Associate 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.

Job Title

Associate Director, Early Clinical Development

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 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.

Position Summary / Objective

• Serves as a primary source of medical accountability and oversight for clinical trials
• Contributes to the management of Phase I/II Early Clinical Development studies
• Provides medical and scientific expertise to cross-functional BMS colleagues

Position Responsibilities

Medical Monitoring

• Serves as Medical Monitor with oversight for clinical trials from Phase I through Proof-of-Concept by
  • Articulating clinical development strategy
  • Analyzing, interpreting, and acting on clinical trial data to support development
  • Serving as principal functional author to regulatory submissions, study reports, and publications with review and oversight by functional leaders
• Manages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)
• Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narratives
• Supports Clinical Scientists with delivery of studies and input into protocols
• Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
• 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)
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training

Clinical Development Expertise & Strategy

• Contributes to design and development of clinical studies and translational research plans in support of asset strategy with guidance from 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
• Liaises with Clinical Scientists, Discovery and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)
• Supports analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists
• Partners with Clinical Scientists to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
• 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 Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
• Builds relationships with thought leaders and principal investigators to gather input on disease areas and study design

Health Authority Interactions

• Contributes to key Health Authority interactions and advisory board meetings as an Early Clinical Development physician
• Authors/drafts clinical content for clinical study reports (CSRs) regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists

Degree Requirements

• Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent)
• Subspecialty fellowship training in applicable therapeutic area preferred

Experience Requirements

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

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

Travel Required

Domestic and International travel may be required

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.