Director, Site Start Up

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

Due to our continued growth we are seeking a Director, Site Start Up

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 of the job include but are not limited to:
• 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 depts 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 evolution of global structure for PFM growth and expansion

• Provide leadership and oversight on SSU programs including large programs or programs that are increasingly complex (in scope, revenue contribution, volume and design)