• 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

Minimum Qualifications :

• Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or other life sciences with 10+ year's experience in the Biotechnology/ Pharmaceutical Industry or post-doctoral training.

• People Management experience preferred.

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Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.