Overview In this role you will support biomarker and translational strategy for CAR-T programs in Multiple Myeloma, bridging Research and Clinical Development. You will provide insight into CAR-T function and help develop prognostic tools, while collaborating across functions to enable regulatory filings and trial execution. The position offers the chance to influence translational strategies and data-driven decisions at a cutting-edge oncology company.
Responsibilities- Direct PK/PD analysis to support clinical pharmacology for CAR T trials in Multiple Myeloma
- Lead biomarker work on clinical study teams for pivotal/registrational filings
- Review and contribute to clinical protocol design and study activities
- Identify and engage CROs and transfer novel methods
- Collaborate with Clinical Operations, Regulatory, Clinical Data Management and Biometrics/Stats to advance data analyses
- Lead resolution of translational/regulatory queries and support responses
- Prepare data packages for publication and regulatory submissions with medical writers
- Collaborate with Translational Medicine, Bioinformatics and Statistics for exploratory biomarker studies
- Contribute to external discussions, collaborations, publications, and engagements with key opinion leaders
Key requirements- Advanced degree in biology-related field with 3+ years in industry OR Master's with 5+ years OR Bachelor's with 7+ years
- Strong background in cancer immunotherapy/immunology/oncology, with Multiple Myeloma focus
- Experience in regulatory filings
- Understanding of clinical, translational, and mechanistic data
- Familiarity with clinical and biomarker operations
- GxP bioanalytical assay development/validation experience
- Experience with engineered T cells, immunophenotyping, and NGS-based profiling
- Ability to thrive in a matrixed, fast-paced environment with strong collaboration
- Excellent interpersonal and communication skills
- Proficiency in data presentation to cross-functional audiences
- Attention to detail
- strong collaboration
- excellent interpersonal skills
- clear communication
- PK/PD analysis
- biomarker development and correlates
- clinical pharmacology
