Associate Director, Clinical Science at Bristol-Myers Squibb

San Diego, California, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

PharmD or PhD preferred
6+ years of relevant drug development experience with an MS; 8+ years with a BS degree in Biological Sciences, health care, or a related field
Minimum of 5 years’ experience in clinical research or clinical pharmacology in a biotech/pharmaceutical company or contract research organization
Excellent verbal and written communication skills and interpersonal skills
Demonstrated ability to be a fast learner
20% travel required

Responsibilities

Acquires and utilizes knowledge of clinical trial design to develop or oversee development of specific study concept synopses and protocols
Participates in protocol review discussions concerning scientific and procedural aspects of study design
In collaboration with Medical Writing and Clinical Operations, prepares study protocols, amendments, specific sections of study manuals and Investigator meeting materials, and other documents as needed with appropriate guidance and supervision
Contributes to the design, development, and review of CRFs, Data Management Manuals, and Data Analysis Plans
Reviews ongoing clinical data
Organizes and oversees Data Review Committee meetings, including preparation of slides and other review and meeting materials
With MD supervision, addresses questions regarding scientific and related procedural issues from Investigators
Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations
Assists in the preparation/review of INDs, regulatory documents, IND annual report/DSURs, Investigator Brochures, and NDAs/MAAs
Supports priorities within functional area; anticipates moderately complex obstacles within a clinical study and, with guidance, implements solutions
May coordinate teams and provide direction; may lead two or more specific components of departmental strategic initiatives
Able to enter a new therapeutic area and summarize scientific information from published literature to integrate into new study development

Skills

Clinical Development

Clinical Trials

Protocol Development

Study Design

Data Analysis

Oncology

Radiopharmaceuticals

NDA

MAA

Medical Writing

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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