FSP Scientist - Precision Medicine

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

The Scientist, Precision Medicine is a hands-on scientist who drives the day-to-day execution of local testing and other in vitro diagnostic operations supporting clinical trials. Working under the direction of Precision Medicine leadership and in partnership with study teams, Clinical Operations, Biospecimen Leads, testing laboratories and external diagnostic partners, the Scientist owns key operational workstreams, including local test assessment review and approval workflows, local versus central concordance monitoring and data reconciliation, biospecimen planning, and diagnostic partner coordination and tracking. These activities enable timely, accurate patient eligibility testing and support the diagnostic development and regulatory studies behind the portfolio. This role provides the operational continuity needed to expand the capacity of the Precision Medicine organization.

Key Responsibilities –

· Under the direction of Precision Medicine leadership, serves as primary or back-up reviewer for local test assessments supporting clinical trial eligibility, evaluating local laboratory assays (e.g., platform, adherence to the approved assay’s instructions for use, validation status, scoring and cut-off) against protocol and Precision Medicine local test approval requirements.

· Owns operational workflows for local testing, including laboratory onboarding documentation, approval tracking and timely communication of decisions to study teams, Clinical Operations and sites.

· Leads concordance monitoring between local and central test results and performs data reconciliation across clinical, central laboratory and diagnostic partner datasets; identifies and escalates discordance trends and data quality issues with recommended actions.

· Acts as the Precision Medicine point of contact for biospecimen planning on assigned programs, partnering with Biospecimen Leads and Clinical Operations to ensure sample availability, appropriate consent and sample use, and inventory tracking for diagnostic development and regulatory studies.

· Coordinates operational activities with external diagnostic partners and testing laboratories (e.g., validation sample transfers, testing status, data transfers and issue resolution), tracking partner deliverables against program milestones.

· Maintains program trackers and documentation (e.g., testing status, sample inventories, partner timelines).

Qualifications

• Bachelor’s degree or equivalent formal academic qualification in a relevant scientific or technical discipline, such as Biology, Chemistry, or other related scientific fields.
• 2-4 years of experience supporting laboratory operations or a related function; a combination of education, training, and directly related experience may be considered in lieu of formal requirements.
• Minimum of 1-3 years’ experience in biomarker or in vitro diagnostic assay development, validation or clinical testing in a pharmaceutical, diagnostic or clinical laboratory setting.
• Working knowledge of biomarker/in vitro diagnostic platforms (e.g., IHC, NGS, PCR, immunoassay).
• Demonstrated ability to work effectively as a member of a multidisciplinary matrix team and to manage multiple concurrent programs with strong attention to detail.
• Requires comprehensive knowledge of principles, concepts and/or methodologies within drug discovery, development or production.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Working Conditions and Environment: • Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.• Occasional drives to site locations, occasional domestic travel. • Exposure to biological fluids with potential exposure to infectious organisms. • Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions.Physical Requirements:• Ability to work in an upright and /or stationary position for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment. • Occasional mobility needed. • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. …