Home Production Senior Manager - Clinical Pharmacokinetic Studies | Sun Pharma Advanced Research Company...

Senior Manager – Clinical Pharmacokinetic Studies | Sun Pharma Advanced Research Company | Vadodara

-

 

Founded in 1983, Sun Pharma IS NOW THE 5th Largest Manufacturer of Generics in the World, and No1 Company in India. Sun Pharma has above 40 Manufacturing Facilities in compliance with Regulatory Bodies like USFDA, MHRA, TGA, etc.

Join Us for Regular Vacancy Updates on

Join Our Telegram Group

Join Our Facebook Group
We owe our success to our passionate and skilled workforce. At Sun, one can work with an inspiring, approachable, and visionary leadership. Our open, enabling and trust-based culture will offer you an exciting environment to work and excel in your chosen career.

Position: Manager – Invitro Biology

Location: Vadodara, Gujarat, India

Job Description:

Roles & Responsibilities:

This is a position for a highly motivated individual who will be primarily responsible for designing and perform pharmacokinetic data analysis of phase 1 clinical PK studies, FIH (SAD/MAD), DDI, AME, and special population studies for new molecular entities. The individual would be responsible to integrate pharmacokinetic and metabolism data across clinical studies and performing PK modeling and simulations to support informed decision-making on appropriate doses, dosage forms, and regimens teams.

Key Responsibilities:

  • Design and provide synopsis/ study protocols for phase 2 clinical PK studies in collaboration with clinical, formulation, and regulatory teams.
  • Analyze PK data from phase 1 clinical studies using an appropriate software like WinNonlin, NONMEM, SPLUS or SAS and prepare study reports for regulatory submissions.
  • Development and application of PBPK or appropriate modeling tools for human PK and clinical DDI predictions
  • Collaborate with clinical pharmacology in the modeling of emerging PK and PK?PD data and exposure-response analysis to aid in the selection of appropriate dose, dosage form, and regimen
  • Responsible for authoring and/or reviewing relevant clinical pharmacology sections of the regulatory documents, such as IB, IND, labeling, and NDA.

Technical Skills:

  • Sound knowledge of pharmacokinetic and pharmacodynamics principles and overall ADME of small and large molecules
  • Strong modeling and simulation expertise in clinical PK and PK/PD.
  • Working knowledge of pharmacokinetics and clinical pharmacology discipline and its method and approaches
  • Must have hands-on experience with PK data analysis using data processing software such as Phoenix NLME, NONMEM, R, Gastro Plus, SimCYP, PUMAS, etc.

Qualification: M.Pharma, Ph.D

Experience: 8-13 Years

Salary: Negotiable

Contact Details:

Mr. Kushal Paliwal

hrd@sunpharma.com, kushal.paliwal@sunpharma.com

Click for More R&D Jobs


Join Us for Regular Vacancy Updates on –

Join Our Telegram Group

Join Our Facebook Group

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Must Read

Area Sales Manager | Venus Remedies Ltd | Jaipur, Hisar

0
For a quarter of a century, we have done the grunt work. We've consistently invested in R&D. We've innovated unique, patented products. We've painstakingly...