Senior Principal Scientist - PK/PD Modelling
Ablynx, a Sanofi company, is a biopharmaceutical company dedicated to creating new antibody-based medicines called NANOBODY ® therapeutics which are making a real difference to society. Ablynx currently has over 400 people working on the development of NANOBODY ® therapeutics for the treatment of a wide range of diseases, including inflammation, immuno-oncology and rare diseases.
About the Opportunity
As an experienced PK/PD Modelling Scientist you will provide pharmacokinetic/pharmacodynamic expertise and strategies for lean drug development to project teams. You will develop and review protocols, analysis plans, study reports, ensure PK/PD and/or ER analyses and ensuing modeling and simulation activities. In this function you will contribute to preparation of integrated regulatory documents, interact with health authorities, when needed, and represent the Company in external meetings/conferences.
This position will allow you to follow the complete cycle of M&S activities: the elaboration of M&S strategies for efficient project decision-making, the implementation of the technical execution of the planned activities and presentation/discussion/validation of the latter with Health Authorities.
As a PK/PD representative, you will closely interact with modeling groups in other lines (DMPK, TDM) with experts in bioassays, CMC, therapeutic areas and translational sciences.
- develop the M&S strategy and contribute to the clinical development plan for clinical development projects and identify opportunities where model-informed drug development (MIDD) can advance the understanding of pharmacological activity, efficacy and safety.
- be responsible for the planning and execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta-analysis as well as PBPK to support internal decision making and successful approval.
- ensure the timely delivery of M&S documents (e.g., dataset specification, analysis plans, and reports) and documents where M&S function is co-author (e.g., clinical development plan, pediatric investigational plan, submission documents).
- continuously evaluate and implement novel M&S methods and approaches and may provide support and/or development of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes.
Requirements & Qualifications
- PhD, MD or Master’s Degree in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with first experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia, preferred with at least 5 years of R&D experience in industry, with focus on clinical or translational research.
- Proficiency in applying PMx software (e.g., NONMEM, R, SAS, PBPK software, …. or equivalent).
- Broad knowledge and understanding of pharmacological processes and mindset in translational research and bridging strategies.
- Knowledge of regulatory requirements and experience in interactions with regulatory authorities.
Your CV should be in English and include a paragraph specifying your technical expertise.
Inspire your Journey.
What Sanofi can offer you
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
- An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
- An individual and well-structured introduction and training when you onboard.
- You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
- As a globally successful and constantly growing company, Sanofi provides international career paths as well.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
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