Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Sr. Clinical Pharmacologist at a prestigious Fortune 500® company working in Foster City.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position (Brooke.Schoen@kellyservices.com) however your resume must be received via the “Submit Resume” button included within.
Job Title: Sr. Clinical Pharmacologist
Pay: $62 per hour
The position is responsible for efficient, innovative, and timely clinical PK, PK/PD, and/or population PK study design, analysis, interpretation, and reporting of clinical studies to support international regulatory submissions.
Your tasks and responsibilities will include;
o Provide small and large molecule clinical pharmacology expertise/support in the preparation of regulatory submissions (e.g. IB, IND, NDA).
o Performs pharmacokinetic analysis, interpretation, and reporting of data from clinical studies.
o Responsible for design, analysis and communication of data on clinical pharmacology studies. o Develops and implements new clinical pharmacology studies that impact development programs.
o Effectively represents clinical pharmacology in cross-functional study-team settings.
o Works in close partnership with Quantitative Pharmacology, Bioanalytical Chemistry, Project Management, Clinical Research, Biostatistics and Clinical Trials Management functional areas to support clinical development programs.
o Conducts clinical pharmacology studies in line with clinical PK and product development strategies.
o Designs and works with CRA regarding implementation and conduct of clinical pharmacology studies.
o Analyzes, interprets, and writes reports for clinical and regulatory submissions. Ensures the quality of patient care and adherence to scientific, safety and regulatory standards.
o Assists with managing timelines and budgets to insure prompt and accurate execution of clinical studies.
o Analyzes moderately complex problems in component parts and to identify causal relations.
o Contributes to and represents department on multifunctional project teams.
Specific education, experience and skills required for this role;
o PharmD, PhD, with pharmacokinetic training, fellowship and/or postdoctoral experience and 2+ years of clinical pharmacology/pharmacokinetics.
o Excellent verbal, written, and interpersonal communication skills and ability to convey moderately complex technical information clearly to others are required.
o In-depth knowledge and understanding of pharmacokinetic regulatory requirements for US and EC are required.
o Working knowledge of pharmacokinetic program and analysis software (such as WinNonlin, SAS etc.) along with PK modeling and computer skills in scientific graphing.
o Strong understanding of clinical pharmacokinetic concepts is required.
o Training/experience in advanced pharmacokinetics, clinical pharmacology and/or pharmacy with clinical research, drug development is desirable.
o Understanding of drug development process to provide clinical pharmacology support for clinical development (Phase 1 to Phase 4) for investigational agents and/or marketed drugs.
o Hands-on experience in clinical trials management/study conduct and/or basic laboratory sciences is desirable.
o Must have established computer skills with detailed knowledge of PK programs and analysis software (e.g. WinNonlin), along with experience with scientific graphing and analysis software (Sigma plot, GraphPad, Instat, etc). Must have excellent written and verbal communication skills.
o Must have excellent interpersonal, written and verbal communication skills.
o Must have critical thinking skills and ability to make decisions
o Demonstrate ability to work independently
o Exhibit excellent written and verbal data presentation skills to enable contribution to internal/external teams, conference presentations and publications
We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com.
Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
Kelly Services is an Equal Opportunity Employer
With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
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Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.