Principal Manager, Clinical Operations Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the execution of clinical trials and ensure operational delivery by collaborating with both internal and external stakeholders from the initiation of the study through its execution.

• Monitor CROs, vendors, and clinical trial partners to guarantee that quality, compliance, timelines, and budget goals are met.

• Act as the Clinical Operations lead for a team comprising CTMs, CRAs, and CTAs for each designated project.

• Facilitate the identification of risks, escalation of issues, and planning of mitigation strategies across assigned studies.

• Assist in study initiation, site feasibility assessments, enrollment, and execution of operational activities.

• Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Safety, Biometrics, Supply Chain, Program Leadership, and external partners.

• Contribute to the development of SOPs, process improvements, inspection preparedness, and initiatives aimed at operational excellence.

• Provide mentorship and coaching to junior members of the Clinical Operations team as necessary.

⛳️ Requirements

• Bachelor’s degree in life sciences, nursing, or a related field.

• Over 7 years of proven leadership in global clinical operations within the pharmaceutical or biotechnology sectors, including oversight of clinical trials, vendor management, and cross-functional leadership.

• Master's degree, ideally in life sciences, nursing, or a similar discipline.

• Recognized experience in late-phase or launch activities within oncology.

• Experience with cell and/or gene therapy or other complex biologic clinical development programs.

• Proven track record of driving process improvements and initiatives aimed at operational excellence.

• Ability to comprehend and navigate intricate clinical development processes and interdependencies across functions, collaborating effectively with stakeholders outside of Clinical Operations.

• Strong analytical and problem-solving skills with a capacity to evaluate operational impacts across broader cross-functional contexts.

• Capability to function efficiently in a dynamic and fast-paced clinical research environment.

• Must have authorization to work in the United States without requiring current or future sponsorship.

• Successful completion of a background check, reference checks, and pre-employment drug screening, where allowed by applicable law.

🏝️ Benefits

• Competitive rates for Health, Dental, and Vision Insurance.

• 4 weeks of vacation, awarded upfront each year and prorated for the first and last year of employment.

• 12 company-paid holidays.

• 7 days of sick leave.

• 100% employer-covered life insurance up to 1x annual salary, capped at one hundred thousand dollars.

• 100% employer-funded short- and long-term disability coverage.

• 401(k) plan with immediate eligibility and company matching.

• Partially paid parental leave for eligible employees.

• Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance.