Director of Clinical Pharmacology

About the Role

Kali Therapeutics embodies transformation and renewal, inspired by the Hindu goddess Kali, symbolizing power and rebirth. Focused on groundbreaking advancements in immunotherapy, Kali Therapeutics specializes in T-cell engagers that provide precise targeting and controlled cytotoxicity. These innovative therapies aim to reset and regenerate the immune system, driving transformative outcomes in healthcare. The company is at the forefront of developing next-generation treatments that address critical medical needs.

About The Role

The (Sr/Assoc) Director, Clinical Pharmacology supports an expanding clinical portfolio of biologic therapeutics. Responsible for dose regimen selection for first-in-human studies using preclinical data or later phase clinical studies, including conduction and/or supervision of PK/PD analyses for clinical trials, as well as clinical pharmacology strategic and tactical aspects.

• 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.

• 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 Win Nonlin, 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.

Kali is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. At Kali we engage in equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization.

We take care of our employees with a competitive benefits package that includes medical, dental, and vision coverage for employees and their dependents, as well as 401(k) plans.

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