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.

The Head of Clinical Trial Risk Management reports to the Head of Clinical Compliance and Risk Management under Global Clinical Compliance & Continuous Improvement in BMS Global Development Operations (GDO) and leads a team of Risk Management Leads. This role is critical in enabling corporate and R&D objectives and supports Quality by Design principles by establishing, maintaining, and operationalizing a robust framework for Clinical Trial Risk Management at the study level, in partnership with stakeholders across R&D, and collaborating with Global Quality regarding non-study specific Risk Management, thus ensuring Quality Risk Management end to end.

• For outsourced studies or studies conducted in collaboration with strategic development partners, the Head of Clinical Trial Risk Management also ensures appropriate oversight from a clinical compliance standpoint. In close collaboration with the study teams, Alliance Management, Global Quality, Global Procurement, IT, etc. this role supports the development of robust vendor management oversight plans and establishes a comprehensive interface for risk and issue management with strategic development partners. The group may be involved in due diligence activities during the vendor selection process.
• The Head of Clinical Trial Risk Management is partners with R&D Functions, Global Quality, other Regional/Partner GCP Councils and Business Insights & Analytics to establish, maintain, and report quality metrics/trends to the GCP Council, as well as escalated issues across the GCP spectrum.
• As a compliance function, the Clinical Trial Risk Management organization provides day-to-day support to central GDO study teams (including but not limited to operations leads, protocol managers) and their line management to ensure prevention of issues, early identification of issues, and provide expert advice on identification of root causes and development of Correction Action/Preventive Action (CAPA) plan and related effectiveness measures. For internal audits and Health Authority inspections, this organization provides support, as needed, to the central study teams in collaboration with Global Quality to ensure inspection preparedness and timely development of CAPA responses.
• Whether quality issues stem from audit findings, Health Authority inspections, or are self-identified, this organization also supports the tracking of these CAPA plans to completion, and escalation to the appropriate governance as necessary.

Responsibilities

• Team and matrix leadership, escalation, and resource management.
• Quality Risk Management oversight at the study level end-to-end.
• Key stakeholder engagement across R&D, Global Quality, and other support functions, as well as senior leadership when it comes to management of GCP-related quality issues within GDO, including serious breach, and escalation.
• Close partnership with other Clinical Compliance functions within and outside of GDO, Global Process Owners, and other support functions, to ensure a Community of Practice centered on Quality by Design, Clinical Trial Risk Management, efficient Issue Management, and Continuous Improvement. Always fosters a mindset of inspection readiness.
• Day-to-day GDO support of Quality by Design, issue management, root cause analyses and management and tracking of CAPA plans.
• Ambassador for a culture of Quality Excellence, transparency, customer focus, and enterprise growth mindset.
• Ensure appropriate GCP Compliance oversight of vendors, and interface with strategic development partners.

Qualifications

• A minimum of a bachelor’s degree (or equivalent degree) is required. Degree in a life science, natural science or business is preferred.
• Knowledge of the global drug development process is required, with at least 8 years of GCP-related experience in clinical operations (e.g., site, sponsor, and/or CRO).
• Experience in and/or knowledge of risk management in a regulated industry is required.
• Experience in managing teams of diverse individuals, ability to operate in a matrix organization and manage competing priorities with a sense of urgency.
• Ability to clearly communicate with stakeholders and manage dynamic tensions.
• The candidate will demonstrate the ability to adopt a biopharma enterprise-wide mindset, to act with speed, accountability, and integrity, and to have fun along the way. This role has the potential to evolve to a broader scope within Global Clinical Operations.
   

Travel Required

• Some domestic and international travel may be expected.

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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