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

Key technologies and capabilities for this role

Clinical DevelopmentClinical TrialsProtocol DevelopmentStudy DesignData AnalysisOncologyRadiopharmaceuticalsNDAMAAMedical Writing

Questions & Answers

Common questions about this position

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 their personal lives.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What are the key responsibilities for the Associate Director of Clinical Science role?

Key responsibilities include developing study concept synopses and protocols, participating in protocol reviews, preparing study documents, contributing to CRF and data analysis plan design, reviewing clinical data, and supporting regulatory filings like INDs and NDAs.

What is the company culture like at Bristol Myers Squibb?

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

What makes a strong candidate for this Associate Director role?

Strong candidates have knowledge of clinical trial design, experience in protocol development and review, ability to collaborate on study documents and data analysis, and skills in supporting regulatory submissions, with capability to coordinate teams.

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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