Director - Clinical Biomarker Technical Lead
|Date posted:||01. August 2022|
The position is within the Clinical and translational biomarkers. The Biomarker Clinical Technical lead will play a critical role in supporting clinical biomarker assay development from early phase to late stage of drug development including oversight and management of external and internal partners for timely delivery of high quality and regulatory compliant biomarker analytical assays and data. The role requires an individual who can provide technical expertise for identification and selection of high-quality clinical biomarker vendors in conjunction with cross-functional study team members, oversight of clinical biomarker deliverables, assay validation, delivery of samples, analysis and preparing reports (SME).
- Leads and oversees fit-for-purpose biomarker assay development and method design, validation, data quality review, corresponding sample analyses & reporting to meet evolving program objectives and regulatory expectations. Guides and leads external study teams with respect to the selection and execution of the analytical strategy, including development of novel technical capabilities with vendors.
- Evaluates complex data (i.e., evaluates aberrant results and data trends), anticipates and corrects potential issues, and is able to appropriately guide study teams through complex issue resolution
- Functions as key point of contact of external & internal laboratories and leads selection, qualification, performance evaluation, periodic visits and audits of CRO laboratories conducting clinical biomarker assays.
- Supports the clinical trial conduct within the scope of the Clinical biomarker Group responsibilities, including development and review of documents, assay validation plans, defining scope of work for CROs, sample management, bioanalytical study planning & reporting, ensured compliance with clinical SOPs & policies
- A strong preference for a candidate with broad technical knowledge and experience analyzing complex data such as genomic and transcriptomic data analysis pipelines in R or python and interpretation
- PhD (5+ years) or MS (7+years) in immunology, molecular biology, cancer biology or related biological sciences field with equivalent experience in the pharmaceutical or biotech industry of proven
- Robust Knowledge and experience in biomarker assays; method development, assay validation and implementation within clinical trials, in a broad range of molecular, immunological technologies (e.g., FACS, MSD, NGS, PCR, ISH etc) and associated data analysis methods as well as other cell based and circulating biomarker technologies
- Oversee data generation and analyze biomarker data (e.g., large-scale omics datasets including RNASeq, Exome Sequencing, NanoString, FACS, MSD and other related data) from clinical trials and real-world database and derive clinically meaningful interpretations
- Solid knowledge in Immunology, immunogenetics and large-scale data analysis generated by one or more high-throughput molecular assays: next-generation sequencing, flow cytometry, mass spectrometry proteomics, etc.
- Experience in use of a high-level programming language, such as R or Python, for complex data analysis and reproducible research practices is a plus
- Oversee data generation and analyze biomarker data (e.g., large-scale omics datasets)
- Ability to work independently as well as collaboratively in a matrixed team environment.
- Strong oral/written and interpersonal skills required and organizational and networking 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, Sodexo pass
- 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
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: firstname.lastname@example.org
For more information on HOOKIPA please visit www.hookipapharma.com