Clinical Operations Program Lead

Role Overview

• Provide program leadership for clinical operational strategy and deliverables
• Collaborate with the Sr. GPD or (Associate) Director of Clinical Operations Program in determining possible program design options
• Provides strategic oversight and feasibility input into the design of the clinical program
• Collaborate with cross functions to establish strategies and identify synergies aimed at increasing operational efficiency to enable successful study delivery
• Incorporate digital health and patient centric strategies into clinical studies to balance scientific intention and operational efficiency
• Provides an accurate budget forecasting, maintenance, and monitoring to baseline, clinical program resourcing, scenario planning, plus overall timelines for trials within assigned program, including setup and maintenance within Company systems
• Developing and managing of contingency risk plans within each assigned clinical program, including management of program issue escalation and resolution
• Accountable for ensuring timely compliance with company-wide governance controls
• Leads operational discussions with external experts/entities, including key opinion leaders, regulatory agencies, and other external collaborators to ensure robust operational design and execution
• Responsible for the overall program management of a number of studies delivered by global study leaders, by overseeing quality, budget, resource, timelines and risks, identifying synergies aimed at increasing operational efficiency and providing the team with direction and guidance to enable successful study delivery

Requirements

• Bachelor degree or above in medical, pharmaceutical, biological science or healthcare
• 8-10 years within pharmaceutical industry or similar biotech industry, including 2 years global and study-level project management experience
• Proven global experience of clinical development/drug development process across various phases in R&D
• Excellent communication skills, including negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization
• Integrity and high ethical standards
• Higher degree e.g. PhD, MD, PharmD (desirable)
• Project management certification (desirable)
• Experience of early phase clinical delivery (desirable)
• Experience of incorporating digital health and patient centric strategies into clinical studies (desirable)
• Regulatory submission experience (desirable)

Benefits

• Equal opportunity employer
• Inclusion and diversity programs
• Commitment to lifelong learning, growth, and development