Senior Director, Clinical Operations

The role

The Senior Director, Clinical Operations provides strategic and operational leadership for early-stage clinical development programs. This person leads clinical operations strategy and execution for clinical pharmacology studies and Phase I/II patient studies across a portfolio of biotechnology companies.

What you will do

• Lead clinical operations for multiple early development programs across portfolio companies.
• Develop operational strategy aligned with program and portfolio priorities.
• Lead studies from protocol development through closeout.
• Lead cross-functional study teams and own the CRO and vendor lifecycle.
• Oversee study timelines, budgets, forecasts, resources, and vendor performance.
• Ensure compliance with ICH-GCP and applicable global regulations.
• Drive continuous improvement through scalable processes, SOPs, and operational best practices.
• Develop and mentor clinical operations staff and external resources.
• Champion innovative approaches to trial execution.

Required qualifications

• Bachelor's degree in a scientific discipline
• At least 10 years of progressive clinical operations experience within biotechnology, pharmaceutical, or CRO organizations
• Leadership responsibility for early-stage clinical programs
• Success leading operational execution of clinical pharmacology studies and Phase I/II patient studies
• Experience overseeing CROs and external vendors
• Understanding of clinical development strategy and early-stage drug development operational considerations
• Hands-on experience with global operational strategy
• Ability to lead multiple concurrent clinical programs
• Deep knowledge of ICH-GCP, FDA, EMA, and other applicable regulatory requirements
• Experience managing clinical trial budgets, resource planning, forecasting, and operational risk management
• Ability to build collaborative relationships across Clinical Development, Biometrics, Regulatory, Quality, and executive leadership
• Leadership, communication, and negotiation skills

Nice to have

• advanced degree

Benefits

• medical
• dental
• vision
• 401k

About the company

Aditum Bio in-licenses promising therapies that are not advancing toward the clinic. The firm focuses on the translational phase of medicine to generate data that can support full clinical development and market launch.