Director of Clinical Pharmacology - Global company
- Experience Level
- Experienced (non-manager)
As a Director of Clinical Pharmacology you will be providing scientific expertise and leading drug development through all program stages focusing on the design of clinical phase 1 and regulatory clinical pharmacology studies.
You’ll focus on complex programs, including those therapeutic areas with little or no clinical development precedence.
- Participate in medical and scientific literature review.
- Review preclinical and clinical safety and efficacy data of novel compounds including Investigator’s Brochures, if available, for the support of the design of clinical development programs and studies.
- Design / review the outlines of studies in the early clinical development plan, including ADME, PK and PK/PD studies and review study results and study reports.
- Prepare / review the delivery of relevant sections of Statistical Analysis Plans, PK/PD data analysis and statistical results, and PK/PD sections of Clinical Study Reports.
- Support the writing of clinical study protocols and study reports, and lead the writing when occasionally appropriate.
- Act as a client representative with regulatory agencies.
- Participate in Business Development activities and the RFP process (bid defenses, client consulting, support for full development programs and individual clinical studies).
- Guide the development of manuscripts and early clinical development, clinical pharmacology and/or PK/PD sections of regulatory submission documents.
- Ph.D. in Pharmaceutical Sciences or a health related field with emphasis in clinical pharmacology, pharmacokinetics (including ADME, biopharmaceutics, and pharmacometrics) and associated publications in peer-reviewed international journals.
- Clinical pharmacology experience in the setting of (bio)pharmaceutical or biotechnology companies.
- Demonstrated ability to plan, supervise, implement, and monitor the clinical pharmacology, PK and PD development and reporting processes for clinical trials.
- Excellent communication skills with demonstrated leadership ability.
- 10 years of working experience at large pharmaceutical company and/or small biotech.
Reach out to Antonia at Barrington James for more information
+44 1293 776644
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