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Join to apply for the NBE ADME&DMPK Principal Scientist role at Almirall
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Join to apply for the NBE ADME&DMPK Principal Scientist role at Almirall
* 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.
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 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, perform, direct, or outsource 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, 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 that PK, PK/PD, dose predictions, or other related non-clinical or clinical PK deliverables are undertaken to best practice standards 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 for regulatory documents, such as INDs, CTAs, MAA, or 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 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/or related sciences required in both preclinical and clinical stages of drug discovery/development.
* Excellent understanding of translational medicine aspects to connect preclinical/clinical DMPK, including 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 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 is highly valued.
Competencies
* Teamwork and personal leadership.
* Ability to work in a matrix environment, multi-task, meet deadlines, and deal with evolving priorities.
* Strategic thinking with leadership skills and the ability to work collaboratively across teams and disciplines.
* Building and maintaining professional networks to support collaborative efforts.
* Fluent in both oral and written English for effective communication and documentation.
* Excellent intercultural understanding.
Values
* Care: listening & empathizing, valuing diverse perspectives & backgrounds, and helping each other succeed.
* Courage: challenging the status quo, taking ownership, and learning from successes & failures.
* Innovation: putting patients and customers at the center, creating novel solutions, and empowering entrepreneurial mindsets.
* Simplicity: acting decisively, avoiding over-analysis, understanding why before acting, and maintaining agility and simplicity.
Why work with Almirall?
We are a people-centric company where employees thrive, patients and customers are at the heart of decisions, and our focus and agility deliver greater impact. We have been certified as Top Employer Spain for 17 years and Top Employer Germany for the first time, reflecting our commitment to a supportive work environment that fosters growth and development.
Our purpose is to Transform the patients' world by helping them realize their hopes & dreams for a healthy life.
Our values include Care, Courage, Innovation, and Simplicity, guiding our actions and decisions.
At Almirall, it’s all about people!
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