Senior Clinical Scientist

IRE • Raleigh, NC

2d

About The Position

Senior Clinical Scientist (Hematology-Oncology) 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. As a Senior Clinical Scientist at ICON, you will design and conduct clinical studies that evaluate the safety and efficacy of innovative treatments.

Requirements

• At least 5 years’ experience and a, PhD, PharmD or MD degree or at least 10 years’ experience with BS/MS degree with emphasis on early development, clinical pharmacology or a related discipline
• Ability to critically analyze problems and provide creative solutions
• Excellent written and oral communication skills
• Confidence and ability to present to and influence matrix teams and senior leaders
• Ability to work independently, manage multiple priorities, and thrive in a dynamic environment
• Genuine curiosity and drive to ask questions – looking for the ‘why’ of every project
• Early phase/Phase I experience required
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

• Experience in clinical pharmacology, immunology or oncology is preferred

Responsibilities

• Provide strategic leadership and demonstrating accountability for the clinical programs supporting early clinical development and clinical pharmacology
• Maintain updated knowledge of competitive landscape on current assets or evolving standards of care for indications of interest and provide subject matter expertise on cross-functional project teams
• Author/Review/Approve clinical protocols, analysis plans, study reports and regulatory submissions in collaboration with physicians, statisticians and other critical functions.
• Execute Clinical & Clinical Pharmacology studies in close collaboration with Clinical Operations
• Review and summarize clinical safety or efficacy data in collaboration with the Medical Monitor
• Work closely with Quantitative Clinical Pharmacology, Translational Sciences and Statistics to develop protocols and summarize analysis
• Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans
• Draft and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions
• Ensure adherence to agreed timelines and budgets to ensure prompt and accurate execution of deliverables from clinical studies and programs
• Develop and maintain collaborative working relationships with appropriate consultants and external experts for subject matter expertise and protocol development
• Compliant with departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
• Participate in project teams and serve as liaison to project teams, CRO's, Clinical sub-teams, and others
• Present data at scientific meetings, both internally and externally and author manuscripts in scientific journals

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: Senior
• Education Level: Ph.D. or professional degree