Posted in Other 7 days ago.
Location: Rockville, Maryland
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
An American Company is seeking an Sr. Director/Director, Pharmacometrics in Rockville, MD.
Drug development and regulatory decisions are driven by information compiled primarily from clinical trials and other supportive experiments. However, it is also guided through clinical experience in the post-market period. Understanding these decisions determines the efficiency of drug development, the decision to approve the drug, and the resulting drug product quality, including guidance on using the product known as the label.
We use Pharmacometrics is an emergent science defined as the science that quantifies drug, disease, and trial information to aid efficient drug development. The result is to obtain the information required to approve and label our product with particular attention to drug dosing for all patients.
Reporting to the Vice President of Clinical Pharmacology and Pharmacometrics. In this position, Pharmacometrics is expected to provide strong technical and strategic leadership to the organization and strengthen and champion quantitative model-based drug development across the company. In addition, the successful candidate will be responsible for the pharmacometrics plan, conduct, and review of modeling analysis for internal decision making and regulatory filings. The candidate should possess scientific curiosity and a passion for quantitative science-based interrogation of data.
Major Duties and Responsibilities
• Strategize, formulate and execute on modeling and simulation strategy for clinical projects with the ability to independently plan, design, analyze, interpret and report PKPD modeling results for internal decision making and regulatory filings
• Train, mentor, and grow pharmacometrics team members in modeling and simulation skills.
• Responsible for identification of dosing regimen and optimization of dosing for our products
• Collaborate and influence decision making about dosing and clinical trial design on project teams
• Strategize, collaborate cross-functionally with other departments and provide modeling and simulation support
• Formulate pharmacometrics strategy and responses to regulatory health authority inquiries on P.K., PK/PD, dosing, and clinical pharmacology-related issues. Represent Pharmacometrics at regulatory meetings.
• Enhance role and visibility of Pharmacometrics internally and showcase our expertise through publications in peer-reviewed journals and presentations at scientific meetings
Skills & Requirements
• Ph.D., MD, PharmD in Bioengineering, Pharmaceutical Sciences, Pharmacology, Statistics, Applied Mathematics, Engineering, Medicine, or related field.
• At least ten years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments.
• Solid experience in Pharmacometrics, clinical pharmacology, pharmacokinetics, or a related discipline in a project team setting is preferred, whether in academia or industry
• At least ten years of pharmacometrics experience in the pharmaceutical industry or regulatory agency. Should have hands-on experience and should be intimately familiar with the drug development process
• Expert in modeling (e.g., Popp K and PK/PD analyses, model-based meta-analysis, dose-response, and exposure-response analyses, dataset creation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling).
You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
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Hays is an Equal Opportunity Employer.
Drug testing may be required; please contact a recruiter for more information.
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