Premier Research is looking for a Clinical Lead III (Rare Disease) to join our Global Clinical Management team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech™. Join us and build your future here. What You'll Be Doing

• Acts as a leader driving global study and/or program clinical team and departmental engagement, maximizes the efficiencies of the clinical team across studies/program
• Oversight of clinical team tracking and analysis of open action items, protocol deviations and communication reports
• Completes/contributes to the review of the protocol/study design, informed consent forms, case report forms, and other study documents/plans, or delegates to the assigned CL
• Applies a risk-based quality management mindset, contributes to the risk management plan, and supports set up of adaptive risk monitoring system with the study team as applicable
• Works with all functional leads and sponsor to identify data related issues and risks to clinical activities; assists CLs in the development of mitigation plans to minimize risk
• Supports the PM, regional CLs, and/or appropriate line managers to ensure team members are adequately resourced to the project for the entire duration of the study
• Oversight of financial health of clinical activities including support with identifying out-of-scope tasks from the Premier clinical team and ensures pre-approval of these tasks by the PM and Sponsor, as required

What We Are Searching For

• Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience
• 9 years of clinical research experience as a CRA, CL or PM of which at least 4 years of clinical monitoring experience is required
• 4 or more years of previous Clinical Oversight/Trial Management experience, global experience valued
• Rare disease study experience is required, with preference for additional Cell & Gene Therapy experience
• Experience with presenting at bid defense meetings highly prioritized
• Experience with study start up-related activities for site activation preferred