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Title: Associate Director of Clinical Pharmacology
Hiring Organization: Connexion Systems & Engineering
Our client is seeking: Associate Director of Clinical Pharmacology
Compensation, Benefits, and Employment Type
- Duration – Contract – 10 months+
- Pay rate: 90-93/hr.
- Job Location: San Francisco, CA
- Job#: bh11843
This position is responsible for all aspects of the clinical pharmacology and translational medicine strategies for candidate drug products from early development (pre-IND) through late stage development (Phase 3 and NDA filings) using pharmacokinetic, pharmacodynamic, DMPK, and drug therapeutic principles, and knowledge of drug regulatory processes.
Will be responsible for providing Clinical Pharmacology support to clinical trials. Develop clinical pharmacology plans, design and direct clinical pharmacology studies, and work cross-functionally to establish clinical protocols. Provide scientific leadership in the preparation, conduct and reporting of clinical pharmacology studies. Independently write DMPK, pharmacology, and clinical pharmacology study reports and summarize them for regulatory submission documents. Integrate and interpret nonclinical and clinical pharmacology, DMPK, and translational medicine knowledge and prepare nonclinical and clinical pharmacology part of project and regulatory documents (IND, IMPD, IB, NDA CTD) and defend package in interactions with Regulatory Agencies. Collaborate with pharmacometricians in the modeling of emerging PK and PK/PD data. Serves as resource for information regarding nonclinical pharmacology, pharmacokinetics, drug metabolism, and bioanalysis within development organization and to regulatory authorities. Participate in writing publications and making scientific presentations consistent with development strategies. Maintain knowledge of relevant scientific and regulatory practices and trends, and ensure that clinical pharmacology aspects of development programs are contemporary.
Candidate must have direct experience in creation of regulatory submissions; experience interacting with regulatory authorities desired. Must have experience across the range of development phases. Excellent written and verbal communication skills, leadership, initiative and commitment to excellence are required; must be able to independently create high quality written reports and summary documents for use in regulatory submissions. Must have hands-on experience with data analysis, non-compartmental and compartmental PK/PD analysis and using data processing software such as Phoenix WinNonlin, R. Good working knowledge of graphing software such as SigmaPlot, Prism, JMP, R or Origin is required. Understanding of oncology therapeutic area highly desired. Desire to work in a cross-functional drug development team environment with all levels of employees and management; ability to lead such teams is valued.
Education: PhD in pharmacokinetics, pharmacology, pharmacy, pharmaceutical sciences or closely related discipline is required. Equivalent experience may be accepted. A minimum of 10 years pharmaceutical industry experience in designing, analyzing, interpreting, and reporting nonclinical and clinical drug development studies is required.
- CLINICAL PHARMACOLOGY
- CLINICAL TRIALS
- DATA ANALYSIS
- DRUG DEVELOPMENT
- DRUG METABOLISM
- DRUG REGULATORY
- EXCELLENT WRITTEN
- EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
- REGULATORY DOCUMENTS
- MARKETING ANALYSIS
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