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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 information flow between the project, the function, and key stakeholders.
* Participate in, oversee, or outsource studies to enhance knowledge of ADME / DMPK in non-clinical and clinical development.
* Manage bioanalytical needs (e.g., PK, ADA, Nab assays) supporting non-GLP or GLP ADME / DMPK studies across drug development, ensuring compliance with 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 MIDD approaches in collaboration with non-clinical and clinical teams.
* Ensure PK, PK/PD, dose predictions, and other related deliverables meet best practice standards for study design and regulatory submissions.
* Provide high-quality data and presentations internally and to partners for regular project updates.
* Author comprehensive reports, including support for regulatory documents such as INDs, CTAs, MAA, or BLA filings.
* Evaluate external assets for clinical and nonclinical ADME / DMPK and communicate findings and recommendations clearly to stakeholders.
* Maintain current 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 modeling & simulation concepts.
* Deep knowledge of regulatory requirements and guidelines for NBE ADME / DMPK, with the ability to de-risk drug submissions by understanding regulatory expectations.
Experience
Over 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, multitask, meet deadlines, and adapt to changing priorities.
* Strategic thinking with leadership capabilities and collaborative work 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, empathy, 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 patients and customers, creating novel solutions, and fostering entrepreneurial mindsets.
* Simplicity: acting decisively, understanding reasons before acting, being agile, and keeping things simple.
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