Sr. Director, Clinical Program Management 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

Pharmaceuticals, BiotechnologyIndustries

Requirements

BA/BS degree, scientific or healthcare discipline preferred
Minimum 12 years relevant clinical operations experience in pharmaceutical/biotech industry, with at least 7 years in oncology trials
Prior experience in development programs with radiopharmaceuticals, theranostics and/or companion diagnostics highly desirable
Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making
Independent professional who proactively communicates frequently and effectively
Detail and action-oriented, organized and committed to quality and consistency
Ability to work in a dynamic environment with a high degree of flexibility
Expertise in Microsoft Project and Smartsheet
Up to 20% travel required

Responsibilities

Develop and lead the clinical operational strategy for complex, global programs, setting direction for clinical study teams, CROs, and vendors to ensure study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs and ICH/GCP guidelines
Provide senior oversight and guidance for all operational aspects of clinical trial execution, including planning and feasibility, start-up, conduct, close-out, and reporting
Identify, assess, and proactively manage operational risks and develop mitigation strategies at the program level
Contribute to and provide input on clinical development plans, protocol design, and overall program strategy
Lead and mentor cross-functional study execution teams, ensuring clarity of objectives and accountability for delivery of studies and program goals
Drive management of clinical study timelines, milestone achievement, and regular tracking/reporting of progress to executive leadership
Escalate and resolve critical program issues efficiently, ensuring timely communication to key internal stakeholders and executive leadership
Oversee quality control and performance oversight of CROs and vendors; ensure compliance with performance metrics and inspection readiness
Lead CRO and vendor governance meetings; review operational plans, performance data, and escalate study/program risks as needed
Champion process improvement initiatives to optimize operational effectiveness across programs
Perform additional related duties as assigned

Skills

Clinical Program Management

GCP

ICH Guidelines

SOPs

CRO Management

Vendor Management

Clinical Operations

FDA Regulations

Global Clinical Studies

Program Strategy

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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