oversee group focused on developing, enhancing, maintaining, and measuring effectiveness / compliance of clinical processes.

Develop processes for Clinical Development Plan (CDP ) to facilitate early to late development transition, support portfolio decision-making, and accelerate design and protocol development.

Partner with Enterprise Governance, P&SO, BI&A, GBDS, and StuDIO to identify opportunities to support and streamline portfolio decision-making and accelerate downstream activities.

Partner with Study Design Innovation and Optimization (StuDIO) Head, GBDS leadership, GRSP, and BI&A to develop StuDIO capability, educate clinical teams on use of real world evidence and AI to inform trial design.

Streamline design and protocol development journey including TA technical review and PRC review.

Partner with Global Quality and GDO to develop vision for embedding and operationalizing Quality by Design throughout the trial lifecyleDevelop metrics to assess clinical development performance and identify actionable insights to inform process improvement (e.g., Clinical Development Plan,, protocol development and study start up).Partner with Quality and SIOE to develop a new model for Business Process Management building a framework to visualize business processes leveraging state of the art technology and insights.

Incorporate outputs from initiatives across the enterprise into the development process (e.g., digital innovation, real-world capabilities, and patient advocacy).Evaluate industry leading capabilities and support their implementation within BMS, as appropriate, in scalable fashion in support of clinical deliverablesServe as Clinical leader for Digital Protocol Solution (DPS), assessing use of state of the art AI and technology to accelerate clinical development processes including clinical protocol development, study start up and execution.

Evaluate cross-functional ways of working across the OneClinical model to evolve the model based on business needs.

Liaise with leaders across Clinical and P&SO enhance OneClinical resource algorithms.

Serve as clinical development subject matter expert to support quality and compliance efforts across the therapeutic areas and guide compliance to GCP.

Interface with key stakeholders across other departments to support a culture focused on quality across the Enterprise.

Be a strategic CCOE leader responsible for shaping teams to deliver medicine faster and in transforming patients' lives through science.

Help drive a high-performance culture by fostering innovation, collaboration, customer focus, personal accountability, and a commitment for results.
Engage and inspire the CCOE team through communicating the strategic vision and the operational plan to achieve the vision.

Qualifications & ExperienceDegree in Life Sciences (MD, PhD, PharmD, MS, RN or other scientific field preferred) with extensive 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, as well as extensive experience with protocol development and reviewExcellent 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 matricesChange Agent
- proven ability to lead during a time of significant change, and an ability to establish credibility and influence other executives through both formal and informal leadershipDrive for Results – track record of meaningful value creation and solution delivery through innovative ideas and agile execution; track record of developing goals and achieving business impactStakeholder Focus
- exceptional capability to build alignment with senior level business partners and collaborate effectively with stakeholders and partners at the EVP/SVP/VP levelTalent Development
- successful track record of building, leading and maintaining high-performingIf 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 CareersWith 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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

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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.

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