Executive Director, Clinical Development Operations

i-Pharm Consulting; United States; Hybrid; USD 150,000 - 250,000; Full time

Job summary

An established industry player is seeking an Executive Director for Clinical Development Operations in the Cardio Renal Metabolic space. This role offers a unique opportunity to lead a high-impact team and drive innovative clinical strategies. The ideal candidate will possess extensive experience in clinical operations, particularly within cardiovascular, renal, or metabolic areas, and demonstrate strong leadership and strategic planning skills. Join a globally connected organization where you will play a pivotal role in shaping the future of clinical trials and delivering life-changing therapies to patients. If you are a determined leader with an innovative mindset, this is the perfect opportunity for you.

Qualifications

• 15+ years in clinical operations with expertise in CRM therapeutic areas.
• Strong leadership and strategic planning capabilities required.

Responsibilities

• Lead clinical development operations ensuring efficiency and excellence.
• Develop clinical strategies to drive trial acceleration and innovation.

Skills

Leadership

Strategic Planning

Clinical Operations

Stakeholder Engagement

Regulatory Knowledge

Digital Transformation

Education

MD or PhD

Job description

Executive Director, Clinical Development Operations

Reporting to: Therapeutic Area Head

Location: Hybrid, U.S. (East Coast Preferred, Central allowable for standout candidates)

Summary

A leading global biopharmaceutical company is seeking an Executive Director to drive clinical development and operations in the Cardio Renal Metabolic (CRM) space. This is a unique opportunity to play a critical leadership role in delivering innovative medicines and executing best-in-class clinical programs. The role involves cross-functional collaboration, strategic execution, and engagement with external stakeholders to advance CRM clinical trials efficiently.

Responsibilities

• Lead and oversee clinical development operations for CRM, ensuring efficiency and excellence in execution.
• Develop and implement clinical strategies, driving trial acceleration and innovative methodologies.
• Direct a high-performing team of Clinical Development Operations Leads (CDOLs) supporting each asset.
• Engage with key industry stakeholders, including professional societies, academic institutions, and regulatory authorities.
• Champion digital transformation initiatives, optimizing data utilization and trial design.
• Collaborate with cross-functional teams, including Medical Affairs, Regulatory, and Translational Medicine.
• Contribute to governance and steering committees, ensuring alignment with strategic objectives.

Requirements

• MD or PhD (Required), with 15+ years of experience in clinical operations.
• Extensive experience in Cardiovascular, Renal or Metabolic therapeutic areas required.
• Strong leadership and strategic planning capabilities.
• Ability to engage with key opinion leaders (KOLs), regulatory agencies, and external partners.
• Expertise in industry standards, FDA/EMA regulations, and best practices in clinical trial execution.
• Willingness to travel as needed for conferences, investigator meetings, and stakeholder engagement.

This position is ideal for a candidate who demonstrates the following qualities:

• Strategic Leadership: Proven expertise in clinical development and operational execution within CRM or related therapeutic areas.
• Clinical & Scientific Expertise: Deep knowledge of trial design, execution, and regulatory pathways.
• Collaborative Approach: Strong ability to engage with internal and external stakeholders, including cross-functional teams, regulatory bodies, and industry partners.
• Innovative Mindset: Ability to integrate digital transformation and data-driven decision-making into clinical development.
• Entrepreneurial Spirit: Determined, agile, solution-oriented leader who can drive operational excellence and patient-centric approaches.

Why Join Us?

• Lead a high-impact clinical operations team in a rapidly evolving therapeutic area.
• Work within a globally connected, innovative organization.
• Play a strategic role in shaping the future of CRM clinical trials and bringing life-changing therapies to patients.

Seniority level

Executive

Employment type

Full-time

Job function

Science, Project Management, and Strategy/Planning

Industries

Pharmaceutical Manufacturing and Biotechnology Research