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.

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). 

• 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.

PhD / Pharm.D. level scientist with relevant experience in drug metabolism and pharmacokinetics or related biologic back ground.