Oncology Development Clinical Team Leader Transition Assets

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Role Imperatives

The VP -Executive Clinical Team Leader will set the clinical development strategy for multiple transition assets across a broad range of tumor types.

The Clinical Team Leader will directly supervise the work of multiple Program Leaders, and medical Monitors, unless otherwise indicated.

This role will include above tumor strategy work (i.e. supervising Broad Clinical Development teams across several Development teams, as well as Tumor 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 e.g. 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 Oncology clinical development executive leadership team.

Strategy and Execution

Create and communicate a vision for designing, conducting and executing innovative clinical development plans for BMS Oncology 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 oncology tumor 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 Oncology 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

Lead 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.

Will be responsible for oversight of team budget and headcount

Stakeholder Engagement and Communication

Will work closely with colleagues in BMS Research, 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.

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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1519228_EN

Updated: 2020-02-10 00:00:00.000 UTC

Location: Princeton,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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