Clinical Biomarker Scientist
Theravance Biopharma’s Clinical and Translational Pharmacology group is responsible for ensuring outstanding conduct of translational medicine experiments including furthering our understanding of disease biology and identification of patient populations who may be more likely to derive benefit from drugs in our development portfolio.
We are seeking a dynamic Translational Scientist to lead teams responsible for delivery and execution of high quality biomarker strategies for evidence of target engagement, pharmacodynamic and patient selection endpoints for small molecule projects entering early clinical Development and beyond. The position is in based in South San Francisco, CA.
- As Translational Scientist for early and late stage projects, responsible for working closely with project team leaders, clinical study directors and other functions of the project team to implement clinical biomarkers into clinical trials and provide translational medicine solutions for project needs.
- Responsible for integrating translational research and clinical development, developing a biomarker strategy in alignment with clinical development objectives, leading efforts for data generation, interpretation and communication to the development teams.
- Effectively engages with teams and utilizes internal and/or external advisory bodies to define, revise and progress translational/biomarker plans.
- Engages team members to ensure alignment of biomarker strategies with clinical operational plans with functional area capabilities
- Responsible for understanding internal and external research environment, partnering with discovery biology and other functions to coordinate the execution of biomarker strategies including obtaining appropriate resources to deliver on goals
- Identify and maintain close relationship with CROs in outsourcing biomarker analysis of clinical trial samples. Work closely with Trial Operation in setting up logistics, tracking sample, performing data analysis and data transfer for statistical analyses.
- Responsible for authoring biomarker sections of clinical trial related documents including IB, IND, CSR, as well as regulatory submission.
- Ensures appropriate decisions are made in a timely manner at the appropriate levels to drive biomarker deliverables.
- Communicates key biomarker program information, risks, and milestones, and manages information flow across team members and senior management.
- Continually analyzes progress, engages in critical thinking, and asserts strong problem-solving towards delivering key data and interpretation essential for decision making.
- MD, PhD, or equivalent advanced degree in biology, molecular biology, pharmacology or related field
- Experienced scientist with 10+ years of experience in the drug development process, with focus on clinical biomarkers
- Strong background in translational medicine, applying PK/PD/efficacy relationships, drug MoA, and systems pharmacology to enable robust decision making in clinical development
- Strong preference for candidate with experience in inflammatory disease biology and immunology
- Significant understanding of all functional areas of drug development, including, biology, toxicology, clinical development, diagnostic development, etc.
- Demonstrated ability to work and lead in a cross-functional team environment
- Ability to multitask across multiple development assets.
- Excellent written and verbal communication skills.
- Ability to identify / follow cutting edge research to develop innovative approaches.
- Proven ability to frame issues, ask the right clarifying questions, and rationalize decisions.