Associate Director Clinical Operations

Summary of Key Responsibilities:
- Lead a team of Global Trial Leaders and Trial Managers; drive staff development and study oversight.
- Deliver the operational strategy aligned with the Clinical Development Plan, partnering with CTWG and CDST for timeline creation; ensure alignment with business goals and trial delivery objectives (including resourcing, budget, and change control).
- Define and/or align on operational strategy for each program trial (early development) and gain governance endorsement.
- May chair and/or support Trial Leader in leading the CTWG for successful execution.
- Lead operational scenario planning; mitigate trial-level risks impacting timelines/budget.
- Provide timely, high-quality oversight; escalate issues to Director, Quality, and functional leadership.
- Communicate and defend operational strategy, plans, and associated costs in governance meetings.
- Ensure inspection readiness for assigned trial(s).
- Build and develop a capable team; set goals aligned to company/program/department goals.
- Ensure staff training on relevant procedures and systems; nurture growth and manage performance.
- Serve as Clinical Operations representative at CDST for early development programs.
- Interface with key internal stakeholders (e.g., Finance, Program Management, Vendor Management, Safety, Quality Assurance, Data Management, Statistics, Clinical Research, Regulatory, etc.).
- Lead/participate in process improvement; support Health Authority Inspections and internal QA audits.
- Travel: expected average of 10% annually (flexible as needed).

Qualifications:
- BS/BA required.
- 8+ years clinical research experience (CRO/biotech/pharma) on Phase 1–4 global clinical trials.
- 3–5 years leading end-to-end global clinical trials, including Phase 3 registrational experience.
- Knowledge of pharmaceutical development process; strong decision-making, analytical, and financial management skills.
- Experience managing all aspects of clinical trial execution.
- Excellent leadership; ability to operate with limited supervision; leadership in matrix/global environments and leading without authority.
- Strong project planning/management, written/verbal communication, and presentation skills.
- 2+ years line management or 3+ years matrixed leadership experience.
- Exceptional organization; ability to manage competing priorities and solve problems.
- Apply project management best practices; experience in novel clinical drug development.
- Proficient with MS Office (Excel, Word, PowerPoint) and MS Project.