Director, Clinical Pharmacology and Pharmacometrics 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, Biotechnology, OncologyIndustries

Requirements

Ph.D. in pharmacokinetics/pharmaceutical science or relevant field with at least 8-10+ years’ experience working in clinical pharmacology
OR PharmD with post-doctoral training and at least 8-10+ years’ experience working in clinical pharmacology
OR MS in pharmacokinetics/pharmacology or relevant field with 12-15 years experience

Responsibilities

Serves as a key member of the CP&P leadership team
Responsible and accountable for assigned clinical pharmacology strategy within assigned projects
Contributes to integrated strategy with R&ED, GDD, and Commercialization
Directs clinical pharmacology scientists in the development of strategy and execution of clinical PK, PK/PD, pharmacometric analyses, and modeling & simulation (MS) plans
Drives decision-making and strategy over the entire portfolio through effective partnership with partner functions and senior leaders
Oversees scientific output, conduct and resourcing of clinical pharmacology, PK/PD, working in concert with pharmacometrics and QSP functional partners
Supports strategy for dose selection, dose justification and regulatory filings
Reviews and approves relevant scientific data and reports for regulatory filings
Develops technical/leadership skills of clinical and MS scientists
Participates in, or assigns qualified delegates to support in-licensing and out-licensing business development activities
Represents Clinical Pharmacology on relevant governance committees and work streams
Oversees planning, execution of clinical pharmacology trials in concert with clinical operations
Represents the ClinPharm department on cross-functional disease strategy teams and on relevant governance forums
Provides input to Phase 2/3 clinical study design and registrational strategy
Supervises the development of the Clinical Pharmacology Plan(s)
Supervises design of Clinical Pharmacology studies and manages data analysis, interpretation, and reporting
Collaborates on cross-functional drug development teams, regulatory submissions, and departmental initiatives; serves as Clinical Pharmacology subject matter expert
Represents the CP&P line and as Subject matter expert in interactions with health authorities
May work on key internal initiatives and serves as department representative on relevant external initiatives
Builds a team that is collaborative, supportive learning environment

Skills

Clinical Pharmacology

Pharmacometrics

Oncology

Radiopharmaceuticals

Drug Development

IND

NDA

BLA

MAA

Team Leadership

Pharmacokinetic Modeling

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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