Specimen and Sample ManagerApply
Icosavax, Inc. (NASDAQ: ICVX) is a publicly traded biopharmaceutical company leveraging its innovative Virus Like Particle (VLP)-based platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases. Icosavax’s VLP platform technology is designed to enable multivalent, particle-based display of complex viral antigens, which it believes will induce broad, robust, and durable protection against the specific viruses targeted. Icosavax’s pipeline includes vaccine candidates targeting respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Based in Seattle, Icosavax was formed in 2017 to advance the breakthrough VLP technology from the Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases.
ICVX is moving towards advanced development (Ph2 trials) of its lead bivalent RSV/ candidate vaccine in global trials. ICVX is looking for a Specimens and Sample Manager to provide oversight of sample kits, specimen inventory, specimen shipments: import and export permitting, and laboratory data reconciliation to support its expanding clinical trials.
The Specimen and Sample Manager will support the VP, Clinical Operations to support ICVX’s clinical studies in diverse operational tasks.
Reviews and provides input into clinical study protocols, informed consents and central laboratory documents to ensure quality and accurate and precise operationalization of specimen and sample strategies.
Supports contracting process by soliciting and reviewing Scope of Work from bioanalytical and clinical laboratory testing vendors; works with Contract Specialist, Business Operations, and Procurement to ensure timely execution of SOWs.
Monitors bioanalytical and clinical laboratory testing vendors to ensure timely clinical sample receipt, sample testing and data transfers to meet downstream data analysis timelines.
Responsible for developing Clinical Sample Management Plan.
Ensures bioanalytical and clinical laboratory specimen handling and processing steps are appropriately described in the Clinical Lab Manuals for collection, processing, and shipping of patient samples. Ensures maximal specimen accrual and quality.
Coordinates and enables operational activities required to manage the lifecycle of bioanalytical and clinical laboratory specimens, including oversight of sample collection at site, shipment to vendor for testing/processing, analysis, reconciliation and final sample disposition.
Resolves queries from various parties (Central Lab, bioanalytical and clinical laboratory testing vendors) related to clinical samples and escalates issues to ensure timely resolutions.
Utilizes sample tracking systems to report progress and identifies issues. Supports Bioanalytical consultant to timely resolve issues.
In close collaboration with Biometrics vendor, support the timely finalization of Data Transfer Guidelines, and transfer of data from testing vendors or clinical CRO to meet clinical trial and translational timelines.
Diligently track bioanalytical operational deliverables using defined template.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
BS or MS in Biochemistry, Biology, Medical Technology, Immunology, Pharmacy or related pharmaceutical sciences.
5+ (BS) or 3+ (MS) years of relevant work experience in drug development, sample/bioanalytical specimen management or clinical trial project management.
Knowledge of clinical trials and understanding of the role of bioanalytical and clinical laboratory assessments in clinical studies.
Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling.
Ability to oversee sample management activities across multiple studies.
Experience with sample management database is strongly desirable.
Demonstrated ability to collaborate with a diverse group of scientists, clinical team members, vendor labs, and stakeholders to support clinical development strategy. Works effectively in a dynamic operational environment with cross functional stakeholders.
Excellent written, organizational and interpersonal communications skills in order to efficiently and succinctly update the stakeholders and internal team members on progress, address questions and issues, as well as interfacing with external vendors.
Strong attention to details, timelines and quality.
Works successfully under pressure with tight timelines.
Eager to grow and develop capabilities.
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
Location: Remote USA
Must be eligible to work in the USA
To reduce the presence and severity of COVID-19 cases in the workplace and in our communities, Icosavax requires all newly hired employees to be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state and local law.
The salary range for this position is $120,000 – 140,000 per year; the base salary will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered health insurance (medical, dental, vision), health savings account with company contribution, flexible spending account, life insurance, short- and long-term disability, employee stock purchase plan, 401(K) plan with company contribution, vacation, sick and safe time, company holidays and floating holidays.