Director, Early Clinical Development - Immunology (MD) at Bristol-Myers Squibb

Winter Garden, Florida, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

MD (Medical Doctor) degree (inferred from job title and medical accountability role)
Demonstrated decision-making capabilities in managing Phase I/II studies
Expertise in medical monitoring, including articulating clinical development strategy, analyzing/interpreting clinical trial data, and acting on it
Experience serving as principal functional author for regulatory submissions, study reports, and publications
Ability to manage site interactions, assess serious adverse events, and oversee safety narratives
Knowledge of GCP (Good Clinical Practice) and compliance obligations, with all required training
Experience in matrix management across internal and external networks
Skills in designing/developing clinical studies (Phase I, proof-of-concept Phase I/II, entry registrational, biomarker qualification, clinical pharmacology)
Ability to lead benefit/risk analysis in matrix team environments

Responsibilities

Serves as primary source of medical accountability and oversight for multiple clinical trials
Manages Phase I/II studies
Provides medical and scientific expertise to cross-functional BMS colleagues
Maintains matrix management responsibilities across internal and external networks
Acts as independent Medical Monitor for Phase 1 through Proof-of-Concept trials, including articulating strategy, analyzing data, and supporting development
Provides oversight and medical accountability for multiple trials across early development lifecycle
Manages site interactions in partnership with Clinical Scientist for medical questions, education, and safety management
Assesses key safety-related serious adverse events with Worldwide Patient Safety and oversees safety narratives
Contributes to Study Delivery Team (SDT) and Development Team
Collaborates on protocols, providing medical strategic oversight (e.g., inclusion/exclusion, safety considerations)
Fulfills GCP/compliance obligations and maintains training
Establishes relationships with key global Phase I Centers
Designs/develops clinical studies and research plans in support of asset strategy (e.g., first-in-human Phase I, proof-of-concept, biomarker studies)
Liaises with Clinical Scientists, Translational/Discovery Scientists, and Development Teams on dose/schedule, indications, patient selection
Leads benefit/risk analysis for protocols in matrix teams
Partners with Clinical Scientists for study execution (e.g., site activation, enrollment, adjudication)

Skills

Clinical Trials

Phase I

Phase II

Medical Monitoring

Immunology

Clinical Development

Proof-of-Concept

Biomarkers

Drug Candidates

Medical Strategy

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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