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.
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
- 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
#LI-SA1
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.
