Job Summary

NiKang Therapeutics has an opening for the Director, Clinical Pharmacology. In this position, you will report to the Vice President, Clinical Pharmacology & DMPK. You will be responsible for the Clinical Pharmacology plan for assigned projects and serve as the Clinical Pharmacology lead in project and study teams. You will collaborate with cross-functional teams to identify and mitigate challenges related to all aspects of clinical pharmacology.

This will be a remote working position that requires minimal travel.

Essential Duties and Responsibilities

• Draft and update Clinical Pharmacology plans and design Clinical Pharmacology studies
• Apply model-informed drug development for dosage optimization at all stages of clinical development based on nonclinical and clinical data
• Contribute to key clinical and regulatory documents (e.g., study protocols, study reports, IBs, DSURs/PSURs, INDs, NDAs, MAAs) and address Clinical Pharmacology-related regulatory questions
• Partner with cross-function teams to advance projects
• Oversee outsourced Clinical Pharmacology related work

JOB QUALIFICATIONS

• Ph.D. or Pharma D. degree in pharmacokinetics, clinical pharmacology, or relevant biological sciences with at least 6 years of experience of pharmacokinetics and clinical pharmacology in the small molecule drug development
• Well informed with the current FDA, EMA, ICH guidances on DMPK and Clinical Pharmacology
• Extensive experience in designing clinical PK protocols, performing PK/PD analysis, and interpreting the impact of study results on clinical programs
• Hands-on experience in quantitative modeling methods (e.g., population PK, exposure-response analysis, PBPK) and modeling tools (e.g., NONMEM, WinNonlin, R, etc.)
• At least 5 years working experience in oncology and/or anti-inflammation drug development
• Hands-on experience in NDA/MAA filing and regulatory interactions are highly preferred, but not required.
• Strong trouble shooting and problem-solving skills and ability.
• Capability to mentor junior scientists and provide cross-functional education.
• Excellent oral and written communication skills and an ability to influence.
• Good network with scientific leaders and CROs.

NiKang Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.