The Clinical Pharmacology Associate Director manages scientific and operational aspects at a study level and assists development at a program level. The role may represent the department on cross-functional study teams and contribute to clinical pharmacology plans. The role will provide expertise in clinical pharmacology concepts and applications.
Key Duties and Responsibilities:
- Assists in the development of clinical pharmacology at a program level and oversees study-related activities
- Contributes to clinical pharmacology plans and summary documents including drug-drug interaction, special population and safety studies
- Generates hypothesis and provides strategy for clinical pharmacology study types e.g., metabolic, drug-drug interaction issues, special populations collaborating closely with cross functional colleagues
- Creates protocol concepts and guides protocol start-up including site initiations
- Participates in study teams, oversees study progression including protocol conduct, data analyses, internal decision points and final reporting
- Monitors the progress of studies outsourced to contract research organization
- Co-leads or serves on cross-functional committees and/or contributes to or leads departmental initiatives
- Collaborates with other functions to guide program deliverables
- Performs advanced/complex PK and PK/PD or exploratory analyses or guide such analyses as appropriate
- Guides and/or assists with PK/PD modeling or simulations
- Prepares technical reports including clinical study reports
- Leads and contributes to publications and abstracts
Knowledge and Skills:
- Developed critical thinking skills, with keen scientific judgment
- Ability to work on cross-functional teams in a matrix environment
- Industry or regulatory experience preferred
- Experience conducting or supervising conduct of clinical studies such as drug-drug interaction, special population or bioavailability; supporting other studies such as first-in-human, proof-of-concept or pivotal studies; conducting or supervising conduct of non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic (PD) analyses; contributing to clinical and regulatory documents such as the Investigator’s Brochure and contributing to regulatory correspondence
Education and Experience:
- Ph.D. or Pharm D (or equivalent degree) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development and 5+ years of relevant post-doctoral employment experience, or
- Masters Degree (or equivalent degree) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development and 8+ years of relevant employment experience
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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.