Director, Early Clinical Development - Immunology & Fibrosis

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.

Division

R&D / Early Clinical Development (Hematology/Oncology and Cell Therapy (HOCT) or Immunology, CV, and Fibrosis (ICF))

Functional Area Description

The Early Clinical Development function is part of a global organization dedicated to the effective design and execution of early drug development. Early Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.

Position Summary / Objective

• Serves as a primary source of medical accountability and oversight for multiple clinical trials
• Manages Phase I/II studies, with demonstrated decision making capabilities
• Provides medical and scientific expertise to cross-functional BMS colleagues
• Maintains matrix management responsibilities across internal and external networks

Position Responsibilities

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 to support development, and
  • Serving as principal functional author for Regulatory submission, study reports, and publications
• Provides oversight and medical accountability for multiple trials across early development clinical lifecycle
• Manages site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
• Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
• Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
• Collaborates with CS and provides input into protocols, contributing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
• Acts as a focal point for defining and establishing relationships with key global Phase I Centers
• Works on multiple trials across early development clinical lifecycle

Clinical Development Expertise & Strategy

• 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, and/or clinical pharmacology studies
• 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)
• Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists
• Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
• Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder
• Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature
• Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
• Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and others
• Ad-Hoc involvement in various departmental 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

• Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects
• Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists

External Partnerships, Alliances, and Publications

• 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 with oversight
• Acts as a focal point for defining and establishing relationships with key global Phase 1 Centers
• Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)

Degree Requirements

• Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent)
• Subspecialty fellowship training in applicable therapeutic area preferred

Experience Requirements

• 5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable
• Clinical trial leadership experience (e.g., study director, translational or biomarker scientist etc.) within pharmaceutical industry preferred OR
• Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting preferred including demonstrable achievement in experimental design, interpretation and exposition

Key Competency Requirements

• Ability to communicate and present information clearly in scientific and clinical settings
• Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
• Knowledge of drug development process
• Knowledge of the components needed to execute an effective clinical plan and protocols
• Strong leadership skills with proven ability to lead and work effectively in a team environment

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.