Manager - Clinical Biomarker Operations (m/f/d) (40h/week)

About HOOKIPA:
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed programs. In addition, HOOKIPA aims to develop functional cures for HBV and HIV in collaboration with Gilead.

Position Summary:
Reporting to Director of Clinical Biomarker Operations, the candidate should be equipped to work independently in a fast-paced team environment and provide biospecimen operations and clinical trial support for Phase 1/2 studies (including but not limited to development, implementation and overall strategy for clinical biomarker sampling, sample collection, management and biospecimen storage). This individual will work closely with both the Clinical Biomarker and Clinical Operation teams, bridging internal activities with external expertise and/or contract research organizations where appropriate.
The ideal candidate is a team-player who is highly motivated, detail-oriented, can successfully multi-task, understands the broader context and impact of the support that he/she provides, and knows how to identify/recognize issues and proactively propose solutions.

Main Responsibilities:
• Review of clinical protocols, subject informed consent forms, training documents, and other relevant study-related documents to ensure alignment and compliance with sample collection requirements.
• Ensure robust processes for maintaining chain of custody and compliance with GCP/GLP requirements for biospecimen collection.
• Work closely with the Biomarker Scientist to develop specimen collection schedule, processing methods, handling, shipping, and storage that align with the clinical protocol and stakeholder needs.
• Work with Central Labs to design sample collection kits and detailed laboratory manual with guidelines and procedures for sample collection and handling/processing, transport, storage, and shipment to the external vendors
• Responsible for developing training slides and delivering training to internal staff or external partners (e.g., CRO, clinical site staff) as needed.
• Collaborate with data management, CROs and Central labs to develop/oversee effective and efficient processes for biospecimen management including sample tracking and sample header reconciliation, and work closely with internal and external groups/vendors to identify and resolve sample-related issues.
• Responsible for review of vendor invoices against contract and work completed;
identify and transparently communicate inconsistencies. • Identify, communicate and problem solve relevant issues related to samples that present potential risks to study compliance, timelines, or analyses.
• Develop strong working relationships and maintain effective communication with key internal and external stakeholders.
• Collaborate with cross-function study management teams and external vendors to ensure delivery of samples for analyses per project delivery milestones.
• Recommend and implement innovative ideas to increase efficiency and quality of sample- related activities including establishing internal process and systems to support sample management and overall biomarker operations.

Qualifications & Skills:
• Bachelor’s degree with 5+ years of professional experience in a pharmaceutical/biotechnology R&D environment and/or clinical research setting. Experience working at a biotech start-up is a major plus.
• Thorough knowledge of ICH, GCP and GLP guideline along with FDA regulatory requirements
• Demonstrated understanding and first-hand experience working in clinical trial from study start-up through study closure with the ability to contribute through reviews of clinical protocol, ICF and other supporting documents.
• Demonstrated understanding of basic principles of clinical research and clinical procedures involving collection of various types of samples collection, and their handling, processing, and shipment.
• Prior Central Lab and third-party vendor management experience.
• Experience with sample management databases.
• Prior laboratory experience in sample processing, handling, and tracking.
• Basic knowledge of relevant therapeutic and technical areas as well as understanding of the drug development process.
• Professional interpersonal skills, team-oriented approach, collaborative with ability to provide leadership and guidance to a growing team/function.
• Must be comfortable presenting in front of internal and external audiences.
• Ability and knowledge to work effectively with multiple stakeholders (clinical, biomarker research, project management, clinical operations, etc.)
• Leadership skills in conflict management, facilitation, and negotiation.
• Excellent written and verbal communication skills with ability to be diplomatic and professional in all situations.
• Strong project management and organizational skills; must be able to prioritize and work effectively in a fast-paced environment with conflicting deadlines.
• Working knowledge of MS Office and Adobe Acrobat.

What we offer:
• Strong team with dedicated and passionate employees
• State of the art infrastructure
• An excellent working atmosphere
• Opportunities for personal development
• Working in a multinational and multicultural environment

We offer a comprehensive package with competitive salary in the range of USD 100-160k,in addition to paid holidays and sick leave, along with a full range of medical, dental/vision insurance and 401(K) plan. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.
Starting date: as soon as possible

Contact:
If you (m/f/d) are interested in this challenging position, please send your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials to: talent@hookipapharma.com
For more information on HOOKIPA please visit www.hookipapharma.com