Executive Director, TA Head, Global Clinical Strategy & Operations, Cell Therapy
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.
Job Title: The Executive Director, TA Head, Global Clinical Strategy & Operations, Cell Therapy
The Executive Director, TA Head, Global Clinical Strategy & Operations will have oversite and accountability for all strategic and executional activities within the Cell Therapy therapeutic area encompassing research and early development, full drug development and late phase development.
Summary and Objective:
The Executive Director, TA Head, Global Clinical Strategy & Operations, Cell Therapy is a senior role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Vice President of Global Clinical Trial Strategy & Operations (CTS&O) within Global Development Operations (GDO) and is a key member of CTS&O Leadership
Providing strategic and clinical operational leadership across the cellular therapy therapeutic area.
Assuring the implementation of that therapeutic area strategy through one of the following phases – supporting early development bringing the assets through proof of concept; supporting full development to secure regulatory filings; supporting late development focused on non-registrational drug development programs - Phase IV studies, patient access programs and investigator initiated studies.
Driving the performance, operational quality, innovative development strategies/trial designs, and the timely contributions to assure successful implementation, execution, and delivery across the entire therapeutic area.
Partnering with the key areas of the R&D business, he/she provides oversight and leadership that supports the design and execution of development programs that enable proof of concept, regulatory approvals or successful market access. Serving as an escalation point, when development teams are not able to resolve conflicts and is a core member of cross-functional leadership teams.
Ensuring the operational execution of all clinical development programs within the therapeutic area; providing operational insight into study designs; ensuring the timely recruitment of BMS-sponsored clinical trials; assuring the collection and cleaning of clinical data; ensuring oversight through to support regulatory filings (as relevant); and developing/maintaining relationships with key clinical trial sites and investigators in the therapeutic area.
In collaboration with clinical compliance and other functions, support strict adherence to GCP principles, enabling ongoing inspection-readiness and successful implementation of CAPAs.
Leading a multi-national team of clinical trial professionals, who are experts in the execution of clinical operations, contributing significantly to BMS portfolio of clinical trials. Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empowers and holds GDO management to high-quality performance and delivery of the business.
Representing the Company in key interactions with key external partners as part of Cell Therapy therapeutic area committee or industry group.
Serving as a leader within Global Development Operations (GDO) and developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.
Ensuring GDO representation as needed in governance or strategic teams or committees (preparatory materials, direct participation, or representative).
Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities.
Developing and promoting a workplace culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.
Minimum BS or BA degree, advanced degree preferred
> 15 yrs. of relevant industry experience
Substantial experience of managing senior clinical operations staff in a global setting. In-depth knowledge of the drug development process and overall planning, project management and clinical operations of a clinical development program.
Proven significant experience within the assigned therapeutic area.
Recognized skill in managing drug development programs, across multiple therapeutic areas, and major geographies.
Experience in the design strategy and execution of clinical programs across all phases of development including a demonstrated capability in support of proof of concept, full development and/or across marketed products.
Experience in conducting global clinical trial programs across major worldwide markets, including the partnership with CROs, SMOs, AROs and local site networks. Direct experience of leadership of a CRO or from within a CRO strongly preferred
Develops project standards and ensures consistency and efficiency across the program
Manages a disciplined approach to accurate documentation of the team’s work
Consistently makes operational decisions in a timely manner
Uses expert judgment to make sound decisions based on a balanced evaluation of available information within a complex environment of competing project priorities
Acts decisively to address team challenges
Contributes to business strategy from an operational perspective
Effective oral and written communication skills to influence inform and guide a large-scale global operational team.
Provides vision to build partnerships across functional area leadership
Consistently demonstrates positive attitude about the team’s ability to deal with challenges
Drives issues to resolution; communicates to ensure that issues have been worked through to completion
Applies change management principles to support communication and implementation of integrated change
Demonstrates diplomacy when interfacing with other functional areas, clinical research organizations (CROs) and other outside vendors.
Frequently communicates program status to different levels of stakeholders
Strong leadership competencies and influencing skills with senior leaders and cross-functional leaders.
Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.
Potential Travel: 25%
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.
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