About the Role
We are seeking a highly skilled and experienced ADME/DMPK Expert to join our team at Almirall-Hermal GmbH. As an ADME/DMPK Expert, you will represent our DMPK function in cross-functional teams and collaborate with external partners to deliver data and support informed decision-making aligned with project goals.
Key Responsibilities
* Ensure effective communication between projects, functions, and key stakeholders
* Participate in, oversee, or outsource studies to enhance knowledge of ADME/DMPK in non-clinical and clinical development
* Manage bioanalytical needs for non-GLP or GLP ADME/DMPK studies throughout drug development, ensuring compliance with global regulatory standards
* Evaluate external assets for clinical and nonclinical ADME/DMPK, communicating findings and recommendations clearly to stakeholders
Requirements
* MSc/PhD in Pharmacy, Chemistry, Biochemistry, Biology, Biomedicine, or related Life Sciences
* 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
* In-depth knowledge of regulatory requirements and guidelines for NBE ADME/DMPK, with the ability to de-risk drug submissions by understanding regulatory expectations
* At least 7 years of industry experience in ADME/DMPK/Bioanalysis of biological molecules such as NBEs, ADCs, or other novel modalities
Desirable Qualifications
* Experience with mRNA LNPs modality
* Strong teamwork and leadership skills
* Ability to operate in a matrix environment, multitask, meet deadlines, and adapt to changing priorities
* Strategic thinking with leadership qualities and collaborative skills across disciplines
* Ability to build and maintain professional networks for collaborative efforts
We Value
* Care: We listen, empathize, value diverse perspectives, and support each other's success
* Courage: We challenge the status quo, take ownership, and learn from successes and failures
* Innovation: We focus on patients and customers, create novel solutions, and foster entrepreneurial mindsets
* Simplicity: We act decisively, understand the reasons behind actions, and stay agile and straightforward