We are on the lookout for a skilled Translational and Clinical Biomarker Scientist to join our dynamic team. This pivotal role will focus on enhancing our capabilities in preclinical and clinical biomarker discovery and development across multiple therapeutic areas.
Key Responsibilities:
- Lead and manage biomarker discovery and development strategies, collaborating with external CROs.
- Conduct in vitro, in vivo, and ex vivo studies to propel our drug discovery pipeline.
- Work independently and collaboratively within a cross-functional, matrixed team to uncover the mechanisms of action for our innovative drug candidates.
- Author and review reports and regulatory documents, ensuring compliance and clarity.
- Develop clinical biomarker strategies that highlight the pharmacodynamics, efficacy, and safety of our therapies, supporting informed patient and indication selection.
This role offers a unique opportunity to serve as the Translational Sciences lead, influencing projects from discovery to development while contributing critical insights into biological, disease areas, and clinical challenges.
Qualifications:
- Experience: Minimum of 5 years in the biotechnology or pharmaceutical industries, focusing on therapeutic development using complex in vitro and in vivo disease models.
- Hands-On Skills: Proficiency in executing studies, writing protocols, and collaborating with CROs, while also being comfortable in the lab.
- Clinical Biomarker Expertise: Knowledge in pharmacodynamic, predictive, and safety biomarker development to support clinical translation and patient selection.
- Regulatory Proficiency: Experience authoring clinical protocols, IND filings, CSRs, and NDAs.
- Experimental Background: Direct experience with pharmacology models, PK/PD, efficacy, and cell/tissue-based biomarker discovery.
- Data Analysis: Expertise in analyzing and interpreting multi-omics datasets (e.g., bulk or scRNAseq) to inform biomarker discovery and therapeutic mechanisms of action.
- Project Leadership: Experience leading project teams, analyzing complex data, and presenting findings to drive strategic decisions.
- Therapeutic Area Knowledge: Familiarity with therapeutic programs in Immunology, Inflammation, Endocrinology, or Metabolic Disease.
- Bioinformatics Skills: Experience in establishing workflows and utilizing platforms like Jupyter Notebook for data analysis and visualization is a plus.
- Mentorship and Management: Proven track record in mentoring scientists, leading cross-functional teams, and managing external collaborations effectively.
