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Position:
Director DMPK

Employer:
Nikang Therapeutics

Description:

We are looking for a DMPK Director to support NiKang’s growing pipeline of small molecules at different stages ranging from drug discovery, IND-enabling, to clinical development. The focus of the DMPK Director will be to lead all aspects of DMPK contributions across NiKang’s drug discovery and development portfolio. This position will collaborate with and influence cross-functional teams to identify and mitigate challenges related to PK, metabolism, assessment of DDIs, IND-enabling ADME, toxicology, PK/PD studies, and human dose projections. Additionally, this role will assist with the development of scientific strategies and continue to build partnerships cross-functionally to advance both NiKang’s research and clinical programs.

We are seeking a capable and highly motivated Director of DMPK to join our growing team, reporting to VP, Clinical Pharmacology and DMPK. In this role, you will be an essential part of an interdisciplinary team of highly talented and collaborative individuals, leading all DMPK-related support of IND-enabling and clinical-stage projects.  You will be a key leader in the vertically integrated DMPK and Clinical Pharmacology team, interacting with cross-function teams. You will be responsible for DMPK plans, group budget, and CRO collaboration to advance NiKang’s preclinical and clinical programs.

Essential Duties and Responsibilities

  • Lead DMPK activities across multiple project phases, including leading IND-enabling and clinical stage DMPK work and providing expertise to cross-functional teams to advance discovery to clinical programs.
  • Work very closely with clinical pharmacology to ensure integrated and synchronized DMPK and clin pharm transition and collaboration. Partner with and support discovery, chemistry, biology, toxicology, CMC, clinical, regulatory, clinical operation, biostats, and regulatory teams.
  • Design and execute preclinical studies to understand the PK and ADME of drug candidates. Provide expertise in human PK and dose prediction of drug candidates using different approaches.
  • Oversee the analysis, interpretation, and reporting of preclinical DMPK data generated both internally and using external vendors.
  • Manage CROs for the conduct of in vitro and in vivo ADME studies.
  • Author high-quality regulatory documents including INDs, IBs, clinical protocols, NDAs/MAAs, DSURs/PSURs, other regulatory documents, as well as scientific publications.


Qualifications/Experience:
  • Ph.D. in Drug Metabolism, Pharmacokinetics, or a related scientific discipline, with a minimum of 5+ years of relevant industry experience.
  • Experience in serving as the lead ADME/PK representative and interacting with discovery and development teams.
  • Strong knowledge of drug metabolism and pharmacokinetics principles; strong trouble shooting and problem-solving skills and ability.
  • Strong experience in planning and designing DMPK studies, proficiency in DMPK data analysis, and hands-on experience in integrating IND-enabling study results to author INDs.
  • Deep understanding of regulatory guidance on PK, DDIs, QT prolongation, BA, IND, etc.
  • Previous experience in NDA/MAA filing and regulatory interactions are preferred, but not required.
  • Demonstrated capability to mentor junior scientists and provide cross-functional education.
  • Good network with scientific leaders and CROs.
  • Excellent oral and written communication skills and an ability to influence.
  • The position is remote and requires minimal travel.

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.

 



Location: Flexible

Contact: jim.xiao@nikangtx.com

Post Date: 7/9/2022 10:50:35 AM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 10/7/2022; Admin Logon
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