Scientist, Translational Medicine
About The Position
The Scientist, Translational Medicine focuses on scientific and operational delivery of translational biomarker and target-engagement activities across assigned therapeutic-area programs, with an emphasis on biological mass spectrometry and quantitative bioanalysis. The role supports execution through selection of fit-for-purpose analytical approaches, vendor coordination, method development and qualification, integration into preclinical and clinical studies, and sample testing at CROs. It works closely with Research, Translational Medicine, Clinical Development, Clinical Operations, and external partners. The position supports translational biomarker and target-engagement activities for first-in-human and early-phase studies and related preclinical work, aligned with Translational Medicine strategies. It applies quantitative LC-MS approaches to proteins, peptides, endogenous small molecules, and other biomarkers as appropriate to program needs. The scientist coordinates vendor operations, tracks deliverables and budgets, supports integration of biomarker plans into studies, monitors assay and vendor performance, and helps plan and execute clinical specimen collection, testing, and data delivery. The role also maintains documentation for GxP compliance and communicates scientific findings, analytical limitations, and recommendations to multidisciplinary teams.
Requirements
- BS/BAMS in Biology, Chemistry, or a related scientific field and 2+ years of relevant industry experience; or MS/MS in Biology, Chemistry, or a related scientific field and some relevant industry experience; or PhD in Biology, Chemistry, or a related scientific field and some relevant industry experience.
- Operational rigor and attention to detail.
- Consistent ability to meet multiple deadlines with a high degree of accuracy and efficiency.
- Strong execution mindset and ability to anticipate and manage risks.
- Collaborative, team-oriented approach.
- Ability to translate scientific and operational requirements into actionable plans.
- Ability to manage multiple priorities and collaborate effectively across functions.
- Strong written and verbal communication skills.
- Experience supporting first-in-human or early-phase clinical studies.
- Experience working with CROs and external laboratories supporting clinical studies.
- Strong organizational and project management skills.
- Familiarity with clinical biomarker workflows and early clinical development.
- Working knowledge of GxP requirements and biomarker or bioanalytical operations.
- Experience working with CROs to support clinical assay development and sample testing.
Nice To Haves
- Experience with Smartsheet.
Responsibilities
- Support translational biomarker and target-engagement activities for first-in-human and early-phase studies, and related preclinical work, in alignment with Translational Medicine strategies.
- Apply quantitative LC-MS approaches to proteins, peptides, endogenous small molecules, and other biomarkers as appropriate to program needs.
- Coordinate day-to-day activities with CROs and external vendors, including assay laboratories; support assay feasibility, fit-for-purpose method development and qualification, troubleshooting, and sample analysis.
- Track vendor contracts, scopes of work, budgets, and timelines in collaboration with internal stakeholders.
- Use Smartsheet, Excel, and other project management tools to track operational deliverables, risks, and dependencies.
- Support integration of biomarker and assay plans into preclinical and clinical protocols and study execution plans.
- Monitor vendor and analytical method performance, evaluating data quality, assay sensitivity, selectivity, precision, reproducibility, and issues affecting timelines or interpretation.
- Collaborate with Research, Translational Medicine, Clinical Development, Bioanalytics, DMPK, Pharmacology, Data Science, Clinical Operations, Outsourcing, Regulatory, Quality Assurance, Data Management, and other stakeholders to support strategy and execution.
- Drive planning, implementation, and execution of clinical specimen collection, testing, and data delivery activities with cross-functional teams.
- Maintain accurate documentation to support GxP compliance and ensure activities follow GxP requirements, internal SOPs, and applicable regulatory guidance.
- Connect emerging biological findings with quantitative measurements that can be evaluated in preclinical and clinical studies.
- Provide regular project updates and communicate scientific findings, analytical limitations, and recommendations to multidisciplinary teams.
- Perform other duties as assigned.
Benefits
- Annual bonus with a target of 20% of earned base salary.
- Eligibility to participate in an equity-based long-term incentive program.
- Retirement savings plan with company match.
- Paid vacation, holiday, and personal days.
- Paid caregiver, parental, and medical leave.
- Medical, prescription drug, dental, and vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
