Director, Clinical Research Scientist

IRE • Raleigh, NC

1d

About The Position

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.

Requirements

• Degree in scientific /life-sciences field.
• 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% travel or as business dictates.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

• Pharm.D. or Ph.D. preferred.

Responsibilities

• 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.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree