Principal Clinical Lead (Rare Disease)
Description
Premier Research is looking for a Principal Clinical Lead to join our 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 BiotechTM. 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
- 10 years of clinical research experience as a CRA, CL or PM of which at least 4 years ofclinical monitoring (or related) experience is required
- 5 or more years of previous Clinical Oversight experience or equivalent (PM-CL), with priority for rare disease and cell & gene therapy trial management experience
- Provided guidance, mentoring and training for Clinical Leads on a global study and/orprogram clinical program
- Supported clinical staff as a Subject Matter Expert for processes, systems, or tools
- Expert presentation skills, including bid defense experience
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.