Director, Clinical Program Management

United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Candidates must possess a BA/BS degree in a scientific or healthcare discipline and have a minimum of 10 years of relevant clinical operations experience in the pharmaceutical/biotech industry, with at least 5 years specifically in oncology trials. Prior experience with radiopharmaceuticals, theranostics, and/or companion diagnostics is highly desirable. Strong leadership, project management skills, and expertise in Microsoft Project and Smartsheets are also required. The role necessitates independent professional who proactively communicates frequently and effectively, is detail and action-oriented, organized, committed to quality and consistency, and able to work in a dynamic environment with flexibility.

Responsibilities

The Director, Clinical Program Management is accountable for the on-time and on-budget delivery of assigned clinical study(ies) within the RayzeBio portfolio at the highest quality standards. This role will oversee all operational aspects of the clinical program in compliance with corporate SOPs, GCP/ICH guidelines, and applicable regulations. Responsibilities include developing clinical operational strategy, overseeing global clinical study teams, CROs, and vendors, managing clinical trial execution from planning to close-out, identifying and mitigating operational risks, contributing to clinical development plans and protocol design, leading cross-functional study execution teams, managing clinical study timelines, performing oversight review and quality control of CRO and vendor activities, and actively participating in CRO and vendor meetings.

Skills

Clinical Program Management

Clinical Operations

Clinical Study Design

GCP

ICH

FDA Regulations

CRO Management

Vendor Management

Budget Management

Timeline Management

Global Clinical Trials

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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