Who We Are:
We Are PRA.
We are 16,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
The Scientific Affairs-Clinical Pharmacology team is responsible for providing clients and the internal organization with scientific support in the design, conduct and reporting of early clinical development and clinical pharmacology programs, and the underlying individual clinical studies. The department maintains intensive relationships with clients, the scientific community, regulators, key opinion leaders, and subcontractors such as specialty labs. The department advises internally and externally about program and study design, and research models. It monitors scientific and medical developments, and takes the lead to incorporate these in programs and supports their practical implementation. The department is a key function in PRA’s objective of ‘Leading with Science’ through the application of a wide range of clinical pharmacology, pharmacokinetic, and pharmacodynamic expertise to drug development programs, study protocols, and regulatory filing packages.
Who You Are:
As a PharmD, MD or PhD, you have five to ten years of experience in and a passion for Early Drug Development and Protocol Design. You have had an emphasis in clinical pharmacology and pharmacokinetics. You have planned, supervised, implemented and monitored the clinical pharmacology, PK and PD development and reporting processes for clinical trials. You have excellent communication skills with demonstrated leadership ability and are comfortable making presentations.
Confident in your experience and understanding of early clinical development, you want to find a work/life balance that lets you pursue your career passion and still be, well, you. Most of all, you want to do it in a place where you’re part of a team of experts as zealous about their work as you are. A place where you can really make a difference!
What You Will Be Doing:
As a Director of Clinical Pharmacology, you’ll be providing scientific expertise and management oversight to drug development through all program stages. You will design / review the product’s target product profile with a focus on the early development path to clinical proof-of-concept, and with understanding of the medical, commercial and regulatory needs and expectations.
Additionally, you’ll be liaising with key opinion leaders and regulatory authorities for the challenge and improvement of draft target product profiles and development plans. You’ll focus on complex programs, including those therapeutic areas with little or no clinical development precedence.
You’ll also be participating medical and scientific literature review, and review preclinical and clinical safety and efficacy data of novel compounds including Investigator’s Brochure, if available, for the support of the design of clinical development programs and studies. You’ll design or review the outlines of studies in the early clinical development plan, including ADME, PK and PK/PD studies and review study results and study reports. You’ll prepare or review, and guide on the delivery of relevant sections of Statistical Analysis Plans, PK/PD data analysis and statistical results, and PK/PD sections of Clinical Study Reports. You will support the writing of clinical study protocols and study reports, and lead the writing when appropriate.
Furthermore, you may act as a client representative with regulatory agencies, participate in Business Development activities and the RFP process (bid defenses, client consulting, support for full development programs and individual clinical studies). You will guide the development of manuscripts and early clinical development, clinical pharmacology and/or PK/PD sections of regulatory submission documents.
What You Need to Have:
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.