PPD Clinical Research and Drug Development Fellowship
This fellowship is sponsored in collaboration with PPD and is part of the DPET fellowship program.
- Application deadline: December 15, 2020
- Length: Two years
This postdoctoral fellowship program provides training and experience in the conduct of clinical drug trials, participation in clinical research projects under the direction of a UNC faculty member and an industry preceptor, didactic instruction in courses that supplement training and professional interests, and exposure to ethical, legal, and regulatory issues in research involving investigational and marketed drugs. Fellows participate in clinical research studies with faculty at the UNC Eshelman School of Pharmacy during the first year of appointment, and with members of a drug development clinical research group (phases I–IV) at PPD in the second year.
The ideal candidate should have a PharmD, PhD, or MD and possess strong analytical skills, excellent written and verbal communication skills, good organizational abilities, and evidence of leadership and team work.
Fellows will spend the first year at the University of North Carolina at Chapel Hill and will have the opportunity to:
- participate in an original clinical research project under the direction of a clinical faculty member;
- develop a protocol, recruit and monitor patients or subjects, coordinate clinical studies, collect and analyze data, and prepare a manuscript; and
- gain experience with analytical methodologies, PK/PD, and pharmacogenomics; and
- participate in selected coursework in clinical research methods, clinical study design, biostatistics, advanced PK/PD, genomics, advanced therapeutics, drug metabolism and molecular biology.
Fellows will spend the second year in PPD offices, primarily at the Morrisville, North Carolina campus located in Research Triangle Park.
Based on the company model, the second year of the fellowship will take into account the fellows’ strengths and skills to maximize their experience with current and future business needs. Fellows will have a broad experience and will be exposed to many departments during several rotations (either sequential or parallel) that will be customized and adaptable based on each fellow’s interest areas.
The duration of each rotation is flexible and may be longitudinal depending on the fellow’s area of focus. An introductory rotation will allow fellows to gain a basic understanding of PPD’s core business.
Introductory Rotation: CRO Orientation/Operations
- Orient the fellow to all aspects of this full service CRO, including services provided (e.g., IND to NDA to post-market projects, proposal writing and development, contract preparation, budget development, and bid defense)
- Complete Clinical Foundation Training or equivalent training necessary to complete projects successfully
- Meet with the different departments within PPD
- Gain familiarity with PPD’s corporate environment and general operations of a CRO
- Become familiar with PPD’s different departments and their role within the organization
- Obtain basic understanding of business development process within PPD
- Clinical development/project management
- Global product development
- Global regulatory affairs
- Global strategic proposal development
- Pharmacovigilance (safety)
- Gain broad experience in many departments within PPD, potentially in a therapeutic area of interest
- Work on an interdisciplinary team to consult on client development programs from Phase I to Phase IV
- Provide medical support and drug information to global product development physicians and pharmacists or regulatory affairs professionals
- Conduct market analysis and competitive intelligence
- Complete a clinical trial landscape analysis of a disease state and/or drug class
- Experience all aspects of being a member of a clinical project team dedicated to clinical study within a therapeutic area of interest
- Assist in the project-specific training activities for the clinical project team (e.g., seminars)
- Work independently as associate/co-project manager and lead activities of the clinical development team
- Gain experience in investigator recruitment and feasibility
- Review and process regulatory documents, including Case Report Form (CRF) design/protocol review
- Witness site monitoring visits for clinical sites according to FDA regulations and PPD SOPs
- Become trained as a clinical pharmacologist in the pharmaceutical industry setting
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 12,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.
PPD has offered the Drug Development and Clinical Research Fellowship since 1997 and has provided extensive training opportunities in different arenas of clinical research.
Visit http://pharmacydpetfellowships.web.unc.edu/ for instructions on submitting an application.
Application Opens: September 8, 2020
Early Consideration: October 30, 2020
Final: December 15, 2020
After you apply, you will receive a confirmation email once your application has been submitted. Following review, you may be invited to interview at UNC and fellowship sponsors. Fellowship interviews begin in early December and typically conclude in January. You will be notified of the final disposition of your application as soon as possible.
Information interviews may be arranged for the ACCP Annual Meeting and the ASHP Midyear Clinical Meeting. These meetings will be held virtually this year. Please continue to check the website for further details.
Contact for Program Information
Clinical Professor of Pharmacy and Director of Fellowship Programs
3213 Kerr Hall, CB# 7569
Austin Combest, PharmD, MBA
Clinical Scientist and Fellowship Director