Principal Translational Scientist

About the Role:

The Principal Translational Scientist will work in a multidisciplinary oncology project team to develop novel cancer therapies.  As a Principal Translational Scientist, you will drive and contribute to the clinical develop of new programs by building and executing the translational research and biomarker strategy.  In addition, the role will be responsible for developing and implementing precision medicine, biomarkers, cellular, imaging, flow cytometry and immunohistochemical based assays designed to assist and guide evaluation of drug pharmacology mechanisms of action, and potential correlates of response and /or toxicity to our novel drug candidates in clinical studies.

Responsibilities Include:

• Participate in the development of translational strategies, in collaboration with other functional experts, for the discovery, development and implementation of biomarkers in clinical trials to support indication selection, demonstrate pharmacologic/pharmacodynamic effects, characterize dose-response relationships, investigate mechanisms of action, and evaluate patient or disease factors that correlate with therapeutic response.
• Contribute to the preparation of regulatory documentation and interactions, including preparation of Translational/Biomarker sections in Clinical protocols, Investigator Brochures, Compound Development Plans, and Clinical Study Reports.
• Establish and maintain collaborative relationships with internal and external functional experts that can contribute to the TR strategy. Responsible for managing scientific content and execution of research agreements with external collaborators.
• Lead internal and outsourced development and qualification or validation of biomarker assays for clinical trials, applying experience across multiple methods (e.g., flow cytometry, immunohistochemistry, soluble biomarker assays, PCR) to develop robust assays, generate and analyze data and provide expert interpretation of the effects of promising drug candidates on the immune system and disease biology.
• Establish and manage relationships with external assay development companies and CROs to drive execution to established program deadlines
• Author relevant sections of regulatory documents (e.g., INDs, briefing documents, clinical protocols, clinical study reports).
• Communicate data and strategies effectively to internal project teams, senior management, and external partners/organization.
• Perform other duties and responsibilities as assigned.

About You: Required Education, Skills, and Experience

• Medical Doctoral Degree (PhD/MD/DVM/etc.) in Immunology, Virology, Oncology, Cell Biology, or a related field.
• 12 years of relevant experience with 5 years of translational research, applicable biomarker, and/or drug discovery or clinical trial experience.
• Strong analytical skills and experience working with bioinformaticians to analyze large omics‐ type datasets.
• A strong publication record demonstrating relevant experience in early drug development, translational research, biomarkers or clinical trials.
• Track record of development of strong working relationships with external vendors.
• Understanding of data quality verification, warehousing and transfer to formats compatible with Springworks internal data handling systems
• Experience with development, qualification, validation, and execution of biomarkers assays (such as soluble markers, flow cytometry, IHC, PCR, genomic profiling) with 3rd party vendors and contract laboratories.
• Understanding of clinical operations and translational activities supporting clinical trials, including participation in clinical protocol, ICF, IND and/or BLA writing.
• A strong team player with ability to collaborate in cross functional teams and working closely with clinical operations, regulatory, bioinformatics, clinical pharmacology, toxicology and research colleagues, and a passion for science and helping discover and develop novel therapies for unmet medical needs.
• Able to work cooperatively and independently in a fast-paced, matrixed environment.
• Ability to champion a science led approach to drug development process in a timely manner to achieve cross functionally aligned program objectives.
• Demonstrates ability to translate & present complex information to others effectively.
• Ability to influence without direct authority.
• A detail-oriented, pro-active, enthusiastic, and goal-oriented personality
• Ability to travel occasionally (>10%)

Preferred Education, Skills, and Experience

• Experience applying molecular, cellular, and imaging technologies in clinical trials to demonstrate drug pharmacology and inform patient selection strategies; expertise in HBV molecular assays and flow cytometry.