Job Description:

Vertex Pharmaceuticals, Inc. is looking for a Clinical Pharmacology leader to join the team in Boston, MA. The Clinical Pharmacology leader is a highly scientific role, supporting multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. He/She will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed. The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, and DDI, as well as a good understanding of related disciplines such as pharmaceutical development, regulatory, and overall drug development.

Key Responsibilities:
  • Performs analysis of clinical pharmacology data (PK/PD) from phase 1-4 clinical studies with minimal supervision.
  • Develops clinical pharmacology data analysis plans with minimal supervision.
  • Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions.
  • Provides complex clinical pharmacology input to clinical development plans, Investigator s Brochure and Clinical Pharmacology section of INDs, CTAs and/or NDAs with supervision.
  • Leads study conceptualization, protocol development, and study start-up activities, including site initiation and investigator meetings.
  • Prepares responses to inquiries from regulatory agencies with minimal supervision
  • Provides scientific and technical input about clinical pharmacology-related issues within project teams, as assigned.
  • Provides program development support with a higher level of oversight.
  • Collaborates with colleagues in bioanalytics, biometrics, clinical development, drug metabolism and pharmacokinetics, toxicology, and regulatory affairs for clinical studies.
  • Demonstrates a good understanding of the requirements of the study design, conduct, analysis and report writing for regulatory submissions.
  • May have direct reports

Qualification:

Minimum Qualifications:
  • Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or other life sciences with 8+ year s experience in the Biotechnology/ Pharmaceutical Industry or post-doctoral training.

Preferred Qualifications:
  • People Management experience preferred.

Associated topics: diet, histologist, immunoassay, medical, metabolism, nutrition, nutritionist, protein, trauma, vaccine

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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