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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 the proper flow of information between the project, the function, and key stakeholders is in place.
* Participate in, perform, direct, or outsource studies to improve knowledge of ADME / DMPK across non-clinical & clinical development.
* Manage bioanalytical needs (e.g., PK, ADA, and Nab assays) to support 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.
* Collaborate with non-clinical and clinical departments to design pre-clinical and clinical translational strategies and MIDD approaches.
* Ensure PK, PK / PD, dose predictions, or other related non-clinical or clinical PK deliverables are conducted according to best practices for study design and regulatory submissions.
* Provide high-quality data and presentations internally and to potential partners, with regular progress updates on ongoing projects.
* Author high-quality reports, including support for regulatory documents such as INDs, CTAs, and BLA filings when needed.
* Evaluate external assets for clinical and nonclinical ADME / DMPK, and communicate findings and recommendations 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 stages of drug discovery / development.
* Strong understanding of translational medicine connecting preclinical / clinical DMPK, including modeling and simulation concepts.
* Comprehensive knowledge of regulatory requirements and guidelines related to NBE ADME / DMPK, with the ability 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.
Experience with mRNA LNPs modality will be highly valued.
* Strong teamwork and leadership skills.
* Ability to work in a matrix environment, multitask, meet deadlines, and adapt to evolving priorities.
* Strategic thinking with leadership capabilities 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: 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: focusing on the patient and customer, creating novel solutions, and fostering entrepreneurial mindsets.
* Simplicity: acting decisively, understanding why before acting, and maintaining agility and simplicity.
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