ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
What You Will Do:
Development of protocols for clinical studies.
Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans.
Drafting of clinical scientific documents such as IND, IND amendments, Clinical Study Reports, Investigator Brochures, Annual Reports, and other health authorities submissions.
Responsible for providing clinical input into eCRF design, SAP, and TLFs.
Monitor, review, and summarize clinical safety and efficacy data in ongoing studies.
Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends.
Will lead the clinical matrix teams for assigned studies, represent clinical development on project teams and serve as liaison to project teams, CRO's and others.
Provide clinical updates on assigned studies to Sr. management, Project Teams, Joint Project Teams and/or Steering Committees (if appropriate), Clinical sub-teams, internal strategy, and governance meetings, eDMC meetings, steering committees, advocacy groups, scientific advisory boards, and publications committees.
Liaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as needed.
Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
Contribute to writing and review of study abstracts, posters, oral presentations, and manuscripts for assigned studies.
Your Profile:
Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred.
Minimum of 4 - 6 years of experience in research with at least 3 or more years of clinical research/drug development experience are for Director level.
Experience in Immunology field is required.
Ability to multi-task and work in a fast-paced environment.
Excellent written and oral communication skills.
Strong Analytical ability.
Ability to accommodate up to 20% travelor as business dictates.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
| Location | Raleigh, North Carolina |
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