ADME & DMPK Principal Scientist

Mission

• Be a member of R&D project teams to provide expert ADME & DMPK guidance across the non-clinical and clinical development of NBEs, including new drug modalities such as mRNA LNPs,  in a multidisciplinary environment.
• Drive ADME & DMPK profiling, bioanalysis, PK/PD, human dose predictions,  M&S or  other related deliverables, to advance biologic drugs  through early and late development up to health authority submissions.

Tasks and Responsabilities

• 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.
• Participation, performance, direction or outsourcing of studies to improve the knowledge of ADME/DMPK across non-clinical & clinical development.
• Responsible for the bioanalytical needs (e.g. PK, ADA and Nab assays) to support non-GLP or GLP ADME/DMPK studies across drug development, as well as ensure adherence to global regulatory standards (e.g., FDA, EMA).
• Integrate the 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 that PK, PK/PD, dose predictions or other related non-clinical or clinical PK deliverables are undertaken to best practice standard for study design and regulatory submissions.
• Provide high-quality data and presentations, both internally and to potential partners, to ensure regular progress updates on ongoing projects.
• Author high quality reports, including support to regulatory documents, such as  INDs, CTAs, MAA of BLA filings when needed.
• Evaluate external assets for clinical and nonclinical ADME/DMPK and clearly communicate findings and recommendations to stakeholders.
• Maintain an up-to-date knowledge of the relevant scientific literature as well as regulatory guidance and best practice.

Education

• MSc/PhD in Pharmacy, Chemistry, Biochemistry, Biology, biomedicine or related Life Sciences

Specific Knowledge

• Broad experience in the bioanalytical science for biotherapeutics.
• Expertise in immunogenicity testing  and/or related sciences required in both the preclinical and clinical stages of drug discovery/development.
• Excellent understanding of translational medicine aspects to connect preclinical/Clinical DMPK, which includes adequate knowledge of  Modelling&Simulation concepts.
• Comprehensive knowledge of regulatory requirements and guidelines related to NBE ADME/DMPK and strong capacity to de-risk drug submissions thought a deep understanding of the expectations of regulatory agencies.

Experience

• 7+ years of industry experience in the field of ADME/DMPK/Bioanalysis of biological molecules, such as NBEs, ADC, or other novel modalities.

• Experience with mRNA LNPs modality will be highly valued.

Competencies

• Teamwork and personal leadership.
• Ability to work in a matrix environment, multi-task, meet deadlines and deal with evolving priorities.
• Strategic thinker with leadership skills and the ability to work collaboratively across various teams and disciplines.
• Capable of building and maintaining professional networks to support collaborative efforts.
• Fluent in both oral and written English, essential for effective communication and documentation.
• Excellent inter-cultural understanding.

Values

• Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
• Courage: we challenge the status quo, we take full ownership and we learn from our success & failures
• Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets. 
• Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.