Director, Clinical Research Scientist - United States
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- Clinical Scientists within Clinical Pharmacology are responsible for providing the clinical pharmacology components of clinical plans and providing clinical pharmacology expertise to the project team.
- The Clinical Scientists will utilize innovative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and diseases for rational development strategies and decisions, as well as optimal study designs and dosage regimen selections.
- This position is responsible for planning, implementation, managing, and reporting of clinical pharmacology trials while closely working with physicians, statisticians, pharmacokineticists, translational medicine, CMC, toxicology and other scientists within drug discovery.
- Accountable and responsible for the clinical pharmacology deliverables.
- Development of clinical pharmacology development plans.
- Author protocols for clinical pharmacology studies and contribute to other clinical study protocols.
- Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other FDA submissions.
- Design clinical pharmacology/exploratory development studies.
- Review SAPs and tables, listings, and figures.
- Review and summarize safety data in ongoing studies.
- Represent clinical pharmacology on project teams.
- Work closely with Clinical Operations and Project Management to ensure timely implementation of Clinical Pharmacology studies.
- Develop relationships with appropriate consultants.
- Write abstracts and present data at scientific meetings.
- Serve as liaison to project teams, CRO’s and others.
- Preparation of clinical pharmacology NDA documents.
Minimum Requirements and Experience
- Pharm.D. or Ph.D. or M.D. in Pharmacology/Pharmacy/Biological Sciences.
- A minimum of 5-10 years’ experience in pharmaceutical industry with at least 5 or more years of hands-on clinical pharmacology experience.
- Demonstrated ability to effectively present clinical pharmacology data, development plans and strategies to various audiences in both verbal and written form; demonstrated ability to write clinical pharmacology results and conclusions for reports and regulatory documents that are clear and concise.