HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells to address unmet needs in cancer.
This leveraging its proprietary, versatile platform to engineer a broad pipeline of differentiated arenaviral therapeutics. These novel immunotherapies induce robust antigen-specific killer T cells to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. HOOKIPA’s platform technology uses replicating viral vectors based on the target cancer, with the potential to induce killer T cell response levels previously not achieved by other immunotherapy approaches.
HOOKIPA’s pipeline includes wholly-owned investigational arenaviral immunotherapeutics targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed projects. In addition, the company aims to develop functional cures of HBV and HIV in collaboration with Gilead.
The Clinical Biomarker team at Hookipa Pharma Inc. is seeking a talented and motivated individual with experience in immunology, oncology, and translational medicine to join the biomarker team to help advancing HOOKIPAs immune-oncology and infectious disease assets in early clinical development. In this role, the individual will connect science and operations to implement and then manage biomarker research in multiple Phase 1-3 clinical trials. This role will employ operational and logistical strategies ensuring clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. The Clinical Biomarker Operation lead achieves these objectives via scientific expertise, strategic thinking, a global mindset, and cross-functional collaboration.
- Drives the implementation and execution of the clinical biomarker strategy for clinical programs in early and late stage
- Oversee and coordinate operational aspects such technical validation of assays both internally and at external CROs, review of SOWs, and data management for one or more clinical programs and keep an overview on all open and upcoming items.
- Align with Project team members to ensure that biomarker timelines, budget and resources are meeting overall program requirements.
- Responsible for CROs and vendor management
- Understand the biomarker strategy, develop, optimize, transfer, and validate assay with the in-house or CRO central analytical lab team and implement clinical biomarker analysis in appropriate clinically validated assay/methodologies
- Develop assay specific data transfer specifications by gathering input from translational science leads, data management, and data scientists to ensure efficient transfer of clinical assays to CROs.
- Drive identification of risks or bottlenecks and lead the design of mitigation strategies.
- Drive cross-functional communication and implement a steady information flow. In case of conflicts, align with project members, and assess the impact on clinical and regulatory areas as well as project timeline and costs.
- Oversee sample analysis and data transfer; ensure that the data are transferred to correct databases.
- Review, clinical biomarker plan in alignment with the project leads (for example, laboratory manuals, informed consents, analytical plans, and SOWs)
- Continuously evaluate newer, innovative technology platforms and applicability to clinical biomarker testing.
- Support writing and reviewing of documents for INDs / regulatory section submissions.
Qualifications & Skills:
- PhD, PharmD and/or MS with >5 years’ experience in the pharmaceutical industry or equivalent; substantial understanding of clinical development and translational biomarkers are required
- Strong scientific background and knowledge in immunology, cancer biology or related field and vendor management
- Strong knowledge in Immunological assays, flow cytometry and T cell analysis, and interpretation of biomarker data
- Familiarity with Immunoassays, MSD, nucleic-acid RT-qPCR, next-generation sequencing, handling data generation and analysis of large-scale Omics biomarker data analysis and derive clinically meaningful interpretations
- Ability to work both independently and collaboratively, and to handle several concurrent, fast-paced projects while conforming with rigorous requirements of clinical studies.
- Strong track record of successfully managing complex projects
- Excellent communication, data presentation, and visualization skills, ability to adjust priorities in a fast-paced environment.
- Vendor management, and successfully manage complex projects
- Excellent communication, data presentation, and visualization skills, ability to adjust priorities in a fast-paced environment
What we offer:
- Strong team with dedicated and passionate employees
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities for personal development
- Employee benefits such as health screening, public transportation card,
- Working in a multinational and multicultural environment
We offer a comprehensive package with competitive salary, 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