Principle Scientist, Translational Quantitative Pharmacology

Location

Bangalore | India

Job description

• To be able to independently develop quantitative mechanism-based PK/PD models that will inform compound progression decisions from lead optimization to clinical proof of concept and beyond for the immunology and oncology pipelines, both for large and small molecule pharmaceuticals.
• The selected candidate will have responsibilities for performing human PK predictions and quantitative DDI predictions, the design and analysis of pre-clinical PK/PD data to support lead optimization and prioritization, and translational PK/PD analyses to support FIM dose estimates for both small/large molecules and ADCs.
• The candidate will work to develop models or use commercially available software tools to understand and quantify toxicological signals such as cardiovascular, hepatic, renal, dermal etc to determine the therapeutic index and help guide project decisions
• To be able to interact with various project team members in a clear and timely manner, understanding the functions of other team members and being able to explain and educate modeling efforts and results to team members from various backgrounds
• The successful candidate will work in a dynamic team with frequent interactions, both within the team and associated functions, and is responsible for the development and implementation of innovative modeling and simulation platforms/strategy that ensure that the right drug is administered to the right patient at the right dose/regimen.
• The selected candidate will work in close partnership with Pharmacology, Safety, Clinical Sciences, Biostatics and Regulatory. As a member of project teams and sub-teams, the candidate will represent QP and present analysis outcomes to cross-functional teams, at department meetings, project review committees and conferences.
• The candidate will contribute to the preparation and presentation of both internal and external documentation (e.g. Investigators Brochure, IND, CTD) and product strategy

Interfaces with other Departments/Functions:

• Oncology and Immunology Research Units
• Clinical Pharmacology (CP)
• Biostatistics
• Safety sciences (Toxicology)
• DMPK
• Epidemiology/Biomarkers
• Pharmacometrics
• Bioinformatics
• Project Teams (CP, Biomarkers and GPT)

External Interfaces:

• Represent company/ organization in consortia (e.g. IQ working groups) and academic research partnerships.
• Represent function and department in interactions with contractors
• Present and publish work in relevant journals and MIDD related conferences.

Who you are:

EDUCATION/LANGUAGES

• A minimum of 3 years in industry and/or academia in a relevant background
• A PhD in Pharmacokinetics, Pharmaceutical Sciences, Biomedical/Chemical Engineering, Applied Mathematics, Statistics or a related discipline with a proven track record of applying modeling and simulation approaches to biological problems
• Fluency in English.

PROFESSIONAL SKILLS & EXPERIENCE

• In-depth hands-on experience with modeling software (such as; MatLab, R, Phoenix/WinNonlin, NONMEM, Monolix etc)
• Experience with DDI predictions using appropriate static and dynamic approaches (SimCyp) are desirable
• Experience with toxicological predictions using tools such as DILI Sym/RenaSym for hepatic and renal toxicity respectively is highly desirable
• Openness to fresh ideas and new perspectives to be gathered from working with people from diverse backgrounds and cultures.
• Flexibility and keen pursuit of innovation throughout all phases of the drug discovery and development process
• A desire to develop and grow by way of taking responsibility and engaging in additional tasks and operations.
• Ability to work independently and deliver results in a timely manner
• Publications in conference proceedings and peer-reviewed journals are encouraged
• Excellent communication skills with the ability to translate and summarize outcomes of modeling and simulation analysis as relevant for discovery and development projects

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