Clinical Development Lead (Senior Director), Oncology at Bristol-Myers Squibb

Princeton, New Jersey, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge
At least 10 years of relevant experience

Responsibilities

Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication
Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians
May serve as CTP as necessary
Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs; proactively partner with these roles
Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents
Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
Serves as the (co-)leader of the cross-functional Clinical Development Team
Provides clinical leadership and disease area expertise into integrated disease area strategies
Partners closely with KOLs in specific indications
Serves as Primary Clinical Representative in Regulatory interactions
Evaluates strategic options against a given Target Product Profile (TPP)
Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed
Sets executional priorities and partners with CTP and CS to support executional delivery of studies
Accountable for top line data with support of CTP, CS, and Statisticians
Serves as the clinical point of accountability for the Development Team and is responsible for the overall clinical development plan for asset(s) in one or more indication(s)/tumor type(s)
Ensures studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goals
Serves as a matrix leader to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs)

Skills

Key technologies and capabilities for this role

Clinical DevelopmentOncologyClinical TrialsDrug DevelopmentRegulatory AffairsTeam LeadershipMatrix ManagementClinical Strategy

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 position remote or does it require office work?

This information is not specified in the job description.

What are the key responsibilities of the Clinical Development Lead?

The role involves leading clinical development strategy for assets in specific indications or tumor types, managing clinical trial physicians, ensuring studies align with regulatory and quality goals, and representing Clinical Development in internal and external forums.

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 a recognition of the importance of balance and flexibility.

What makes a strong candidate for this Clinical Development Lead role?

Strong candidates are matrix leaders who lead, develop, motivate teams, demonstrate a resilient attitude, embrace change, and have experience managing clinical trial physicians while driving clinical development strategies.

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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