Associate Director, Clinical Operations Lead (AD COL)
The Associate Director, Clinical Operations Lead is accountable for the operational strategy and end to end delivery of assigned clinical studies and/or programs. The role leads cross functional teams in a matrix environment, ensuring high quality execution, budget and timeline adherence, effective vendor oversight, and regulatory compliance across high as well as low to moderately complex global studies.
For selected low to moderately complex studies, the AD COL may assume both strategic and day to day operational leadership, acting as both SET Leader and SET Manager.

Key Responsibilities:

• Own and drive the clinical operations strategy, providing early input into Clinical Development Plans (CDP) and study design.
• Lead cross functional study teams and ensure end to end execution from protocol development through CSR and TMF archiving.
• Serve as the primary point of contact for study related matters; manage senior internal and external stakeholders and represent ClinOps in governance forums.
• Accountable for vendor/CRO strategy, oversight, and contract alignment with Business Operations.
• Drive budget strategy, forecasts, timelines, and resource optimization; monitor and report on key study performance metrics.
• Own operational risks, issue escalation, and mitigation, and support audits, inspections, and resolution of findings.
• Define and oversee site engagement strategies, feasibility, and enrollment forecasting.
• Provide functional leadership, coaching, and mentorship across Clinical Operations; contribute to SOPs, process improvements, and knowledge sharing.
• When accountable for multiple studies or a program, ensure appropriate delegation, inter-study efficiencies, and application of learnings.
• Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations.

Essential Requirements:

• As a guide, a minimum of 10 years’ relevant clinical research (or related) experience within the pharmaceutical industry.
• Previous experience in leading and managing a team of professional staff.
• A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
• Experience in overseeing large and/or complex global clinical trials.
• Robust budget forecasting and management experience.
• Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].