Director, Early Precision Medicine Regulatory Affairs at Bristol-Myers Squibb

Princeton, New Jersey, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Deep scientific and regulatory expertise (US, EU, Canada, PMDA, TGA or Global Devices/IVD preferred)
Cross-functional leadership skills
Commitment to innovation in early precision medicine

Responsibilities

Drive the development and actively support the execution of innovative, compliant global regulatory strategies for biomarkers and diagnostic tests to enhance the impact and value of medicines across therapeutic areas
Design and operationalize a scalable regulatory framework within BMS that supports internal investigational assay development and clinical specimen testing, while overseeing external investigational use only assay development, ensuring strategic alignment with business needs and enabling timely, compliant submissions
Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee, providing strategic guidance and hands-on execution in the design, development, and testing of investigational use assays for patient selection and stratification in BMS Phase I/II studies, enabling business agility and advancing precision medicine
Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access, while ensuring early integration of precision medicine approaches, including coordination of key regulatory and clinical interactions

Skills

Key technologies and capabilities for this role

Regulatory AffairsPrecision MedicineGlobal Regulatory StrategyFDA RegulationsCell Therapy

Questions & Answers

Common questions about this position

What is the location for this position?

The position is located in either Lawrenceville or Madison, New Jersey.

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in personal lives, along with balance and flexibility in the work environment.

What skills and expertise are required for this role?

The role requires deep scientific and regulatory expertise, preferably in US, EU, Canada, PMD, TGA or Global Devices/IVD, along with cross-functional leadership and commitment to innovation in early precision medicine.

What is the company culture like at Bristol Myers Squibb?

The culture is challenging, meaningful, and life-changing, with uniquely interesting work every day, opportunities to grow and thrive alongside high-achieving teams, and a focus on balance and flexibility.

What makes a strong candidate for this Director role?

Strong candidates will have deep scientific and regulatory expertise in key regions like US, EU, or Global Devices/IVD, proven cross-functional leadership, and experience driving innovative global regulatory strategies for biomarkers and diagnostics in early precision medicine.

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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