Job Description

Job Description

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.

Functional Area Description

The Early Clinical Development function is part of a global scientific organization dedicated to initial evaluations of new molecules, biomarkers, and mechanistic hypotheses in humans. The group drives early clinical strategy, and the design, execution, and interpretation of studies to select the most promising drug candidates for later development.

Serve as the clinical point of accountability for the Development Team and responsible for the overall clinical development plan for asset(s) in one or more indication(s)

Demonstrate matrix leadership to develop, motivate and achieve results through teams; enable development of a resilient attitude, embrace change and have an unwavering commitment to organizational People Strategy

Ensure studies are designed to meet regulatory, quality, medical, and access goals

Medical Monitoring

Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept by

Articulating clinical development strategy

Analyzing, interpreting, and acting on clinical trial data towards development

Serving as principal functional author for Regulatory submissions, study reports, and publications 

Independently synthesizes and/or contributes to plans (e.g., trial design, development strategy, regulatory strategy) based on merging data and multi-functional input

Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies

 Clinical Development Expertise & Strategy

Manages multiple/complex active programs concurrently across early development clinical lifecycles

Accountable for clinical contribution to the development of indication strategy

Partners with Worldwide Patient Safety physicians in the ongoing review of safety data

Provides clinical leadership and disease area expertise into integrated disease area strategies

Partners closely with KOLs in specific indications

Evaluates strategic options against a given Target Product Profile (TPP)

Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/Clinical Scientists, and raises to Development Team as needed

Sets executional priorities and partners with Clinical Scientists to support executional delivery of studies

Accountable for top line data with support of Clinical Scientists and Statisticians

Liaises with Clinical Scientists, Translational & Discovery Scientists, and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)

Liaises with other functions (e.g., Thematic Research Centers and Translational Medicine) and apply foresight and prioritize translational objectives in anticipation of development needs

Ad-Hoc involvement in various departmental or enterprise initiatives (e.g., committees, sub-teams etc.)

Presents and/or articulates clinical strategy to senior leadership and to support progression of portfolio

Health Authority Interactions

Serves as primary clinical representative in regulatory interactions for early development projects

Accountable for clinical contributions to clinical study reports (CSRs), regulatory reports, briefing books and submission documents

External Partnerships, Alliances, and Publications

Acts as a focal point for defining and establishing relationships with key Global Phase I Centers

Sits in team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies

Represents department in business development due diligence and partner alliance management as appropriate; sits on JDC/JRC/JSC as appropriate

Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)

Leadership and Matrix Management

May be responsible for managing Early Clinical Development Physicians, attracting, developing and retaining top talent; ensures appropriate training and mentoring of Early Clinical Development Physicians

Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct

Degree Requirements

Advanced degree(s) in relevant field: MD or MD/PhD and deep clinical expertise in a therapeutic area

Fellowship/specialty training in relevant therapeutic area preferred

Experience Requirements

7+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable

Extensive experience in clinical trial design and execution, biomarker development, and development strategy in pharmaceutical industry

Deep understanding of pharmaceutical discovery, development and commercialization

Track record of mentorship and/or management and/or matrix leadership

Demonstrated leadership abilities in a matrix environment

Key Competency Requirements

Excellent skills in clinical development strategy including the clinical components of regulatory submission(s)

External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS

Partner and interact with colleagues from Late Development to assure a seamless transition into late stage (Phase II-III trials)

Domestic and International travel may be required