About the Role:Focuses on scientific and operational delivery of translational biomarker and target-engagement activities across assigned Therapeutic Area (TA) programs, with emphasis on biological mass spectrometry and quantitative bioanalysis. Will support 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, working closely with Research, Translational Medicine, Clinical Development, Clinical Operations, and external partners.
Your Contributions (include, but are not limited to):- Support translational biomarker and target-engagement activities for First In Human (FIH) 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, and 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
- Utilize 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, critically evaluating data quality, assay sensitivity, selectivity, precision, reproducibility, and issues impacting timelines or interpretation
- Collaborate cross-functionally 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 in close collaboration with cross-functional teams
- Maintain accurate documentation to support GxP compliance, ensuring activities are conducted in accordance with GxP requirements, internal SOPs, and applicable regulatory guidance
- Work across Research and Translational Medicine to 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
- Other duties as assigned
Requirements:- BS/BAMS in Biology, Chemistry, or related scientific field AND 2+ years of relevant industry experience OR
- MSMS in Biology, Chemistry, or related scientific field AND some relevant industry experience OR
- PhD in Biology, Chemistry, or 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 with 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; experience with Smartsheet preferred
- 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
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The annual base salary we reasonably expect to pay is $89,800.00-$123,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
