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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.
* Be responsible for bioanalytical needs (e.g., PK, ADA, and Nab assays) supporting non-GLP or GLP ADME / DMPK studies across drug development, ensuring adherence to global regulatory standards (e.g., FDA, EMA).
* Integrate 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 PK, PK/PD, dose predictions, and other related non-clinical or clinical PK deliverables meet best practice standards for study design and regulatory submissions.
* Provide high-quality data and presentations internally and to potential partners, ensuring regular progress updates on ongoing projects.
* Author high-quality reports, including support for regulatory documents such as INDs, CTAs, and MAA or BLA filings when needed.
* Evaluate external assets for clinical and non-clinical ADME / DMPK and communicate 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 stages.
* Excellent understanding of translational medicine, connecting preclinical / clinical DMPK, including modeling & simulation concepts.
* Comprehensive knowledge of regulatory requirements and guidelines related to NBE ADME / DMPK, with a strong capacity to de-risk drug submissions by understanding regulatory agency expectations.
Experience
7+ years of industry experience in ADME / DMPK / Bioanalysis of biological molecules such as NBEs, ADCs, or other novel modalities.
Experience with mRNA LNPs modality will be highly valued.
* Teamwork and personal leadership skills.
* Ability to work in a matrix environment, multitask, meet deadlines, and handle evolving priorities.
* Strategic thinking with leadership skills and collaborative working across teams and disciplines.
* Ability to build and maintain professional networks for collaboration.
* Fluent in both oral and written English for effective communication and documentation.
Values
* Care: We listen, empathize, value diverse perspectives, and support each other's success.
* Courage: We challenge the status quo, take ownership, and learn from successes and failures.
* Innovation: We prioritize patients and customers, create novel solutions, and empower entrepreneurial mindsets.
* Simplicity: We act decisively, avoid over-analysis, understand why before acting, and remain agile and simple.
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