Director, Clinical Pharmacology
Our client is a biotechnology company. They have asked us to assist them in a search for a Director, Clinical Pharmacology.
Major tasks and responsibilities include:
- Drives development and execution of the Phase 1 clinical studies and PBPK and PKPD modeling, activities within assigned programs to yield high value of pharmacokinetic, pharmacodynamic and drug metabolism insights for future critical decisions.
- Develops and maintains strong knowledge of best regulatory practices, clinical pharmacology principles, PK and PD analysis methodology, and drug development precedent.
- Analyzes data, interprets results, and authors clinical pharmacology related documentation including clinical protocols, study summaries, interim reports, abstracts and manuscripts, presentations, clinical pharmacology components of investigator brochures, other IND and NDA documents, and various other internal and external documents and communications as needed.
- Assures cross functional alignment for clinical pharmacology studies and activities with other functional areas involved in clinical development programs.
- Helps to develop operational strategies for clinical pharmacology studies.
We see candidates with the following qualifications:
- Participates in preclinical DMPK evaluation of new drug entities including human dose prediction.
- An MSc or PhD in clinical pharmacology, pharmacokinetics, biopharmaceutics or a related field is required.
- Must have a minimum of 5 or more years of experience working as a clinical pharmacologist, DMPK or pharmacometrician within the biotech or pharmaceutical industry.
- Must have demonstrated expertise in the design, conduct, analysis and reporting of clinical pharmacology studies.
- Requires competency in understanding and supervising PK and PK/PD activities related to noncompartmental modeling including population PK/PD analyses and simulation.
- Experience with advanced PK/PD models is required.
- A thorough command of pharmacokinetics and pharmacodynamics and their integration in the clinical drug development process is required.
- Requires substantial technical writing experience. Documented first authorship of protocols, study reports, regulatory communications, manuscripts, IND and NDA submission experience is preferred.
- Excellent written and verbal communication, presentation, and organizational skills are required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms
and Forbes' list of Top 200 Best Executive Recruiting Firms