Scientist II (PK/PD)

Cross project Clinical Pharmacology support for late stage clinical programs.

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, modeling 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 (e.g. 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 (e.g., 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 Client 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 (e.g. 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.

Languages:

Fluent English (oral and written)

Experience/Professional requirement:

1. 0-10 years of relevant academic, industry, or government experience

2. Proficiency with pharmacometric tools (e.g., WinNonlin, SAS, NONMEM, Trial Simulator, GastroPlus, SymCyp).

3. Knowledge of related disciplines (e.g., DMPK, biostatistics, toxicology, regulatory) in the drug development process.

4. Ability to work as part of a cross functional team in a highly dynamic, matrixed, project-team environment.

5. Strong oral and written communication skills.

6. Strong organizational and project skills.

7. Critical thinking and problem solving skills.

Education:.

Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral training, or equivalent experience.

Best Regards,

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960