Associate Director Quantitative Data Modeling
- Ability to formulate drug development questions and develop modeling and simulation strategies for optimizing model-informed drug development in all stages of development, ranging from first in human dosing through life cycle management.
- Conduct with minimal supervision model-based analyses such as population pharmacokinetics (PPK), PK/PD, exposure response, model-based meta-analysis, clinical trial simulations and disease progression modeling to drive internal pipeline forward.
- Conduct innovative quantitative methodologies such as data analytics, machine learning and mechanistic modeling as needed.
- Strong quantitative skills including but not limited to mathematics, statistics, data science, AI/ML, etc.
- Deep and extensive experience with advanced population modeling approaches (e.g. PPK, PKPD, etc. ) and complex methodologies such data analytic, AI/ML and mechanistic modeling.
- Proficiency in conducting model-based analyses using standard pharmacometrics software (e.g., NONMEM, R, Monolix, etc.)
- Proficiency in integrating and analyzing internal and external data to support decision making and to generate scientific insights.
- Strong written and verbal communication skills, interdisciplinary collaboration, problem scoping and planning.
- Good knowledge of industry best practices, global regulatory, processes, standards of drug development.
- Serve as M&S representative for clinical development projects.
- Act as a subject matter expert addressing technical and theoretical issues in the M&S area.
- Be able to operate in a multicultural environment and participate in international teams.
- Prepare and issue stand-alone M&S reports with minimal review.
- Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA
- Prepare abstracts, posters and manuscripts for external presentation and/or publication.
- Present at external scientific meetings as appropriate
- Identify skill-sets necessary to advance career development.
- Ensure that all assigned project activities are performed in compliance with current departmental SOP’s, guidelines, industry best practices and regulatory guidelines, and are conducted following acceptable scientific rationale.
- Ph.D. with or without post-doctoral experience in pharmacometrics, biopharmaceutics, pharmaceutical sciences, mathematics, statistics, data science, computational biology, chemical/biomedical engineering, system pharmacology, computer science or closely related discipline plus at least 5 years of industrial experience with a record of increasing responsibility and independence
- Technical expertise in several of the following areas ranging from classic translational and population PK modeling, PK/PD modeling, exposure-response modeling, clinical trial simulation, drug-disease modeling, PBPK modeling, to advanced complex methodologies such as data analytics, machine learning and mechanistic modeling.
- Strong background in different M&S software such as NONMEM, R, Monolix, Phoenix NLME, PUMAS, Matlab, PKsim, SimCYP, SAS, Python, C/C++, Julia
- Excellent oral and written communication skills and strong problem-solving skills
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
#LI-SA
#LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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