Principal Scientist/Associate Director, Translational PK/PD
Crinetics Pharmaceuticals is seeking an experienced scientist to join its growing and dynamic development team. This individual will be responsible for the management of outsourced bioanalysis and biomarker activities including assay selection, development, validation, and utilization in nonclinical and clinical development. The work will support projects at various stages of development thereby allowing the selected candidate to play an active role in our drug discovery and development efforts to advance small molecule therapeutics for rare endocrine disorders and endocrine-related cancers. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community. (Position will be filled at level commensurate with experience.)
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
- Contribute to translational PK/PD strategy to support the clinical development plan and program goals.
- Derive a First-In-Human maximum recommended starting dose and pharmacologically active dose based on well established in vitro to in vivo and/or allometric scaling approaches.
- Predict human exposure (PK) and pharmacodynamic (PD) biomarker-based response for early clinical trials.
- Based on the animal model data and early clinical trials, explore mechanistically the effects on target and pathway to understand the requirements for demonstrating efficacy in human.
- Drive learning through back translation of early clinical PK/PD data and providing prioritized future options for clinical testing.
- Provide translational PK/PD expertise to the project team and closely collaborate with in vivo Pharmacology and Clinical Sciences.
- Identify, develop, and implement new ideas based on PK/PD data analysis outcomes.
- Lead the collaborative with team members and consultants/vendors to execute appropriate PK-PD analysis.
- Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to insure integration of modern clinical pharmacology principles into project plans and study design.
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
- Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a strong understanding of DMPK and pharmacology/safety aspects of drug discovery and development.
- Significant industry experience (Principal Scientist: Ph.D. with 5+ years of experience, MS with 7+ years of experiences; Assoc. Director: Ph.D. with 8+ years of experience, MS with 10+ years or experience) in conduct and/or oversight of modeling and simulations in both nonclinical and clinical setting.
- Prior experience in translational PK/PD analysis using modern data analysis tools, such as Phoenix NLME, NONMEM, R/S-Plus or related software with requisite programming skills is required.
- Ability to independently design studies and data analyses to characterize PK and PK/PD relationships of clinical development compounds.
- Prior experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions is preferred.
- Experience in working in a cross functional team and matrix environment.
- Strong written, presentation and verbal communication skills.
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint), Phoenix WinNonlin. Knowledge of other software required: GraphPad Prism, NONMEM, R/S-Plus.
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.
Travel may be required up to 10% of your time.