Director/Senior Director, Non-Clinical Pharmacology Lead

Director/Senior Director, Non-Clinical Pharmacology Lead - San Diego, California 

We’re a different kind of biotech company.  And we’re here to make a difference. 

Prometheus Biosciences, Inc. (Nasdaq: RXDX), is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases.   

The Company’s precision medicine platform, Prometheus360™, combines proprietary machine learning-based analytical approaches with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.   Prometheus Biosciences was named Best Places to Work by Biospace in 2022 and is headquartered in San Diego, CA.  

Summary  

The Director or Senior Director of non-clinical in vitro and in vivo pharmacology will be responsible for development, management, and maintenance of strategy and execution of non-clinical pharmacology.   

Work closely with project leads to identify, establish and implement pharmacology assays and studies including PK, target occupancy, PD readouts, PK/PD relationships.  

Manage relationships with consultants and vendors for all non-clinical activities, including pharmacokinetics across all development programs and projects.  Contribute to design and execution of toxicology, TK studies by partnering internally, with CROs and consultants.  

Work with core project team members, vendors and consultants, as indicated, on the non-clinical study designs and protocols, and oversee the conduct, interpretation of results, and reporting of non-clinical studies. 

Represent the Non-clinical function on the core and project teams as applicable. 

Contribute to the authoring and review of non-clinical documents for Investigator’s brochures and all regulatory submission documents in collaboration with the core project team members and vendors.  

Responsibilities  

• Responsible and accountable for non-clinical studies across all development programs and projects, including vendor management  
• Partner with project leads to enable non-clinical studies 
• Contribute to all non-clinical aspects for Investigator brochures and regulatory documents 
• Contribute to budget planning and oversight for non-clinical activities in collaboration with Program and Project Management    
• Contribute to internal process improvement activities, which could include authoring or co-authoring controlled documents (e.g., SOPs) and guidance documents, as needed 

Education and Experience 

• PhD (Pharmacology/Immunology) or DVM with at least an undergraduate degree in toxicology and or pharmacology 
• 10 or more years of experience in pharmaceutical development with focus on non-clinical, pharmacology, ADME, PK-PD and toxicology studies 
• Expertise in Pharmacology/Physiology, preclinical/clinical Pharmacology and IND-enabling studies 
• Hands on experience with basic NCA analysis of PK data
• Hands on experience with mathematical modeling of PK, exposure, target occupancy data to predict FIH, or experience with managing interactions with CROs regarding these areas is desirable 
• Extensive experience in biologics drug development preferred 
• Experience in IND enabling and submission activities in the pharmaceutical industry; experience in early development projects including FIH and FIP dose selection 
• Comprehensive knowledge of animal and human biology and physiology 
• Broad understanding of drug discovery and development and the regulatory approval process with a focus on biologics drug development 
• Ability to integrate complex scientific ideas, generate testable hypotheses and execute 
• Experience in due diligence to support BD activities 
• Proven scientific/leadership expertise (working in teams, managing people/projects commensurate with level) 
• Provides and accepts input on study design and data interpretation and fosters a spirit of teamwork 

Essential Skills and Abilities 

• Leadership capabilities for matrixed, cross functional teams 
• Ability to work on several projects and assignments at the same time, with appropriate prioritization 
• Ability to independently design, plan, and execute in vivo experiments, conduct ex vivo analysis or in vitro experiments to address drug mechanism-of-action and disease-focused hypotheses, PK/PD relationships, data analysis and interpretation 
• Experience ensuring quality control and accurate analysis of data provided by CROs is a plus 
• ACUC experience (including ACUP authorship) and/or AAALAC experience is highly desired 
• Understanding of global health authority expectations for pharmaceutical development and registration, ideally across multiple, relevant therapeutic areas in regard to non-clinical, pharmacology  
• A commitment to collaborative leadership, management, teamwork, delegation and foster a professional culture based on trust and mutual respect 
• Exceptional organizational and presentation skills, including presentations to senior management and external audiences and experts  
• Ability to work across locations and time zones