02 Aug
|
Feathersoft Info Solutions
|
Kochi
02 Aug
Feathersoft Info Solutions
Kochi
Job Summary
Job Title: PK/PD Scientist/Sr. Scientist/Principal Scientist (PhD/MS) Location: Kochi, Chennai and Bengaluru
Job Type: Full-time
Department: Translational Research
Position Summary
We are seeking a highly motivated individual with expertise in preclinical and clinical pharmacokinetic, pharmacodynamic (PK/PD) and bioavailability modeling with passion for translational research.
Responsibilities
- 1. Hands-on experience in analyzing and interpreting pharmacokinetic (PK) and pharmacodynamic (PD) data from preclinical studies for clinical translation.
- 1. Support PK/PD assessments, data reviews, and scientific evaluations to support drug development research.
- 1. Is an active user of publicly available PK/PD data with a deep understanding of models used for predicting PK/PD from chemical structure of the drug.
- 1. Work with the team to identify data sources, participate in data validation, quality checks, and maintain the integrity and accuracy of PK/PD datasets.
- 1. Expertise in using PK/PD modeling and statistical tools to support data analysis for internal and commercial projects.
- 1. Closely work with the science and the AI team to set up methods to validate PK/PD models, and their outputs.
- 1. Provide guidance to convert PK/PD concepts, workflows, and scientific requirements into software features and product functionalities.
- 1. Conduct literature reviews and summarize scientific publications relevant to PK/PD, Clinical Pharmacology, and Drug Development to create an internal knowledge library.
- 1. Prepare technical reports, study summaries, scientific presentations, and supporting documentation.
- 1. Ensure compliance with company SOPs, GCP,
and applicable regulatory guidelines.
- 1. Maintain accurate documentation and support audit readiness activities.
Collaboration Project Management
- 1. Work closely with cross-functional teams, including disease domain experts, AI and software scientists, and clinicians to enable integration of PK/PD models into integrative solutions.
- 1. Communicate findings effectively through reports, presentations and discussions with internal teams and external collaborators.
- 1. Present work in internal research meetings.
- 1. Contribute to grant applications and funding proposals where relevant.
Qualifications Experience
- 1. PhD./MSc in Pharmacy, Pharmacology, Pharmaceutical Sciences, Clinical Pharmacology.
- 1. 3 years (PhD) - 5 years (MSc) hands on experience in a preclinical or clinical PK/PD group preferably in Pharmaceutical companies or small chemistry-focused service companies/CRO.
- 1. Must be part of a PK/PD team working with small molecule therapeutics and/or biologics
- 1. Experience in preparing preclinical and/or clinical documents for regulatory reviews
- 1. Broad understanding of drug development and methodologies employed for PK/PD modeling from experimental data.
Required Skills
- 1. Valuable understanding of Pharmacokinetics (PK), Pharmacodynamics (PD),
Clinical Pharmacology, and ADME principles.
- 1. Understanding of clinical research, drug development processes, and clinical trial methodologies and how PK/PD/bioavailability data is used for dose determination
- 1. Ability to analyze and interpret raw PK/PD data to calculate exposure, drug clearance, tissue penetration and other parameters.
- 1. Applying PK/PD knowledge to develop AI-based solutions for pharma and biotech use.
- 1. Strong analytical, problem-solving, and critical-thinking abilities.
- 1. Proficiency in Microsoft Office Suite (Excel, Word, and PowerPoint).
- 1. Good written and verbal communication skills.
- 1. Ability to collaborate effectively within multidisciplinary teams.
Preferred Skills
- 1. Experience with PK/PD modeling and simulation/statistical tools such as Phoenix WinNonlin, NONMEM, Monolix, R, SAS, or MATLAB.
- 1. Exposure to life sciences technology platforms, AI/ML applications, or data analytics projects.
- 1. Understanding of biostatistics, data visualization, and quantitative analysis techniques.
- 1. Familiarity with software validation, UAT, or product development activities.
- 1. Knowledge of GCP, ICH Guidelines, and regulatory requirements.
- 1. Experience working with cross-functional teams involving Science, Data Science, AI, and Software Engineering functions.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
📌 PK/PD Scientist/Sr. Scientist/Principal Scientist (PhD/MS) (Kochi)
🏢 Feathersoft Info Solutions
📍 Kochi