Cell Therapy Development Clinical Leader - Transition Assets and Cross-Portfolio Team Lead

Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.

Role Imperatives:

• 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:

  • CSRs

  • Health Authority Briefings

  • DMC Charters

  • Unblinding Requests

  • Health Authority Documents for Filings

  • And other clinical accountable documents delegated as needed

Technical Qualifications:

• 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.

Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.

Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.