Who We Are:
Clinical development involving rare diseases poses a unique set of medical, scientific, and operational challenges. PRA understands these challenges and the critical success factors necessary to develop drugs for rare disease patients. It’s not a cookie-cutter formula, but rather a nimble and customized approach that embraces the flexibility, creativity, and innovation needed to succeed in this important area. In the last 5 years, we have managed over 200 Phase I-IV rare disease studies, across 12 different therapeutic areas, resulting in the successful marketing approval of 18 drugs. We are passionate about bringing new therapies to patients faster – and we are looking for someone to join our team who shares this passion!
Who You Are:
You are committed to helping accelerate the development of new treatments for those suffering from a rare disease. You bring a scientific orientation combined with the ability to see the big picture; you are a proactive problem-solver; you are a quick-learner; and you communicate well across varied audiences. You have strong clinical research experience, understand the clinical drug development process, and enjoy interacting with clients, patients, advocacy groups, investigators, and internal teams to collaborate on innovative strategies for complex clinical projects. You enjoy working in a fast-paced environment with a constant influx of new, interesting, and challenging projects to work on. You want to learn, absorb, grow, mentor, and to do so in an environment where you make a difference. You are savvy at marrying both the site and sponsor needs to skillfully advise on protocol development, site selection, patient pathways, and how we can reduce the burden of clinical trial participation. You are confident in your therapeutic knowledge but open to expanding and committed to continuous learning.
What You Will Be Doing:
Provide scientific, therapeutic, and drug development expertise and support across multiple therapeutic areas within the rare disease space. Leverage clinical and therapeutic knowledge and expertise to help secure new projects and support clients and project teams with opinion leader-level therapeutic guidance.
Services provided include:
• Evaluate medical informatics and other data sources to bring an evidenced-based approach to the design of rare disease clinical programs
• Identify targeted clients and support pipeline analysis to support the growth of the rare disease franchise in specific disease states
• Engage, consult, guide, and present to prospective and current clients
• Clinical development program and protocol design
• Provide therapeutic expertise support for RFPs and ongoing projects, to include: input from patients and the patient community within a specific disease area; align with colleagues in other functional groups to identify innovative strategies for the conduct of studies; identify strategies to reduce the burden of clinical trial participation amongst patients, families, caregivers as well as investigative site staff
• Project team training and support during operational delivery of clinical services
What You Need to Have:
• Bachelors Degree required; graduate degree preferred (MS, PhD)
• 10+ years experience in clinical research.
• Knowledge of, and experience with, the clinical operations at the site level
• Experience and familiarity with rare diseases; preference for expert-level experience within a particular disease area or group of disorders
• Management experience, including functional department responsibilities is preferred
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.