Job Description

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Functional Area Description

The Clinical Capability Lead reports to the Head of the Clinical Center of Excellence.   

The Clinical Center of Excellence  department serves all of Clinical Research and Development across all Therapeutic areas with the objective to enhance our clinical capabilities within OneClinical organization  and optimize our ways of operating with a focus on Innovation, Consistency and Quality across the enterprise.    The CCoE serves as the operating bridge between the multiple Therapeutic Areas  in both late development and early development  striving to build a culture of excellence. 

The Clinical Capabilities Lead (CCL) provides clinical and scientific leadership that supports Clinical Development Organization with processes, systems and tools utilized in clinical trials. The CCL serves as the primary contact and advisor for Clinical capabilities within the Clinical Development organization.  This role works closely with cross-functional partners, including Vendors and CROs, to ensure continuous improvement of processes and highest quality standards.

The Clinical Capability Lead is accountable to drive process optimization and improvement following standard methodology, ensure resources are identified and aligned at the team-level to drive process optimization activities, and lead optimization to align with the Good Clinical Practices document hierarchy.

Position Summary / Objectives

The purpose of this role is to ensure consistent global leadership for key R&D Quality Clinical processes within Global Drug Development, serving as the key point of contact for assigned processes and key decision-maker for assigned processes.   The Clinical Capability Lead will ensure role definition and clarity on key accountabilities for process steps through an enterprise lens.  The CCL will establish, track, and trend process metrics to achieve Quality Outcomes and will lead Community of Practice (CoP) with other PLs, and Subject Matter Experts (SME).

The CCL will be responsible for aligning with key clinical leadership stakeholders including Clinical Therapeutic Heads (TAH), Clinical Development Heads and Clinical Science Heads across all therapeutic areas in GDD and RED and promote a culture of continuous improvement and operational excellence

The CCL will support the CCoE Head in 1)  the development of best practices Hub focused on enhancing clinical development innovation, execution, and delivery and 2) leading a group focused on developing and maintaining clinical processes and serving as senior voice in supporting quality and compliance-related activities across development

The CCL will lead the development and delivery of educational and training programs focused on advancing clinical development capabilities while developing a high functioning community of practitioners as well as lead initiatives focused on enhancing clinical development innovation and efficiency.

Position Responsibilities

• Oversee efforts to develop and deliver educational and training materials in concert w/ BMS learning with an intended audience of clinical physicians and clinical scientists.

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

• Incorporate outputs from initiatives across the enterprise into the clinical 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 deliverables

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

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

• Partner with the CCoE Ambassadors/Leadership Team for the development and implementation of quality objectives for Global Clinical R&D.

• Serving as the key point of contact for assigned processes and key decision-maker for assigned clinical processes

• Support the management of Clinical Scientist, Clinical Trial Physician, Clinical Development Lead curricula for applicability and assignment

• Develop and manage on-boarding process for new employees and contingent workers

• Represent Clinical during inspections and audits, and with responses and CAPA resolution

• Lead work streams for a large global GCP Quality Management Systems (QMS) Optimization project

• Cultivate business relationships to provide program leadership in a highly matrixed environment

• Actively engage with leadership from business case development through program delivery, broker the delivery of critical programs within the portfolio, ensure organizational alignment on scope, schedule, quality, benefits and implement and monitor appropriate controls to proactively deal with barriers to completion

• Navigate cross-functional team through ambiguity towards a clear and actionable decision

• Participate/lead benchmarking initiatives with peers externally to stay abreast of new ways of working and evolving technologies in this space

• Ensure consistency of processes and best practices across the global clinical R&D enterprise

• Determine root cause and corrective actions for platforms and systems that affect Clinical processes and efficiencies (e.g., protocol deviation process, CTMS); lead implementation efforts

• Represent Clinical in resolving Vendor/CRO issues that affect trial data and patient safety; develop and ensure implementation of corrective actions and prevention

Degree Requirements

Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)

Experience Requirements

• 10+ years of experience in clinical science, clinical research, or equivalent (must include 7 years of clinical development experience in the Biopharmaceutical Industry)
• Experience and demonstrated proficiency in managing direct/indirect employees and leading teams

Key Competency Requirements

• Demonstrates strong leadership presence

• Thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of quality issues, audit findings, clinical non-compliance, and serious breach investigations

• Strong program and project management experience with proven track-record of several years managing cross-functional programs and ability to manage multiple, simultaneous projects, preferably in Quality and Compliance

• Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities

• Experience with partner management

• Recognized internally and externally as a Functional/Technical expert

• Track record of commitment to Quality in all areas

• Exhibits confidence and professional diplomacy, while effectively relating to people at all levels (internally and externally)

• High proficiency in, and demonstration of, critical thinking, problem solving, and decision making

• Anticipates needs, and assesses and manages business and organizational risks

• Proven ability to promote a culture of scientific excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication

• Prior success in situations requiring adaptability/ flexibility

• Proven ability to self-supervise and act independently to identify/resolve issues

• Advanced knowledge of GCP/ICH, drug development process, study design and clinical operations

• Advanced oral and written communication skills, including medical writing

• Able to present to large groups, facilitate interactive discussions, and lead 1:1 discussions with internal and external thought leaders

Travel Required

Domestic and International travel may be required.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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