Cell Therapy Development Clinical Leader - Transition Assets and Cross-Portfolio Team Lead (R1556514-en-us-2)
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 Executive Clinical Team Leader will set the clinical development strategy for multiple transition assets across a broad range of tumor types.
This role will include above tumor strategy work (e.g., advising broad Clinical Development teams across several Development teams, as well as Disease Strategy teams, etc.)
The role will be foundational in working with teams in R & ED and GDD to support GT4/5 and POC transitions, providing insights into biology, translational elements as well as overall benefit risk assessments.
The role will supervise the development of differentiated and strategic CDPs for multiple transition assets and support a broad program of work from phase I expansion through to registrational execution.
The role includes support of across portfolio activities in line with Clinical Excellence, including Protocol Review Committee, support of Business Development activities and Quality and compliance leadership.
The role will report directly to the Head of Clinical Development and will deputize as required and will be a core member of the Cell Therapy clinical development executive leadership team.
Essential Leadership Behaviors:
Strategy and Execution:
Create and communicate a vision for designing, conducting and executing innovative clinical development plans for BMS Cell Therapy transition assets.
This leader will supervise the development, monitoring, analysis, and interpretation of clinical trials and will supervise and have accountability for the clinical components of regulatory filings.
Will contribute to overall cell therapy disease strategy for specific tumor types while ensuring a franchise overall portfolio view.
Provide strategic insights into the clinical development plans.
Lead search and evaluation activities on business development due diligence efforts, and advice to our strategic transactions group.
Key Member of Cell Therapy Clinical Development Leadership Team and chairing forum as required
Chair departmental Staff Meetings and represent governance meetings on an ad hoc basis
Will build a franchise reputation that attracts innovators to bring their ideas to BMS
Leadership and Matrix Management:
Supervise and develop a group of clinical Development professionals (team of up to 25 individuals both direct and indirect) whose therapeutic area focus is in specific tumor types and will ensure scientific and technical excellence of clinical development programs and deliverables.
This individual will recruit, develop and retain strong talent.
Mentoring of talent/staff
Will establish an effective and ethical culture that encourages teamwork, peer review, promotes cooperation and provides a supportive culture.
Will be responsible for developing a culture that values diversity of thought, supports coaching, fosters accountability and integrity, and supports process excellence and continuous improvement.
Stakeholder Engagement and Communication:
Will work closely with colleagues in BMS IO CT TRC, Research, Early and Late Development, Regulatory, Medical, Commercial and other key functional areas on a global basis; additionally, should have an external focus and build relationships with thought leaders, physicians, and patient advocacy groups outside of BMS. Be recognized internally and externally as an expert in the field.
Partner and interact with colleagues from Research and Early Development who design and implement first in human through proof of concept trials and will assure a seamless transition into late stage development (Phase II-III trials.)
Governance Participation and Signature Authority:
Governance participation ad hoc as designated
PRC Chair ad hoc
Signature Authority for:
Health Authority Briefings
Health Authority Documents for Filings
And other clinical accountable documents delegated as needed
Proven track record in managing complex clinical programs leading to regulatory submissions
Deep understanding of Biology, targets and translational science.
Extensive experience of work with health authorities at all levels.
Proven differentiated ability to support and manage across the totality of the spectrum including development of registrational and non registrational trials
Proven ability to execute the BMS R&D People Strategy, and lead and develop a matrix team.
MD or equivalent.
Desired background, knowledge and experience:
MD (PhD or other high level degree optional)
The ideal candidate will be a Clinical Development leader; with greater than 10 years of extensive clinical trial and drug development experience and regulatory experience, in addition to a strong scientific background.
The successful candidate will understand early-stage drug development, extensive experience designing and conducting Phase I, II and Phase III clinical trials, and should have demonstrable success filing regulatory dossiers and prosecuting them through approval.
Management experience will be important since this individual will manage a group of professionals including MDs or PhDs or PharmDs with clinical research experience.
The candidate also must be a highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory.
The candidate must be comfortable with cross-functional drug and product development teams and managing in a matrix environment.
Global experiences is a plus since this position has responsibility for strategy and clinical research in oncology in multiple geographies.
Experience interacting with business development and licensing, particularly helping to evaluate the technical and franchise aspects for potential in-licensing opportunities that shape the oncology clinical development strategy.
In addition, the candidate must be skilled at interacting externally, and at speaking engagements.
Must be skilled at attracting, developing, and retaining skilled professionals.
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.