Associate Director Clinical Operations

Role Summary

The Associate Director is responsible for leading a team of Global Trial Leaders and Trial Managers within the Study Management Organization, overseeing staff development and study execution. This role works closely with the Director on project assignments, workload distribution, resourcing, and prioritization, and ensures operational issues are mitigated across trials and programs. The Associate Director is accountable for the operational execution of all trials within a program.

Responsibilities

• Accountable for the delivery of the operational strategy in alignment with the Clinical Development Plan, ensuring alignment with the business goals and trial delivery objectives (including resourcing, budget, and change control) by partnering with CTWG and CDST on timeline creation. May Chair and/or support the Trial Leader in leading the CTWG for the successful execution of assigned trial/s.
• Define (for early development), or work with the Director to align on, the Operational Strategy for each trial in the program and gain governance endorsement on proposed plans
• Lead operational scenario planning and mitigate trial level risks that may impact timelines / budget.
• Ensure appropriate timely and quality oversight, and appropriately escalate issues to the Director, Quality and functional leadership.
• Ability to effectively communicate the operational strategy, and defend the operational plan and costs associated to CTWG, CDST, Director, leadership and at governance meetings as appropriate.
• Lead and ensure inspection readiness for the trial/s
• Build knowledgeable and skilled team with competencies and capabilities to successfully set up and deliver clinical trials
• Promote strong collaboration across cross-functional teams
• Setting goals in alignment with company, program, and departmental goals
• Ensure staff training on procedures and systems associated with their roles
• Develop a team that consistently achieves strong results through nurturing individual growth, effectively managing performance, and providing guidance
• For early development programs, AD may represent Clinical Operations at CDST
• Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
• Lead or participate in process improvement activities at a trial and department level as needed
• Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
• Ability to travel (expected annual average of 10% but flexibility to go over or below this as required).

Qualifications

• BS/ BA degree is required.
• Minimum 8+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company working on Phase 1-4 global clinical trials.
• 3-5 years leading end to end global clinical trials with experience in conducting Phase 3 registrational trials
• Experience in and knowledge of the pharmaceutical development process
• Excellent decision-making, analytical and strong financial management skills are essential to this position
• Ability to manage all aspects of execution of a clinical trial
• Must possess excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
• Experience in leading without authority and in multifunctional matrixed and global environments
• Strong project planning/ management, communication (written and verbal) and presentation skills
• Minimum 2+ years prior line management experience or 3+ years matrixed leadership experience required
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
• Apply project management best practices to programs. Experience in novel clinical drug development.
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.