Principal Manager, Clinical Operations Lead

About the role

We are seeking a Principal Manager, Clinical Operations Lead to support our Clinical Operations team. The Clinical Operations Lead will be responsible for the oversight, execution, and operational management of US regional clinical trials in support of our clinical development programs. Reports to: Associate Director, Clinical Asset Management. Location: US, Fully Remote.

Responsibilities

• Lead clinical trial execution and operational delivery across internal and external stakeholders from study start‑up through execution
• Provide oversight of CROs, vendors, and clinical trial partners to ensure quality, compliance, timelines, and budget objectives are achieved
• Serve as the Clinical Operations leader for the team of CTMs, CRAs and CTAs for each assigned project
• Drive risk identification, issue escalation, and mitigation planning across assigned studies
• Support study start up, site feasibility, enrollment, and operational execution activities
• Partner cross‑functionally with Clinical Development, Regulatory, Safety, Biometrics, Supply Chain, Program Leadership and external vendors
• Contribute to SOP development, process optimization, inspection readiness, and operational excellence initiatives
• Mentor and coach junior Clinical Operations team members as applicable

Requirements

• Bachelor’s degree in life science, nursing, or similar
• 7+ years of demonstrated leadership of global clinical operations in the pharmaceutical or biotechnology industry including clinical trial oversight, vendor management, and cross‑functional study leadership

Qualifications

• Master’s Degree, preferably in life science, nursing, or similar
• Noted experience in late phase or launch in oncology
• Experience in cell and/or gene therapy, or other complex biologic clinical development programs
• Demonstrated ability to drive process improvements and operational excellence initiatives
• Ability to understand and navigate complex clinical development processes and cross‑functional interdependencies and collaborate with stakeholders outside of Clinical Operations
• Strong analytical and problem‑solving skills with the ability to assess operational impact across broader cross‑functional environments
• Ability to operate effectively in a fast‑paced and evolving clinical research environment

Skills

Strong analytical and problem‑solving skills; ability to drive process improvements and operational excellence initiatives; ability to understand and navigate complex clinical development processes and cross‑functional interdependencies; ability to operate effectively in a fast‑paced and evolving clinical research environment; mentoring and coaching junior team members.

Benefits

• Competitive rates for Health, Dental, and Vision Insurance
• 4 weeks of vacation, granted up front each year and prorated for first and last year of employment
• 12 company paid holidays
• 7 days of sick time
• 100% employer‑paid life insurance up to 1× annual salary, up to $100,000
• 100% employer‑paid short‑ and long‑term disability coverage
• 401(k) with immediate eligibility and company match: 100% match of contributions up to 3% of base salary for first two years, 4% for years 2‑3, and up to 5% from year 4 onward
• Partially paid parental leave for eligible employees
• Additional voluntary employee‑paid benefits and services, including accident, hospital indemnity, and critical illness insurance, identity theft protection, and pet insurance

Pay

Salary Range: $165,000 – $180,000