Medical Director-Early Clinical Development

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.

What you will be doing?

• Act as the Early Clinical Development Lead on cross-functional, multiregional, matrix project teams and/or clinical subteams.
• Participate in the development of early clinical development plan to support the transition of new product candidates from preclinical to first-inhuman, as well as product life cycle management strategies.
• Work with other functional disciples to ensure the full scope and remit of early clinical development is represented as needed within clinical study teams. Partner with Translational Research and Global Clinical Lead as needed to ensure that translational medicine plans are enabled in relevant therapeutic area programs.
• Lead cross-functional team to drives the synopsis/protocol development for clinical pharmacology and early phase clinical studies in healthy subjects or patients.
• Act as the Clinical Lead and/or Medical Monitor during the execution phase of studies. Serve as technical resource for clinical issues raised by internal and external collaborators and investigators. Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Conducts data review, analysis, and interpretation of clinical trials data together with the Global Clinical Lead, Clinical Safety, Biostatistics and other relevant functional leads.
• Support the development and review of clinical and regulatory documents, including clinical development plan, IND, regulatory briefing book, Annual Report, investigator brochure, statistical analysis plan and others.
• Represent Clinical Pharmacology & Early Clinical Development in the relevant interactions with regulatory agencies as well as advisors/experts in the related therapeutic areas.

What do you need to have?

• MD or internationally recognized equivalent degree with 5 years of clinical research/drug development experience, or Ph.D./Pharm. D with 10 years of pharmaceutical industry experience is required.
• Previous experience in early clinical development with clinical trial experience in clinical pharmacology and early phase clinical studies is required
• Good understanding of Clinical Pharmacology principles and PK/PD knowledge is highly recommended. Experience in biologics and familiarity with related disciplines (biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences) is preferred.
• Experience in regulatory interaction and submission is desired.
• Excellent communication and scientific writing skills and working experience on matrix teams are required.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.