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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 proper flow of information between the project, the function, and key stakeholders.
* Participate in, perform, direct, or outsource studies to enhance knowledge of ADME / DMPK across non-clinical and clinical development.
* Manage bioanalytical needs (e.g., PK, ADA, Nab assays) to support non-GLP or GLP ADME / DMPK studies throughout drug development, ensuring adherence to global regulatory standards (e.g., FDA, EMA).
* Integrate bioanalytical and immunogenicity data to interpret PK.
* Contribute to the design of pre-clinical and clinical translational strategies and Model-Informed Drug Development (MIDD) approaches in collaboration with non-clinical and clinical departments.
* Ensure PK, PK/PD, dose predictions, or other related deliverables are conducted according to best practices for study design and regulatory submissions.
* Provide high-quality data and presentations internally and to potential partners, ensuring regular updates on ongoing projects.
* Author high-quality reports, including support for regulatory documents such as INDs, CTAs, MAA, or BLA filings when needed.
* Evaluate external assets for clinical and nonclinical 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 both preclinical and clinical stages of drug discovery and development.
* Excellent understanding of translational medicine, connecting preclinical and clinical DMPK, including knowledge of Modelling & Simulation concepts.
* Comprehensive knowledge of regulatory requirements and guidelines related to NBE ADME / DMPK, with the capacity to de-risk drug submissions through a deep understanding of 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.
* Ability to work in a matrix environment, multi-task, meet deadlines, and adapt to evolving priorities.
* Strategic thinker with leadership skills and the ability to collaborate across teams and disciplines.
* Ability to build and maintain professional networks to support collaboration.
* Fluent in both oral and written English for effective communication and documentation.
Values
* Care: listening, empathizing, valuing diverse perspectives, and supporting each other's success.
* Courage: challenging the status quo, taking ownership, and learning from successes and failures.
* Innovation: centering on patient and customer needs, creating novel solutions, and fostering entrepreneurial mindsets.
* Simplicity: acting decisively, understanding reasons before acting, and maintaining agility and simplicity.
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