Clinical Development Lead Prostate (ACP3) 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, Pharmaceuticals, OncologyIndustries

Requirements

MD or equivalent with sub-specialty training in oncology
At least 8 years of pharmaceutical/biotech experience in oncology solid tumor clinical development
Drug development experience in GU cancer, prostate cancer, lung cancer, or other solid tumor cancers
Radiopharmaceutical experience preferred but not required
Willing to travel approximately 30% of the time

Responsibilities

Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates
Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies
Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents
Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators
Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
Translate findings from research and nonclinical studies into clinical development opportunities
Oversee Data Review and Independent Data Monitoring Committees
Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
Establish and maintain positive relationships with clinical trial investigators and thought leaders
Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings
Supervise and mentor clinical scientists and medical directors

Skills

Key technologies and capabilities for this role

Clinical DevelopmentProstate CancerIND PreparationRegulatory InteractionsPhase 1 TrialsPhase 2 TrialsPhase 3 TrialsMedical MonitoringRadiopharmaceuticalsClinical Trial DesignCross-Functional Collaboration

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 role remote or does it require working from an office?

This information is not specified in the job description.

What are the main responsibilities for the Clinical Development Lead role?

Responsibilities include designing clinical development plans for prostate cancer assets, leading internal project teams, partnering with investigators and CROs, contributing to protocols and regulatory documents, conducting investigator meetings, and overseeing data review committees.

What is the company culture like at Bristol Myers Squibb and RayzeBio?

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 in the work environment.

What experience makes a strong candidate for this Clinical Development Lead position?

Strong candidates will have expertise in clinical development for oncology, particularly prostate cancer, with experience in designing Phase 1-3 trials, IND preparation, regulatory interactions, and leading cross-functional 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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