Kali Therapeutics · 9 hours ago
Director of Clinical Pharmacology
United States
Full-time
Remote
Lead/Staff, Director/Executive
5+ years expKali Therapeutics is focused on groundbreaking advancements in immunotherapy, specializing in T-cell engagers that aim to reset and regenerate the immune system. The Director of Clinical Pharmacology will support the clinical portfolio of biologic therapeutics, leading pharmacokinetic and pharmacodynamic analyses, and guiding dose regimen selections for clinical trials.
Biotechnology
Responsibilities
Represent Clinical Pharmacology and provide PKPD input to project teams
Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data
Conduct PK/PD analyses to guide development decisions on project teams
Develop model-based dose selection approach for pivotal clinical trials, while working in close partnership with (potentially external) pharmacometrics, clinicians and statisticians
May partner with preclinical functions to understand and interpret preclinical findings and their translation to clinical development on individual development programs as well as broader technology platform research initiatives
Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA
Design and oversee the conduct of clinical pharmacology studies (either standalone or within broader clinical trials) to generate high quality and relevant data
Network with external expert consultants, CRO partners and academic sites to problem solve and develop scientific solutions to clinical pharmacology issues
Lead and prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data
Participates in the preparation of abstracts and manuscripts for publication
Closely partner with Research, Bioanalytical, Clinical functions, Regulatory, Program Management, and other R&D functions
Qualification
Required
Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with extensive experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience with 5+ years of industry experience
Strong working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology
Proficient in using R, Phoenix WinNonlin, NONMEM, or other pharmacokinetic and modeling software
Strong communication skills (verbal and written) and presentation skills are required
Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential
Benefits
Medical, dental, and vision coverage for employees and their dependents
401(k) plans
Company
Kali Therapeutics
Kali - the Hindu goddess, embodies fierce power, destruction, and transformation, symbolizing the cyclical nature of creation and rebirth.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase