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Director, clinical pharmacology skills for your resume and career
15 director, clinical pharmacology skills for your resume and career
1. Drug Development
- Designed and established company first pharmacology lab to facilitate aggressive preclinical drug development.
- Managed and coordinated program designed to support drug development research efforts.
2. Clinical Development
- Managed multidisciplinary resources from Discovery to Clinical Development in collaboration with Medicinal Chemistry and DMPK team leaders.
- Championed three research projects (fertility and men's urology) and which have advanced to Phase III clinical development.
3. Pharmacokinetics
- Experienced in due-diligence processes, assessing clinical translation of animal safety, physiology, and pharmacokinetics.
- Assisted in developing and utilizing different surgical and pharmacokinetic animal models to determine effects of different biological compounds.
4. PK/PD
- Managed CRO collaborations for outsourced projects for bioanalytical, PK, POP PK, PK/PD, and M & S activities.
- Dose escalation decision were based on PK/PD (biomarker) correlation and modeling.
5. Data Analysis
- Assisted in identification and prioritization of data analysis and publication planning.
- Conduct data analysis, interpretation, present data, and generate reports for above mentioned studies.
6. NDA
A non-disclosure agreement, also called a confidentiality agreement, refers to the constitutional paperwork that compels two parties to keep each other's data fully confidential. Trade secrets and different types of sensitive data are kept secure via an NDA. If one party doesn't keep up his end of the bargain, they will break the law and may face charges.
- Participated in the development of NDA including general medical report and safety summaries.
- Performed reconciliations on National Cancer Institute's old clinical trial data, resulting in an NDA.
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- Championed life cycle management for reboxetine for psychiatric and pain indications.
- Demonstrated successful partnership with Organon; completed positioning of preclinical pharmacology package, life cycle management and publication goals.
8. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Represented clinical pharmacology at the FDA meetings and teleconferences on Overactive Bladder.
- Recruited to the position to achieve and maintain regulatory compliance (FACT, FDA, CLIA).
9. Clinical Trials
- Analyzed data from clinical trials (food interaction, drug interaction and mass balance studies).
- Managed global multi-center Phase II, and III Clinical trials in Oncology (Solid tumors and Heme/Onc) MDS/AML and CLL.
10. Clinical Study Reports
- Designed clinical studies and authored clinical study protocols, investigator's brochure and clinical study reports.
- Completed trials/database closeout and prepared clinical study reports on-time, within budget for regulatory submission.
11. Biomarkers
Biomarkers, also known as biological markers, are measurable characteristics of a body that tells or describes one's condition. They play a significant role in the medical field as they can help physicians diagnose and treat different kinds of medical issues and concerns. Biomarkers may also be associated with blood pressure, cholesterol levels, x-rays, scan results, blood and urine tests, and body mass index.
- Served on the Wyeth Biomarker Assay Validation Committee to review every assay presented by vendors for many new biomarkers.
- Investigated correlations among exposure, efficacy, biomarkers and adverse events as well as dose reduction for dose/regimen selection and optimization.
12. Development Programs
Development programs are steps of activities backed up by a strategic plan of structured programs to yield, positive developmental outcomes. Development programs can be in various forms, and they spread across employee development, child development, and social development.
- Provided clinical pharmacology, PK/PD support for small molecule and biologic development programs in the field of oncology.
- Work includes detailed analysis of available data to identify key de-riskingstrategies and the optimum development program including capacities and cost.
13. ADME
- Prepared and presented clinical study synopses (DDI and ADME) to Senior Review Committee for approval and protocol development.
- Managed the overall annual budget for ADME activities to within 7.5% of the approved budget.
14. Clinical Program
A clinical program is the sum of all clinical services rendered to patients directly in a clinical setting. It also refers to the programs in a school setting that offers practical knowledge and exercises to students in clinical sciences who are under supervision by a licensed clinical practitioner. Clinical programs expose students to first-hand medical experience, and prepare them for the task ahead.
- Managed and supervised 10 Clinical Research Managers/Specialists that implemented/executed Clinical Programs in Oncology therapeutic area.
- Developed financial/clinical plans to meet short- and long-term objectives of clinical programs.
15. Translational Medicine
- Helped form and was part of management structure for the newly formed Translational Medicine Group.
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List of director, clinical pharmacology skills to add to your resume

The most important skills for a director, clinical pharmacology resume and required skills for a director, clinical pharmacology to have include:
- Drug Development
- Clinical Development
- Pharmacokinetics
- PK/PD
- Data Analysis
- NDA
- Cycle Management
- FDA
- Clinical Trials
- Clinical Study Reports
- Biomarkers
- Development Programs
- ADME
- Clinical Program
- Translational Medicine
- Clinical Pharmacology Sections
- CNS
- Data Management
- Drug Candidates
- GLP
- Neuroscience
- Hypertension
- Animal Models
- Strategic Direction
- Infectious Disease
- Animal Studies
Updated January 8, 2025