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Sr Director Solid Tumors Therapeutic Area

Location
Princeton, NJ, United States

Posted on
Jun 22, 2020

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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.

Sr. Director-Oncology Solid Tumors Therapeutic Area, Medical Affairs, Late Development, Investigator Sponsored Research - Global Development Operations

The Therapeutic Head of Clinical Operations 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.

Specifically, the Therapeutic Head of Clinical Operations acts as general manager for all strategic and executional activities within a specified therapeutic area in either in late phase development and Medical funded portfolio. Key accountabilities are:

Providing strategic and clinical operational leadership across a therapeutic area for Oncology solid tumors.

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 R&D and Medical, 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 and medical 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 any therapeutic area (e.g. ASCO, ESMO) 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 work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.

Experience and expertise required:

Bachelor's degree required with an advanced degree preferred. At least 15 years of relevant industry experience, with 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.

Demonstrated ability to collaborate and build strong relationships with Senior Leaders within and outside of Research & Early Development (RED), Global Drug Development (GDD) Clinical Development, Worldwide Commercial, Global Regulatory, and Medical Affairs.

Strong influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.

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.

Company: Bristol-Myers Squibb

Req Number: R1526798_EN

Updated: 2020-06-22 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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