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)
• Manage 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
• Partner 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
• Develop, measure and report SSU KPIs and lead continuous improvement
• Recognize, exemplify, and adhere to PFM’s values that center on our commitment to quality, our people, clients and performance
• Leverage communication skills and experience to reinforce PfM culture and values to motivate, maintain engagement and drive retention for SSU team
Requirement :
• Bachelors degree in life sciences or related field or equivalent combination of education, training, and experience.
• A minimum of 12 years in clinical research including extensive experience of Site Start-up
• Extensive leadership experience or proven competencies for this position.
• Expert knowledge of GCP/ICH guidelines and the clinical development process.
Other Required:
• Demonstrated leadership track record
• Experience working in team environment with resource management experience
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and clinical software experience (CTMS, eTMF, EDC etc)
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Proven experience in strategic planning, risk management and change management
• Fluency in English.
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
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Skills Required
- Bachelor's degree in life sciences or related field (or equivalent)
- Minimum 12 years clinical research experience including extensive Site Start-up experience
- Extensive leadership experience or proven leadership competencies
- Expert knowledge of GCP/ICH guidelines and the clinical development process
- Demonstrated leadership track record and people management experience
- Experience working in team environments with resource management responsibility
- Experience with Microsoft Office (Outlook, Word, Excel, PowerPoint)
- Experience with clinical systems (CTMS, eTMF, EDC)
- Excellent communication and interpersonal skills
- Excellent organizational skills, attention to detail, and customer service orientation
- Proven experience in strategic planning, risk management and change management
- Fluency in English
Precision Medicine Group Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Precision Medicine Group and has not been reviewed or approved by Precision Medicine Group.
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Healthcare Strength — Health coverage includes medical, dental, and vision with HSA/FSA options, plus disability and life insurance, forming a comprehensive core package. The lineup is presented as robust across wellbeing, time off, and financial security categories.
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Leave & Time Off Breadth — Time off includes generous PTO and paid holidays, along with paid parental leave and adoption assistance. These offerings are positioned as part of a well-rounded benefits suite in the U.S. with similar cores noted in Canada.
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Retirement Support — Retirement programs include a 401(k) with employer match in the U.S. and a group retirement plan in Canada. These elements help establish a competitive total rewards foundation.
Precision Medicine Group Insights
What We Do
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.
