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Job Details


Bristol-Meyers Squibb, Co.

Associate Director, Clinical Capabilities (R1558455-en-us)

Pharmaceuticals

All

Yearly

No

Princeton, New Jersey, United States

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 Center of Excellence (CCoE) department serves all of Clinical Research and Development across all Therapeutic areas with the objective of enhancing our clinical capabilities within the 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 Associate Director, Clinical Capabilities will report into the Clinical Capability Lead (CCL).

Position Summary / Objectives

The Associate Director, Clinical Capabilities (ADCC) provides clinical and scientific guidance to the cross therapeutic area Clinical Research and Development organization regarding processes, systems and tools utilized in clinical trials. Requiring minimal supervision, the ADCC supports the CCL (Clinical Capabilities Lead) and may serve as the primary contact and advisor for Clinical capabilities within the Clinical Research and Development organization. This role works closely with cross-functional partners, including Vendors and CROs, to ensure continuous improvement of processes and the highest quality standards.

The ADCC will support the CCoE community of practice focused on enhancing clinical development innovation, execution, and delivery to promote a culture of continuous improvement and operational excellence.

Position Responsibilities

Clinical Training and Education Management

  • Lead the CCoE learning sessions and trainings to the clinical development organization in partnership with R&D Learning as applicable.

  • Drive the coordination and agenda management of CCoE leadership meetings.

  • Contribute to the development and maintenance of the Clinical Scientist & Clinical Trial Physician onboarding programs for new employees.

Clinical Process Improvement

  • Drive and coordinate the reviews of procedural documents (SOPs, WIs, Job Aids) utilized by the clinical development organization and ensure alignment with the clinical leadership team.

  • May serve as the process lead and or subject matter expert (SME) for clinical owned processes (e.g. Clinical Protocol, DMC, SSC, Protocol Deviations, safety narrative review, etc.)

  • Lead assigned projects with minimal supervision by manager

  • Represent Clinical during inspections and audits, and support management of responses and CAPA resolution for clinical development related findings.

  • 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.

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

  • Attend and lead team meetings as needed for assigned projects

  • Interface with clinical and other functions for scientific and functional guidance

  • Identify & escalate current/active issues to manager

  • Enact best practices

  • Contribute to CCoE and cross functional continuous improvement initiatives

  • Actively seek and receive coaching/mentoring

  • Provide regular and timely updates to manager

Degree Requirements

  • Degree in Life Sciences (pending degree/graduation date may be acceptable)

Experience Requirements

  • 7+ years of experience in clinical research, project management and/or learning and training management or equivalent

Key Competency Requirements

  • Experienced in CR&D roles/responsibilities or equivalent

  • Awareness of GCP/ICH, drug development process, study design, statistics

  • Excellent verbal, written, communication, and interpersonal skills

  • Detail-oriented, project management skills

  • Demonstrate critical thinking & problem-solving skills

  • Exhibit commitment to Quality

  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)

  • Skilled in Microsoft Word/Excel/PowerPoint/SharePoint

  • Ability to quickly learn clinical research systems

Travel Required

Domestic 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 . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

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