VP, Clinical Pharmacology, DMPK

Vice PresidentVice PresidentFull TimeRemoteLeadTeam 51-200Since 2017Company SiteLinkedIn

Location

United States

Posted

1 day ago

Salary

$275K - $300K / year

Seniority

Lead

Postgraduate Degree15 yrs expEnglish

Job Description

• 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.

Job 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

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