Associate Director/Director, Clinical Delivery Capabilities - EMP

Study Development and Execution Support: 

• Establish networks with other key support areas to efficiently and effectively support exploratory and biopharmaceutics clinical studies. The team will support study development by owning updates to corporate systems and processes e.g. CT Registry, Vault Clinical; trial and compound level documentation management e.g. eTMF and the contracting elements for a study.   

• Provide leadership in business interactions with TPO partners; helping to implement the exploratory and biopharmaceutics clinical development portfolio.  Lead and partner in the issue customer concern and relationship management processes, vendor and clinical research unit assessments as appropriate.  

• Maintain awareness of regulatory issues and trends relevant to assigned portfolio. 

Systems and Processes Support: 

• Provide leadership in business processes supporting early phase development. 

• Established expertise on key business systems that support exploratory and biopharmaceutics clinical development. 

• Review of established procedures across multiple subject areas, dependent on the change agendas to be evaluated and prioritized.  Contribute to the overall strategic direction of cross-functional systems and process  

• Draw on deep exploratory and biopharmaceutics clinical development knowledge and process expertise to review processes and when vital, sponsor improvement initiatives to increase business efficiency and value. 

• Ensure cross-functional process alignment internally and externally where appropriate 

• Act as a key resource to internal governance committees regarding processes applied in the exploratory and biopharmaceutics clinical development 

• Ensure optimal network with the Quality, Clinical Information and Process Automation, and L&D organizations is established in order to guarantee processes deliver on Quality and Regulatory compliance requirements. 

• Lead organizational change initiatives to ensure successful adoption of new clinical delivery capabilities, systems, and processes. 

• Lead and collaborate with cross-functional teams to assess change impacts, develop communication strategies, and coordinate delivery of training. 

• Act as a change advocate, helping collaborators navigate transitions and embedding change into team culture and workflows 

Systems, Metrics and Reporting: 

• Drive definition of metrics or measures to quantify exploratory and biopharmaceutics clinical development portfolio results and assess process effectiveness 

• Develop a metrics / measures and evaluation strategy for the organization.  Establish and operationalize the processes to support this strategy e.g. scorecard generation 

• Drive identification and development of emerging technologies to support the advancement of medicines to the clinic.  e.g. Artificial Intelligence tools 

• Review the implementation progress of implemented systems and/or recommend corrective actions, if needed. 

People Management and Employee Development:  

• Attract, retain and develop a diverse workforce.   

• Model behaviors and establish an environment where performance and results are valued, and where individuals are learning and growing developmentally. 

• Seek opportunities to reward and recognize individuals and teams. 

• Provide supportive environment for staff to explore innovative solutions to business problems and implement strategic and tactical decisions. 

• Contribute to succession planning, talent assessment and performance/promotion processes.  Ensure high talent staff are appropriately rewarded and developed. 

• Coach and mentor department personnel, and as needed, cross-functional members, in order to affect development and growth of all team members. 

Minimum Qualification Requirements: 

• Bachelor’s degree in a science related field from an accredited college or university; or equivalent qualifications/experience (3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies,

• Project management and time management skills. 

• Experience working cross-culturally and in a virtual work environment. 

• Ability to travel (up to 10% expected – varies dependent on responsibilities) 

Other Information/Additional Preferences: 

• Advanced scientific degree 

• Ideally in exploratory and bio-pharmaceutics clinical development (5+ year preferred)). Solid understanding of regulations and guidelines that apply to the conduct of clinical trials. 

• Direct supervisory experience  

• Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships. 

• Strong organizational and interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups. 

• Strong verbal reasoning, attention to detail, critical thinking, problem solving, and analytical abilities.  

• Proven experience of coaching and mentoring others. 

• Deep expertise in one or more clinical research functions (clinical operations, sourcing, data sciences) 

• Vendor management and contracting experience.  

• Exploratory and biopharmaceutics clinical development, quality and Six Sigma experience preferred. 

• Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates). 

• Demonstrated experience in Organizational Change Management (OCM), with a strong ability to lead teams through transitions involving new systems, tools, or process changes.