Principal Scientist Clinical Pharmacology at Merck Specialities Pvt. Ltd.

Bangalore, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

11 Jul, 26

Salary

0.0

Posted On

12 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Pharmacology, Pharmacokinetics, ADME, Posology, Quantitative Translational Sciences, Non-compartmental PK Analysis, Phoenix WinNonlin, R, Clinical Study Protocols, Regulatory Documentation, GXP, Data Analysis, Clinical Research, Communication, Presentation Skills, Organizational Skills

Industry

Chemical Manufacturing

Description

Join Our Team as a Principal Scientist/Clinical Pharmacology! In your role as a Principal Scientist/Clinical Pharmacology, you will drive study-level clinical pharmacology deliverables, contributing directly to the successful execution of clinical study objectives. Collaborating with the Clinical Pharmacology Expert Team (CPET) Lead, you will align on the clinical pharmacology strategy, ensuring effective integration into study design and execution. Responsibilities include performing, interpreting, and reporting non-compartmental pharmacokinetic data analyses. As a member of the CPET, you will support dosing and posology decisions from first-in-human starting dose to launch, while also contributing to clinical pharmacology components in major clinical and regulatory documents, ensuring alignment with global submission standards. This is your chance to apply your knowledge and passion for clinical pharmacology and pharmacokinetics to advance therapies that can improve healthcare. Location - Bangalore/Mumbai/Hydrabad Who You Are You are a dedicated professional with a strong background in clinical research and data analysis. To excel in this role, you should possess: • PhD with 2+ years of experience or Master's degree in Life Sciences (e.g., Pharmaceutical Sciences, Pharmacology) with 6+ years of postgraduate experience in a related field • Deep knowledge of clinical pharmacology, including PK, ADME, posology, and quantitative translational sciences • Competence in the preparation of clinical study documents e.g., clinical pharmacology components into clinical study protocols, analysis plans and reporting across a various study design including healthy volunteer and patient studies. • Hands-on experience with non-compartmental PK analysis (e.g, Phoenix WinNonlin and R). • A strong understanding of clinical drug development strategies and quality requirements in GXP-related areas. • Excellent presentation, communication, and organizational skills, with the ability to convey technical results clearly to stakeholders.

Responsibilities

The Principal Scientist will drive clinical pharmacology deliverables and collaborate with the Clinical Pharmacology Expert Team to align on study strategy. Responsibilities include performing pharmacokinetic data analyses and contributing to clinical and regulatory documentation to ensure global submission standards.