The Associate Director, Resource and Process Management is a key role for driving operational excellence, business process improvement and enabling effective clinical trial execution across Global Clinical Development Operations (GCDO). Responsible for resource planning across Clinical Operations roles, along with the hiring and line management of Clinical Trials Specialists. Ensures a consistent approach to staff development and performance management such that direct reports are equipped with the appropriate skills and capabilities to successfully lead and deliver clinical studies. 

Under the direction of the Senior Director, Clinical Operations Strategy and Excellence, the Associate Director, Resource and Process Management will coordinate the provision of Clinical Operations subject matter expertise in relation to the refinement and review of GxP processes, templates, guidelines and work instructions owned by Clinical Operations. Acts as a change agent to ensure consistent implementation of updates to processes and systems related to the delivery of clinical trials.

Essential Functions

Leadership, Resource Oversight and People Management

• Partner with Program Leads and Therapeutic Area Resourcing Leads to ensure clarity of resource and capability demand relative to supply.  

• Recruit, retain and develop the Clinical Trial Specialists, ensuring effective support to study teams across all phases of clinical trials.

• Define role expectations, develop training programs and create professional development pathways for Clinical Trial Specialists and other operational staff.

• Central management of Clinical Operations job descriptions.

• Foster a culture of learning and continuous skill development throughout the GCDO organisation.

• Build, lead and inspire a high-performing team focused on operational excellence, strategic business support and financial discipline.

• Promote a culture of collaboration, accountability and innovation.

• Role model and embed a high-performance culture and coach staff for optimum performance.

• Manage performance, including feedback and rewards.

• Provide expertise to direct reports to support proactive risk identification and issue resolution in relation to portfolio projects

Process Excellence and Continuous Improvement

• Drive continuous improvement initiatives to ensure streamlined and scalable processes, templates and workflows that contribute to reduced cycle times and improvements in quality and compliance.

• Coordinate the provision of Clinical Operations subject matter expertise in relation to the refinement and review of GxP processes, templates, guidelines and work instructions owned by Clinical Operations.

• Provision of subject matter expertise (as appropriate).

• Lead change management efforts to ensure adoption and sustainability of business process and organisational changes.

• Ensure that key business systems are fit for purpose and appropriately utilised (e.g., CTMS, resource management, budgeting tools, Planisware and financial oversight tools). 

Minimum Requirements

• Bachelor’s degree required; related experience in the pharmaceutical or biotechnology industry.

• Proven track record of driving operational excellence, managing budgets and leading cross-functional initiatives in a clinical development setting.

• Strong understanding of clinical trial processes, ICH/GCP guidelines and regulatory requirements. 

• Excellent leadership, communication and interpersonal skills.

• Proficiency in project management, change management and metrics/KPI development.

• Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations.

• Demonstrated experience managing and mentoring clinical team members.

• Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.

• International experience is highly preferred.

• Ability to work on and solve complex problems.

• Ability to prioritize and handle multiple tasks simultaneously.

• Effective leadership skills and proven ability to foster team productivity and cohesiveness.

• Excellent communication/interaction skills and experience in a dynamic and growing organization.

• Travel Required