Senior Manager, Clinical Biomarker Operations

About us:Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated therapies at a fast pace. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.Position overview:The Senior Manager, Clinical Biomarker Operations plans, implements, manages, and drives biological sample logistics within Ventus clinical trials, working within our Clinical Operations function, under the leadership of the Head of Clinical Operations (or designee) and in collaboration with the Clinical Operations and cross-functional development team.Responsibilities:Advise on and deliver the biosample strategy within clinical program(s) in accordance with the requirements of quality, and ethical and regulatory standards, including ICHGCPGLP.Ensure standardization and harmonization of biosample activities across clinical trials and oversight of sample collection, processing, storage, and reconciliation, maximizing biosample accrual and quality.Review clinical study protocols, informed consents, laboratory documents, case report forms, and service provider laboratory scope of work documents for sample handling details.Responsible for ensuring ethical use of biosamples collected in Ventus clinical trials.Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of patient samples (oversight of sample collection at site, shipment to vendor for testingprocessing, analysis, final sample disposition, transfer to long term storage and oversight of sample inventory, quality and service provider)Ensures project level consistency occurs for biosampling across studies and is the primary point of contact for project, clinical, and study teams, contributing to innovation and improvement activities in collection, processing and data delivery.Track and report on biosample management statusprogress, address issues, and resolutions.Collaborate with internal and external team membersLead, plan, and chair service provider meetings as neededRequirements:Bachelor's degree, preferably in a relevant scientific or healthcare discipline, or equivalent experienceMinimum of 5 years of hands-on experience in clinical biosample project management requiredExperience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions, EU and Asia filing experience a plus.Must understand the drug development process to effectively manage internal and external cross-functional teams.Proven ability to build strong relationships with external partners, CROs, and biosample vendorsKnowledge of regulations and requirements for clinical trial authorization and tissue storage and transfer in major countries.Project management skills with ability to identify risks and issues, and propose appropriate measures as requiredExcellent team management abilities with a comfort level working with senior management, and ability to influence without authorityEstablish and nurture highly effective relationships with colleagues and key stakeholders, of diverse backgrounds and expertise, that support and advance company goals and objectivesDemonstrated ability to solve problems with innovative solutions along with strong organizational skillsSolid oral and written communication skills requiredAbility to thrive independently and collaboratively in a fast-paced, entrepreneurial environment, and the flexibility to adapt to changing program needsFlexibility to travel domestically and internationally as requiredProficiency with Microsoft Office

Created: 2025-01-27