Director, Early Clinical Development - Immunology (MD)

Director, Early Clinical Development - Immunology

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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.

Functional Area Description

The Early Clinical Development - Immunology 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 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
• Serving as principal functional author for Regulatory submission, study reports, and publications

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, biomarker qualification 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 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.)
• 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 Clinical Scientists 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 I 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

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

Travel Required

• Domestic and International travel may be required

The starting compensation for this job is a range from $279,000-321,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our Working With Us (bms.com).

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive