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Mission 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.
* Participate in, oversee, or outsource studies to improve knowledge of ADME / DMPK across non-clinical & clinical development.
* Manage bioanalytical needs (e.g., PK, ADA, Nab assays) supporting non-GLP or GLP ADME / DMPK studies, ensuring compliance with global regulatory standards (e.g., FDA, EMA).
* Integrate bioanalytical and immunogenicity data to interpret PK.
* Contribute to the design of preclinical and clinical translational strategies and MIDD approaches in collaboration with non-clinical and clinical departments.
* Ensure PK, PK/PD, dose predictions, or related non-clinical/clinical PK deliverables meet best practice standards for study design and regulatory submissions.
* Provide high-quality data and presentations internally and to partners, ensuring regular updates on project progress.
* Author high-quality reports, including support for regulatory documents such as INDs, CTAs, MAAs, or BLA filings.
* Evaluate external assets for clinical and nonclinical ADME / DMPK, communicating findings and recommendations clearly to stakeholders.
* Maintain up-to-date knowledge of relevant scientific literature, regulatory guidance, and best practices.
Education
* MSc / PhD in Pharmacy, Chemistry, Biochemistry, Biology, Biomedicine, or related Life Sciences.
Specific Knowledge
* Broad experience in bioanalytical science for biotherapeutics.
* Expertise in immunogenicity testing and related sciences in preclinical and clinical drug discovery/development.
* Strong understanding of translational medicine connecting preclinical and clinical DMPK, including Modelling & Simulation concepts.
* Comprehensive knowledge of regulatory requirements and guidelines related to NBE ADME / DMPK, with the capacity to de-risk drug submissions by understanding regulatory expectations.
Experience
7+ years of industry experience in ADME / DMPK / Bioanalysis of biological molecules such as NBEs, ADCs, or other novel modalities.
Valued Experience
* Experience with mRNA LNPs modality is highly valued.
* Strong teamwork and leadership skills.
* Ability to work in a matrix environment, multi-task, meet deadlines, and adapt to evolving priorities.
* Strategic thinking with leadership qualities and collaborative working across disciplines.
* Ability to build and maintain professional networks for collaboration.
* Fluent in oral and written English for effective communication and documentation.
Values
* Care: Listening, empathizing, valuing diverse perspectives, and helping others succeed.
* Courage: Challenging the status quo, taking ownership, and learning from successes and failures.
* Innovation: Centering on the patient and customer, creating novel solutions, and fostering entrepreneurial mindsets.
* Simplicity: Acting decisively, understanding reasons before acting, being agile, and keeping things simple.
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