Scientist, Pharmacodynamic Biomarker Development

Position: Contract Scientist, Pharmacodynamic Biomarker Development

Contract Scientist, Pharmacodynamic Biomarker Development

Watertown, MA
· Contract

Rapidly growing biotech is seeking an experienced contract scientist to join our Immunology Research & Translational Early Development team in Watertown, MA. This role sits at the heart of our clinical development program for our lead program,a novel immunosuppressant. The ideal candidate will be laboratory based and have expertise in the development, qualification, and outsourcing of clinical pharmacodynamic biomarker assays that will be central to our clinical program, with potential to extend this work into several animal models.

This is an opportunity to make a direct and meaningful contribution to a program that could transform the standard of care for transplant patients.

Key Responsibilities:

• Develop and optimize pharmacodynamic biomarker assays to support the Phase 1 clinical and preclinical program, with a primary focus on human whole blood assays and T cell assays.
• Conduct fit-for-purpose clinical biomarker assay qualification and validation aligned with CTA/IND submission needs and timelines.
• Adapt and transfer assays for potential use in nonhuman primate samples, working with internal and external stakeholders to ensure cross-species translatability of key readouts.
• Generate high-quality, well-documented data and present results clearly and regularly to the internal project team.
• Work closely with the Immunology Research and Translational early development team and external CROs and clinical site partners to support bioanalytical method transfer, implementation, and troubleshooting.
• Contribute to the broader PK/PD biomarker strategy foras the program advances toward and through first-in-human studies.
• Graph and interpret clinical biomarker data from the LIFE-001 clinical and preclinical program as needed.

What you will need to be successful:

• M.S. or Ph.D. in immunology, pharmacology, cell biology, or a related field, with hands-on laboratory experience in an academic, biotechnology, or pharmaceutical setting.
• Demonstrated expertise in flow cytometry and/or molecular (RNAseq, RT-PCR) assay development, including panel design, assay optimization, and data analysis using software packages such as Flow Jo.
• Extensive experience working with primary human immune cells, including whole blood, PBMCs, and enriched T cell populations, across stimulation and co-culture protocols.
• Strong working knowledge of T cell activation biology, and its pharmacological modulation — experience with calcineurin inhibitors or related immunosuppressant programs is a meaningful advantage.
• High proficiency with immunological platforms including ELISA, MSD, Luminex, and intracellular signaling assays.
• Experience with clinical biomarker assay qualification and validation in a regulatory setting (CTA/IND-enabling) is strongly preferred.
• Experience with whole blood assays and transcription factor assays a plus.
• Excellent assay troubleshooting skills.
• Prior experience assessing pharmacodynamics with in vivo pharmacology studies a plus.
• Highly organized and detail-oriented, with a strong track record of generating accurate, reproducible data and maintaining thorough laboratory records.
• Comfortable working both independently and as part of a cross-functional team, with the ability to communicate technical challenges and results clearly to a mixed scientific audience.
• Ability to travel to partner sites or CROs on occasion to ensure assay transfer and data quality

What We Offer

• Competitive contract compensation (salary, benefits and equity).
• The opportunity to work on a differentiated best-in-class clinical stage program at a critical inflection point in its development.
• A collaborative, science-driven culture where individual contributions are visible and valued.
• Direct engagement with an experienced team committed to rigorous clinical and translational science.

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