Associate Director Clinical Operations

Overview/Responsibilities:
- Lead a team of Global Trial Leaders and Trial Managers; accountable for staff development and study oversight.
- Work with the Director on project assignments, workload distribution, resourcing, and prioritization.
- Accountable for operational execution of all trials within a program; influence trial objectives.
- Deliver operational strategy aligned with the Clinical Development Plan and business goals; partner with CTWG and CDST on timeline creation (incl. resourcing, budget, and change control).
- May chair/support Trial Leader in leading CTWG for successful trial execution.
- Define (early development) and/or align on Operational Strategy for each trial; obtain governance endorsement.
- Lead operational scenario planning and mitigate trial-level risks impacting timelines/budget.
- Provide timely/quality oversight; escalate issues to Director, Quality, and functional leadership.
- Communicate and defend operational strategy, plan, and costs at governance meetings.
- Ensure inspection readiness; lead inspection readiness and participate in Health Authority Inspections and internal QA audits.
- Build a skilled team; set goals aligned to company/program/department; ensure staff training; nurture growth, manage performance, and provide guidance.
- Promote cross-functional collaboration; may represent Clinical Operations at CDST for early development.
- Interface with internal stakeholders (e.g., Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs).
- Lead/participate in process improvement activities.
- Ability to travel ~10% annually (flexible as required).

Qualifications:
- BS/BA required.
- 8+ years clinical research experience (CRO/Biotech/Pharma) on Phase 1–4 global trials.
- 3–5 years leading end-to-end global clinical trials; Phase 3 registrational experience required.
- Knowledge/experience in pharmaceutical development process.
- Strong decision-making, analytical, and financial management skills.
- Ability to manage all aspects of clinical trial execution.
- Excellent leadership; foster productivity/cohesiveness; operate with limited supervision.
- Experience leading without authority in global, matrixed environments.
- Strong project planning/management, written/verbal communication, and presentation skills.
- 2+ years line management or 3+ years matrixed leadership experience.
- Exceptional organizational skills; reasoning and problem-solving.
- Apply project management best practices; experience in novel clinical drug development.
- Proficient in MS Office (Excel, Word, PowerPoint) and MS Project.