This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP. Looking forward to hearing from you soon.
Work Location: Cambridge, MA
Job Title: Clinical Pharmacology Scientist III
Duration: 12+ months (extendable) contract on W2
Job Purpose:
Leads the PK Sciences strategy and influences project strategy during discovery and/or clinical program. Collaborates within the cross-functional team to identify and mitigate key project issues related to the PK Sciences discipline (PK, PK/PD, IG, metabolism and clinical pharmacology).
Major Accountabilities:
• Independently represents PK Sciences a core member of discovery, translational medicine and global project teams. • Participates or leads PKS sub-team to define PKS strategy for compound progression and development. • Manages study timelines, objectives and budgets, ensures accuracy of project progress in company tracking tools. • Responsible for the timely and effective communication of data, strategy, results, impact to the project teams. • Aligns plans and strategies with sub-teams, project teams, manager and leadership team. • Analyze and interpret PK/TK/PD/IG data generated during discovery, early and full development; present results to the program. • Proactively identifies potential project hurdles, provides solutions and contributes to contingency plans. • Independently authors and prepares key pre-clinical and clinical, and regulatory documents including, but not limited to: clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND / IMPDs and NDAs within agreed timelines, and meeting all regulatory requirements. • Actively participates in cross-departmental teams, department-wide initiatives and work streams. • Provide PK Sciences expertise on due diligence and prepare appropriate documentation. • Publishes internally or externally as main contributor to enhance Novartis and PK Sciences visibility. • May mentor and train other PK Science Associates. • Completes all required organizational trainings and requirements according to corporate timelines • Adhere in strict accord to the appropriate SOP and GxP guidelines.
Skills:
• Extensive understanding of drug metabolism and pharmacokinetic principles. • Good understanding of clinical pharmacology strategy in drug development and registration. • Experience in drug discovery characterization. • Proficiency with key software for PK analysis and PK modeling (e.g. Phoenix). • PK/TK study design expertise. • Clinical study design for clinical pharmacology studies. • Regulatory knowledge of area of CP & Biopharmaceuticals.
Education:
PhD / Pharm.D. level scientist with relevant experience in drug metabolism and pharmacokinetics or related biologic back ground.
--- Many Thanks,
Sree Kanth Recruitment Manager Sree@newageclinical.com
NewAgeSys, Inc. Direct: 609-945-1736 Fax: 609-228-4079 600 Alexander Rd, Suite 3-3 Princeton , NJ 08540 Visit our job boards for a listing of open positions. For IT Positions go to www.newagesys.com/career.html For Clinical Positions go to www.newageclinical.com/careers.html Inc 5000 Company for 8th Time!
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