Associate Director, Structured Benefit-Risk Assessment Lead at Bristol-Myers Squibb

Madison, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Ability to lead structured benefit-risk assessments from early clinical development through late-stage and post-marketing
Expertise in cross-functional collaboration with departments including medical safety assessment, clinical development, global regulatory, and epidemiology
Proficiency in benefit-risk assessment frameworks, tools, and methodologies (e.g., qualitative/quantitative methods, value tree, effects table)
Knowledge of regulatory guidance on benefit-risk assessment, patient preference studies, and patient-focused drug development
Experience guiding, steering, and mentoring cross-functional teams such as Benefit-Risk Project Teams (BRPT)
Capability to incorporate patient voice and patient preference studies
Ability to serve as subject matter expert on SBRA content, methodology, tools, and processes
Skills in monitoring regulatory landscapes and maintaining compliance/best practices
Experience establishing and maintaining relationships with external partners and thought leaders
Proficiency in developing procedural documents, training, and novel communication methods for benefit-risk processes

Responsibilities

Support Head of SBRA in defining and executing strategic vision for benefit-risk assessment function, aligning with organizational goals and regulatory requirements
Lead benefit-risk assessment process across therapeutic areas from early clinical development through late-stage and post-marketing
Guide, steer, and mentor cross-functional Benefit-Risk Project Team (BRPT) in structured benefit-risk assessments
Lead development of Core SBRA document and facilitate communication/collaboration among stakeholders to achieve consensus on benefit-risk profile
Lead strategic discussions on qualitative and/or quantitative methods for benefit-risk assessment
Lead BRPT in applying structured benefit-risk assessment frameworks/tools
Provide guidance on incorporating patient voice and patient preference studies
Serve as subject matter expert for BRPT and other functions on SBRA content, methodology, tools, and processes
Support development of decision context, identification of key benefits/risks, and documentation of rationale
Keep up to date with regulatory guidance on benefit-risk methodologies, patient preference studies, and related areas
Utilize and improve standard tools supporting benefit-risk assessment (e.g., frameworks, value tree, effects table)
Monitor evolving regulatory landscape for compliance and best practices
Establish, cultivate, and maintain external relationships with key partners and thought leaders
Assist with internal benefit-risk process development and training
Develop and maintain procedural documents related to benefit-risk assessment
Develop novel means to communicate benefit-risk assessments

Skills

Structured Benefit-Risk Assessment

SBRA

Benefit-Risk Framework

Pharmacovigilance

Clinical Development

Regulatory Affairs

Epidemiology

Cross-Functional Collaboration

Safety Assessment

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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