Associate Director, Clinical Pharmacology
Our Clinical Pharmacologists support the design, execution, and management of high quality clinical pharmacology/DMPK studies in humans, and consult with colleagues on the same in animal studies. Clinical Pharmacologists participate as key members of clinical development teams as they provide strategic clinical pharmacology guidance and operational support.
- Assists in writing and compiling reports and other documents summarizing advice and interpretation to the teams.
- Contributes to study documentation including synopsis, protocol, investigator brochure and report writing.
- Performs non-compartmental analyses (NCA), creation of tables, figures and listings (TFL), authoring of pharmacokinetic (PK) sections in Clinical Study Report, Regulatory Modules, PK analysis plans and FDA summaries.
- Works collaboratively with the development team to ensure an adequate IND/First in human enabling packages, back translation of Clinical PK/ADME data and PK-PD relationships.
- Exploring/contribution in insourcing and outsourcing certain aspects of pharmacometric work, including data management and routine pharmacometric analysis.
- Reviews regulatory publications to keep apprised of new regulatory developments and tracks recent regulatory approvals.
- Co/authoring peer-reviewed manuscripts and publications.
- Conducts quality control and quality assurance activities on data sets and reports.
Required Experience and Expertise
- PhD, PharmD degree or equivalent with specialization in pharmacology or pharmacokinetics, or in a related scientific discipline.
- Minimum 1- 5 years’ experience and expertise in clinical PK analysis, data management, reporting writing, and regulatory requirements – experience in academia or industry may be acceptable.
- General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology is preferred.
- Functional understanding of the application of a broad range of clinical pharmacology tools such as, but not limited to Phoenix WinNonLin (or other similar PK analysis tools), NONMEM, S-Plus/R and other PK/PD analysis software.
- Entry level developing modeling skills preferred.
- Proficiency in performing PK and statistical analysis and dataset construction.
- Experience with in vitro DMPK data generation and interpretation with a focus on DDI and transporter guidance requirements is preferred.
- Some experience as an applied development practitioner in both design and stewardship of clinical pharmacology components of clinical development plans preferred.
- Advanced user of MS Office products including Outlook, PowerPoint, Excel, and Word.
- Excellent written, verbal and inter-personal communications skills.
- Ability to support and coordinate multiple projects as requested.
- Must work well with a team in a multidisciplinary environment.
- Flexibility and confidence to handle ambiguities, changing demands and priorities.
- Shows critical thinking, creativity, initiative and conscientiousness.