**Date**:18 Feb 2025
**Location**: SFEL - R&D; SANT FELIU DE LLOBR, ES, ES - Spain
**Company**:Almirall
**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.
- 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 general 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.