Bristol Myers Squibb · 1 month ago
Director, Early Clinical Development (MD) – Hematology & Cell Therapy
Princeton - NJ - US
Full-time
Onsite
Lead/Staff, Director/Executive
$309K/yr - $374K/yr
5+ years expBristol Myers Squibb is a global biopharmaceutical company focused on transforming patients' lives through science. The Director, Early Clinical Development will oversee early clinical trials in cellular therapy for autoimmune indications, ensuring medical accountability and strategic oversight throughout the clinical development lifecycle.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
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
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
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
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
Sits on 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.)
Qualification
Required
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)
5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable
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
Preferred
Subspecialty fellowship training in rheumatology or hematology area preferred
Clinical trial leadership experience (e.g., study director, etc.) within pharmaceutical industry preferred
Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting preferred including demonstrable achievement in experimental design, interpretation and exposition
Benefits
Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-16
Pharmaceutical Technology
2026-01-16
Company data provided by crunchbase