About the Role:Focuses on operational delivery of assigned Therapeutic Area (TA) activities, including vendor coordination, contract and budget tracking, and use of project management tools to ensure high-quality, on-time data delivery. Will support execution through vendor selection, fit-for-purpose method development and validation, integration into clinical protocols, and sample testing at CROs, working closely with Translational Medicine, Clinical Operations, and external partners.
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Your Contributions (include, but are not limited to):- Support clinical Therapeutic Area operations for First In Human (FIH) and early-phase studies in alignment with Translational Medicine strategies
- Coordinate day-to-day activities with CROs and external vendors, including assay laboratories, and support fit-for-purpose development and validation of clinical assays
- 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 operational plans into clinical protocols and study execution plans
- Monitor vendor performance and escalate risks or issues impacting timelines, quality, or budget
- Collaborate cross-functionally with Translational Medicine, Outsourcing, Clinical Operations, 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
- Support inspection readiness by maintaining accurate documentation related to vendors, contracts, and execution
- Provide regular status updates and support additional operational activities as needed
- 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
- 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
- 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
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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.
