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Precision for Medicine, a Clinical Research Organization, is seeking a Director of Site Start-up to lead and expand the Site Start-up (SSU) department. This role provides strategic leadership and operational oversight of the SSU function, which manages critical activities including Informed Consent Form review and adaptation, regulatory document collection and quality assurance, IRB/EC/CA submissions support, and site contract and budget negotiations.
The Director will guide the SSU team on project delivery, communication, HR, revenue enhancement, and process optimization to meet client and departmental targets. Key responsibilities include direct management and cross-functional oversight of site start-up delivery across regulatory submissions, site contracts, and budget negotiations. The role works closely with the Head of Site Start-up to establish the SSU framework, ensuring project execution, delivery intelligence, tools, methodology, and risk mitigation.
The Director will support collaboration between SSU, Clinical Operations, project management, and other departments in planning and executing SSU activities globally and regionally. This includes managing escalations, optimizing processes for profitability, partnering with Global Resourcing teams on staffing and performance management, and supporting team career development and succession planning.
Additional responsibilities encompass coordinating SSU participation in client meetings, collaborating with Business Development on proposals and bid defense, developing and reporting SSU KPIs, and driving continuous improvement. The role requires exemplifying PFM's values around quality, people, clients, and performance while leveraging communication skills to reinforce culture and drive team engagement and retention.
Required qualifications include a Bachelor's degree in life sciences or related field, minimum 12 years in clinical research with extensive site start-up experience, proven leadership competencies, and expert knowledge of GCP/ICH guidelines and clinical development processes. Candidates should have demonstrated leadership track record, team and resource management experience, proficiency with Microsoft Office and clinical software (CTMS, eTMF, EDC), excellent communication and interpersonal skills, strong organizational abilities, and experience in strategic planning and risk management.
