Senior Clinical Scientist - Infectious Disease (HIV)

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 be doing:

May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol.
As lead, will be responsible for the following:
Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)
Responsible for trial design and endpoint development in collaboration with CD
Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports
Sets up/supports SAC, DMC, adjudication committees
Protocols/amendments – collaborates with medical writer, participates in governance committee review
Authors protocol clarification letters
Contributor to study specific documents (e.g., SMP)
Reviews/updates informed consent
Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)
Monitors data issues requiring clinical input
Monitors central lab reports and other external data for safety and critical values
Prepares scientific slides, attends and presents protocol information at Investigator Meeting
Scientific lead on Clinical Trial Team (CTT)
Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system
Coordinates planning of lab, bio specimens and imaging specifications
Co- authors newsletters with SM
Participates in Database lock activities Collaboratively plans CSRs, CTDs/WMAs with medical writing
Supports publications/presentations as needed
Reconciles and review all protocol deviation classifications in SPECTRUM
Assesses and prepares protocol deviation list for CSR
Collaborates with medical writing to develop trial results communication for investigators
Provides scientific assessment for Operational Reviews
Supports SM/MW activities as needed to achieve CTT deliverables.
Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)
May act as mentor to other CSs

What you need to have:

Educational Requirements

BS/BA in Life Sciences with 7+ yrs clinical research experience
MS/PhD in Life Sciences with 5+ years clinical research experience
If no degree in Life Sciences, must have significant experience in clinical development (>11 years)

Minimum Years of Experience

Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead CS required.
Medical monitoring experience required
Infectious Disease experience required. HIV experience highly preferred.
Excellent Excel and PP skills required
Excellent written and oral communication skills
Ability to travel up to 15% (might include international travel)
To qualify, applicants must be legally authorized to work in the Canada or US, and should not require, now or in the future, sponsorship for employment visa status

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:

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

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.

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