VP, Clinical Pharmacology, DMPK
NiKang Therapeutics Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $275,000 - $300,000 per year
Job Level
About the role
- Provide strategic leadership and scientific expertise in clinical pharmacology and drug metabolism and pharmacokinetics (DMPK).
- Guide drug development programs from early discovery through late-stage development and commercialization.
- Provide integrated Clinical Pharmacology and DMPK plans for late-stage discovery and clinical projects.
- Execute related DMPK and clinical pharmacology studies and interpret study results.
- Collaborate cross-functionally as well as with external KOLs, consultants, and collaborators.
- Represent clinical pharmacology and DMPK expertise on cross-functional project teams and with external stakeholders.
- Advocate for and implement model-informed drug development (MIDD) principles across the organization.
- Design and interpret clinical pharmacology studies, including pharmacokinetic (PK) and pharmacodynamic (PD) studies.
- Lead the development of clinical pharmacology plans and content for clinical and regulatory documents.
- Collaborate with cross-functional teams to ensure seamless integration of clinical pharmacology and DMPK activities.
- Stay abreast of advancements in clinical pharmacology and DMPK science.
Requirements
- PhD. in Pharmacology, Pharmaceutical Sciences, or related field or Pharm D.
- A minimum of 15 years of relevant industry experience in the field of oncology drug development.
- Hands-on experience serving as clinical pharmacology lead for various types of clinical pharmacology studies.
- Hands-on experience developing PK/PD strategy for early-stage oncology programs.
- Thorough understanding of DMPK and clinical pharmacology principles.
- Experience with model-informed drug development (MIDD) is highly desirable.
- Familiarity with common software, e.g., WinNonlin, NONMEM, etc.
- Strong understanding of regulatory requirements for clinical pharmacology and DMPK studies.
- Direct experience interacting with FDA and EMA.
- Hands-on experience with clinical and regulatory documents including NDA, MAA, IND, IB, CSR, etc.
- Excellent communication, interpersonal, and presentation skills.
- Ability to successfully work remotely and travel ~10%.
Benefits
- eligibility to participate in a company-sponsored 401(k) program
- Paid Time Off benefits
- eligibility for medical, dental, vision benefits
- flexible benefits
- short-term disability and life insurance benefits
- annual discretionary bonus
- potential equity awards
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical pharmacologydrug metabolismpharmacokineticspharmacodynamicsmodel-informed drug developmentPK/PD strategyDMPK principlesclinical pharmacology studiesregulatory documentsoncology drug development
Soft Skills
strategic leadershipcollaborationcommunicationinterpersonal skillspresentation skills
Certifications
PhD in PharmacologyPhD in Pharmaceutical SciencesPharm D