* Be a member of R&D project teams to provide expert ADME & DMPK guidance across the non-clinical and clinical development of NBEs, including new drug modalities such as mRNA LNPs, in a multidisciplinary environment.
* Drive ADME & DMPK profiling, bioanalysis, PK / PD, human dose predictions, M&S or other related deliverables, to advance biologic drugs through early and late development up to health authority submissions.
Tasks and Responsibilities
* Represent the DMPK function in cross-functional teams or in collaboration with external partners, to deliver data and drive informed decision-making aligned with project goals. Ensure that the proper flow of information between the project, the function, and key stakeholders is in place.
* Participation, performance, direction or outsourcing of studies to improve the knowledge of ADME / DMPK across non-clinical & clinical development.
* Responsible for the bioanalytical needs (e.g. PK, ADA and Nab assays) to support non-GLP or GLP ADME / DMPK studies across drug development, as well as ensure adherence to global regulatory standards (e.g., FDA, EMA).
* Integrate the various bioanalytical and immunogenicity data to interpret PK.
* Contribute to the design of pre-clinical and clinical translational strategies and MIDD approaches in collaboration with non-clinical and Clinical departments.
* Ensure that PK, PK / PD, dose predictions or other related non-clinical or clinical PK deliverables are undertaken to best practice standard for study design and regulatory submissions.
* Provide high-quality data and presentations, both internally and to potential partners, to ensure regular progress updates on ongoing projects.
* Author high quality reports, including support to regulatory documents, such as INDs, CTAs, MAA of BLA filings when needed.
* Evaluate external assets for clinical and nonclinical ADME / DMPK and clearly communicate findings and recommendations to stakeholders.
* Maintain an up-to-date knowledge of the relevant scientific literature as well as regulatory guidance and best practice.
Education
* MSc / PhD in Pharmacy, Chemistry, Biochemistry, Biology, biomedicine or related Life Sciences.
Specific Knowledge
* Broad experience in the bioanalytical science for biotherapeutics.
* Expertise in immunogenicity testing and / or related sciences required in both the preclinical and clinical stages of drug discovery / development.
* Excellent understanding of translational medicine aspects to connect preclinical / clinical DMPK, which includes adequate knowledge of Modelling & Simulation concepts.
* Comprehensive knowledge of regulatory requirements and guidelines related to NBE ADME / DMPK and strong capacity to de-risk drug submissions through a deep understanding of the expectations of regulatory agencies.
Experience
7+ years of industry experience in the field of ADME / DMPK / Bioanalysis of biological molecules, such as NBEs, ADC, or other novel modalities.
Experience with mRNA LNPs modality will be highly valued.
* Teamwork and personal leadership.
* Ability to work in a matrix environment, multi-task, meet deadlines and deal with evolving priorities.
* Strategic thinker with leadership skills and the ability to work collaboratively across various teams and disciplines.
* Capable of building and maintaining professional networks to support collaborative efforts.
* Fluent in both oral and written English, essential for effective communication and documentation.
Values
* Care : we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
* Courage : we challenge the status quo, we take full ownership and we learn from our success & failures.
* Innovation : we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
* Simplicity : we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
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