Senior Manager Biosamples

Contract Length: 10+ months renewableLocation: Onsite in the Bay area is preferred (hybrid schedule of 3 days onsite, 2 days remote); full remote work can be considered for non-local candidates, with full accommodation of Pacific working hours and willingness to travel onsite for company events if neededOverviewThe Biosample Senior Manager will manage the full biospecimen lifecycle for our client’s clinical programs through collaboration with Clinical Operations, Data Management, Clinical Outsourcing, Translational Medicine, Pharmacology scientists, and external vendors that support their clinical studies. This is an independent contributor role that will be responsible for managing the program, with willingness to dive into the weeds as needed. This individual will drive cross functional strategic alignment and ensure effective biospecimen molecular collection. This role will be reporting into Biomarker operations leadership.Key Accountabilities/Core Job Responsibilities:Function as Program Lead for the full lifecycle of their assigned molecule from protocol through database lock from both a high-level and hands-on perspectiveOrganize cross functional groups to ensure all internal and external stakeholders are in strategic alignment for study operationsDevelopment of biospecimen lifecycle strategies through close collaboration with project teams and scientists (for PK, ADA, PD/Biomarkers, and Safety)Management of external lab vendors, ensure program level consistency and cross-program standardization of biospecimen collection, processing, storage, and analysisContribute to development of study protocols, ICFs and other relevant study documentsManage the creation of complex sample management plans and laboratory documents that ensure the proper collection and storage of samples at clinical sites and external vendorsCollaborate with Clinical Operations, Outsourcing, and Quality Assurance in the selection and oversight of central laboratories and specialty bioanalysis labs to ensure they meet study requirements and adhere to relevant compliance standardsCreate systems and tools to manage sample analysis plans and enable study leads to deliver samples to appropriate analysis vendors on timeFacilitate external analysis vendor interactions with Data Management to ensure consistency in the transmission of sample metadata for accurate identification of analyzed samplesLead process improvement projects and participate in cross-functional projects and working groups Qualifications/Skills: Bachelor’s degree in Biochemistry, Chemistry, Biology, Immunology, Neuroscience, Medical Technology, or related field is recommended7+ years of experience or more with a pharmaceutical/CRO company as a program lead, managing clinical trial phases I-III; Medical Device experience will not be a fitClinical trial management experience at Health Institutions may also be consideredExperience with and specific knowledge of biosample management for clinical trialsExperience with management of external laboratory vendorsAny experience qualifying potential vendors is a plusAbility to lead effectively in a cross-functional team matrix environmentThere may be some mentorship involved, but there will not be direct people management or direct reports willFamiliarity with relevant FDA & ICH/GCP regulationsAbility to develop, review, and interpret clinical research protocolsTechnical know-how to create tools to solve operational challenges and improve workflowsPrevious experience in people management is a plusOther requirements:Entrepreneurial spirit with “can do” attitude and commitment to work as part of a teamSeeks change & values innovationAdvanced planning and organization skills and excellent analytical skills