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Title : NVG- Clinical Pharmacology Scientist III -397
State : Massachusetts   Date : Oct 22, 2020
Experience Level :  
Position Type : Clinical Pharmacology Scientist III      
Description
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. 



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

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