Clinical Pharmacology Fellow Job

CLINICAL PHARMACOLOGY FELLOW needed for a CONTRACT opportunity with Yoh's client located in EAST HANOVER, NJ.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Pharmacology experience
- Clinical study protocols, study reports, and modelling reports writing experience
- IND and NDA experience

WHAT YOU'LL BE DOING:

- Contribute to the design and coordination of pharmacokinetic/DMPK related elements for clinical projects.
- Identify potential project hurdles, suggest solutions and establish contingency plans.
- Represent Oncology Clinical Pharmacology (OCP) on clinical trial teams to support early or late stage clinical programs.
- Contribute expert input into key pre-clinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, modelling reports, investigator brochures, IND/IMPD's and NDA's within agreed timelines, and meeting all regulatory requirements under frequent guidance from manager.
- Facilitate constructive collaboration within drug development teams (GPTs, etc) and with other internal partners (eg DMPK, Toxicology, Formulations, Drug Regulatory Affairs, Clinical Development).
- Work with a senior colleague or supervisor to define and update as appropriate the PK, PK/PD, DMPK, biopharmaceutical and pharmacometric requirements in the OCP and/or pre-clinical project development plans.
- Monitor timelines, objectives and as appropriate, budgets.
- Ensure accuracy of project and activity progress in company tracking tools (eg, Succeed, ModTracker).
- Assure rapid and effective communication of high quality data and results to project teams with support of manager.
- Follow internal processes, adhere to company and project specific standards and when required, adhere to Health Authority requirements (SOPs, Master Analysis Plan, GCP, and regulatory guidelines).
- Contribute to writing and updating new processes and standards for OCP.
- Contribute to and participates in OCP or project sub-teams.
- Coordinates with appropriate subteam members and/or prepare summary documentation.
- Maintain and enhance technical and drug development expertise (eg training courses, external meeting attendance).
- Help conduct training/study sessions within OCP and for other line functions.
- Contribute to meetings with external parties including investigators and outside experts.

WHAT YOU NEED TO BRING TO THE TABLE:

- PhD. in a relevant discipline, Pharm D. with appropriate post-doctoral training, or equivalent experience.
- Zero to 10 (0-10) years of relevant academic, industry, or government experience
- Proficiency with pharmacometric tools (eg, WinNonlin, SAS, NONMEM, Trial Simulator, GastroPlus, SymCyp).
- Knowledge of related disciplines (eg, DMPK, biostatistics, toxicology, regulatory) in the drug development process.
- Ability to work as part of a cross functional team in a highly dynamic, matrixed, project-team environment.
- Strong oral and written communication skills.
- Strong organizational and project skills.
- Critical thinking and problem solving skills.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER:Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V

J2W: PROF, CLINCAL

MONJOBJ2WMIDATL

Ref:

SFSF: LS