Director, Site Start up

Precision for Medicine is hiring a Director, Site Start up to join our team. We can consider candidates working remotely in the UK, Spain, Poland, Hungary, Serbia, Slovakia or Romania.

Position Summary:

Provides leadership to the Site Start-up (SSU) department. Contributes to the strategy and direction of the implementation and expansion of the SSU department in terms of people, processes, and systems. Collaborates with other functions to secure SSU delivery and client satisfaction on SSU activities (typically, these include activities such as Informed Consent Form review and adaptation, Regulatory Document collection and quality review, Support to Regulatory and sites on IRB/EC/CA submissions and support to Site Contracts group in budget and contract negotiation). Works closely with the Head of Site Start Up on the ongoing development of SSU. Ensures the conduct and delivery of clinical trials in compliance with Regulatory requirements (local and regional), ICH Guidelines, Good Clinical Practices (ICH) and SOPs.

Essential Functions:

• Provides SSU team with guidance, leadership, and overall support relating to SSU project delivery, communication, human resources, revenue enhancement, procedures, systems, and processes to meet client and departmental targets.
• Supports the overall management of site start up delivery either by direct management and/or cross-functional oversight of the departments involved in the different areas of site start-up (Local/Central IRB/Ethics Committee (EC) submissions, Competent Authorities (CA) submissions, other related governing organizations/bodies, site contracts and budget negotiations, and any other start-up requirements).
• Works closely with the Head of Site Start Up to establish the Precision for Medicine (PFM) SSU framework to ensure project execution and delivery including SSU intelligence, tools, and methodology, risk evaluations, and mitigations.
• Supports SSU collaboration with Clinical Operations team, project management, and other relevant cross-functional departments in the planning, execution, and governance of SSU activities globally and/or regionally.
• Works with the Head of Site Start Up to support defined corporate and departmental business strategies for PFM.
• Acts as an ambassador for change management for the evolution of the global structure for PFM growth and expansion.
• Provides leadership and oversight on SSU programs including large programs or programs that are increasingly complex (in scope, revenue contribution, volume, and design).
• Manages escalations and remediation of SSU concerns timely and effectively.
• Supports optimization of processes and delivery with the goal of contributing to the profitability of the SSU teams to meet or exceed budget targets.
• Partners with Global Resourcing teams for assessment and management of team members (SSU leads, SSU Specialist, and Site Contract Management staff) to ensure that established cost, time, and quality goals are met.
• Supports SSU team career development, growth, and succession planning activities. Ensures compliance with company policies and procedures and other applicable regulatory guidelines.
• Supports coordination of SSU Lead’s participation in current and prospective client meetings and presentations to ensure PFM customer service is well represented.
• Collaborates with Business Development in opportunity development, proposals, and budgeting, bid defense preparation, and attendance for any SSU participants.
• Works with global/regional functional leaders to support SSU project strategy and SSU delivery.
• Supports SSU evaluations and implements required changes for all projects.
• Develops, measures, and reports SSU KPIs and leads continuous improvement.
• Recognizes, exemplifies, and adheres to PFM’s values that center on our commitment to quality, our people, clients, and performance.
• Leverages communication skills and experience to reinforce PFM culture and values to motivate, maintain engagement, and drive retention for the SSU team.