.ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.The Role:Provides scientific expertise and management oversight to drug development through all program stages:In collaboration with the ICON Therapeutic Expert, designs or reviews the product's target product profile.In collaboration with the ICON Therapeutic Expert, designs or reviews the overall product development plan, with focus on the early development path to clinical proof-of-concept, and with understanding of the medical, commercial and regulatory needs and expectations.Liaises with key opinion leaders and regulatory authorities for the challenge and improvement of draft target product profiles and (elements of) development plans, when appropriate. May act as client representative with regulatory agencies.Reviews medical and scientific literature, and reviews 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.Designs or reviews the outlines of studies in the early clinical development plan, including ADME, PK and PK/PD studies.Reviews study results and study reports.Guides the development of manuscripts and early clinical development, clinical pharmacology and/or PK/PD sections of regulatory submission documents.Develops, presents, and/or publishes innovative early clinical development, PK, PD and biomarkers strategies.Collaborates with clients on the design of drug development programs.Provides formal, in-house classroom training to PRA staff when necessary.Routinely provides departmental updates on recent developments in the field of early clinical development, clinical pharmacology, PK, PD and biomarker concepts and applications.Directs a group responsible for clinical pharmacology, PK, and PD activities, if applicable.Participates in Business Development activities and the RFP process:Proactively builds and maintains his/her network in the biotech and pharma landscape. Interacts with potential clients on own initiative if appropriate, and when requested by Business Development.Provides support to proposals for full development programs and for individual clinical studies.Provides support in the production of promotional material; (co-)authors scientificwhite papers of fact sheets.Participates in RFP bid defenses; provides client consulting at the RFP stage
