Director of Clinical Pharmacology
- Experience Level
Who are we?
We Are PRA Health Sciences.
We are 16,000+ employees strong, operating in more than 90 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 are you?
As a PhD or PharmD, you have five to ten years of experience in industry 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 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 and guiding clients towards realistic goals/endpoints.
You are a Director of Scientific Affairs or Clinical Pharmacology. 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 will you be doing?
As a Director of Clinical Pharmacology you will be providing scientific expertise and management oversight to drug development through all program stages focusing on the design of clinical phase 1 and regulatory clinical pharmacology studies. 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 of preclinical and clinical safety and efficacy data of novel compounds including Investigator’s Brochures, 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 occasionally 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 do you need to have?
- Ph.D. in Pharmaceutical Sciences or a health related field with emphasis in clinical pharmacology, pharmacokinetics (including ADME, biopharmaceutics, and pharmacometrics) and associated publications in peer-reviewed international journals.
- Clinical pharmacology experience in the setting of (bio)pharmaceutical or biotechnology companies.
- Demonstrated ability to plan, supervise, implement, and monitor the clinical pharmacology, PK and PD development and reporting processes for clinical trials.
- Excellent communication skills with demonstrated leadership ability.
- > 10 years of working experience at large pharmaceutical company and/or small biotech.
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com