Associate Director, PMDH at Bristol-Myers Squibb

Warsaw, Masovian Voivodeship, Poland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Medical DevicesIndustries

Requirements

Bachelor's degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.)
At least 7 years of US or EU Medical Device Regulatory Affairs experience
Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance
Experience utilizing leadership techniques to drive a team through the stages of team development
Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives
Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor
Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry
Strong background in regulatory affairs, team leadership, and project management within the medical device and pharmaceutical industries

Responsibilities

Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies
Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers
Ensure consistent positions are presented in responses to global Health Authority (HA) queries
Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global Regulatory sub-team, develop global submission plans and HA interaction plans
Provide input into the development of protocol synopses and protocols
Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines
Contribute in the developing of target labeling

Skills

Regulatory Strategy

Biomarkers

Companion Diagnostics

Digital Health Solutions

Medical Devices

Global Filing Strategies

Health Authority Interactions

Project Management

Team Leadership

Protocol Development

Clinical Trial Applications

Target Labeling

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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