Precision Medicine Operations Lead – SKDL Programming Lead

• Participate in cross-functional study team meetings and workstreams supporting precision medicine strategy
• Support clinical study teams as subject-matter expert for sample management and testing
• Anticipate challenges, manage project risks, and respond to internal and external stakeholder queries
• Develop and review sample-related sections of study documents, including clinical protocols, ICFs, and sample management guidelines
• Support creation and validation of specialty laboratory databases for data collection and sample kit tracking
• Manage biosample process planning and execution, including storage, shipping, and data transfer
• Oversee acquisition and testing of clinical trial samples for biomarker research
• Assess biosample vendors, review proposals and bids, and define contractual scope
• Forecast operational costs and timelines; manage budgeting, invoicing, and reporting
• Determine how biomarker data is captured, blinded, transferred, and reported
• Develop and review data transfer specifications and related documents
• Guide and train clinical teams and investigative sites on biospecimen collection, storage, and shipment
• Ensure human sample transfers are documented, tracked, used, and destroyed according to SOPs and regulations
• Manage clinical trial supplies, logistics, samples, kits, data operations, vendor management, and related processes when assigned
• Oversee kit inventories, sample collection and tracking, data query resolution, regulatory submissions, import/export documentation, proforma invoices, LIMS, and functional metrics
• Create, implement, monitor, and improve clinical study logistics strategies
• Develop tools and dashboards for biomarker samples, kits, logistics, and laboratory data when acting as programming lead
• Aggregate, extract, process, and assess confidential data using technical tools, systems, and programming languages
• Assess laboratory databases, resolve biomarker data queries, and support database lock activities
• Complete required training, timesheets, expense reports, and CV updates
• Maintain effective relationships across platform, business, research, and enabling lines

• Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry
• Working knowledge of clinical drug development process and clinical databases
• Working knowledge of ICH and GCP guidelines
• Working knowledge of US FDA and/or local country regulations as applicable
• Bachelor's degree in life sciences or equivalent (science, technology, engineering, or mathematics) or relevant work experience
• Biology or equivalent major preferred
• Fluent in speaking/writing English
• Strong project management and organization skills in a matrix environment
• Analytical and problem-solving experience
• Excellent written and verbal communication skills
• Effective communication and interpersonal skills, with proven ability to build relationships internally and externally
• Proficiency in Microsoft Office applications, including strong Excel knowledge
• Proficiency in relevant role-specific systems
• Proficiency in Python, R, Perl, SQL or other programming languages, plus familiarity with APIs and Linux/Unix environments, if acting as programming lead
• Travel not expected but may occur periodically

• Home-based work from a home office
• Time for outside life
• Annual performance-based bonus plan eligibility for eligible roles
• Annual salary review
• Total rewards incentives for eligible roles