Associate Director, Project Representative​/Lab Manager

New Biological Entities Drug Metabolism And Pharmacokinetics (Nbe Dmpk) Lead

Work Your Magic with us! Start your next chapter and join EMD Serono.

Ready to explore, break barriers, and discover more? We know you've got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.

That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) Lead is a strategic, scientific and operational role in Research and Development (R&D). Our company is committed to bringing transformational medicines to patients, and you will collaborate in a matrixed environment with other passionate functional experts to deliver novel biotherapeutics. You will be responsible for managing the overall DMPK contributions to specific NBE projects, including antibody oligonucleotide conjugates (AOCs) and other biologics, from molecule design through preclinical and clinical phases, thus fulfilling internal and regulatory requirements.

You will define and refine the appropriate DMPK strategy for each molecule, including PK strategies to de-risk the clinical development plan, communicating bioanalytical strategies both preclinically and clinically, and immunogenicity risk assessments (IRAs), and for ensuring that studies are conducted on time and with the required quality. You will also be responsible for ensuring there is an appropriate M&S approach during the early discovery phases for assigned molecules, which could include working with experts to support integration of all existing knowledge on the molecule(s) and target(s) to acquire meaningful and research question-oriented M&S insights.

You should also be able to integrate the various bioanalytical and immunogenicity data to interpret drug disposition (pharmacokinetics and PK/PD) to guide engineering and optimization strategies of our biotherapeutics. In addition, an important requirement is having a broad experience in all aspects of bioanalytical sciences, particularly in PK and be able to provide technical oversight. You will be responsible for leading a small team of lab scientists, skilled in bioanalytical methods and relevant regulatory expectations.

The NBE DMPK Lead is a member of discovery project teams and/or global programs, depending on the phase of the project, and a scientific matter expert on teams, ensuring proper flow of information between the project, the function, and key stakeholders. You will ensure that studies within the NBE DMPK responsibility of the given project are conducted according to the agreed timelines and the required quality, and you will be accountable for DMPK contributions to international health authority submissions.

Who You Are

Minimum Qualifications:

• Ph.D. in Biochemistry, Biology, Chemistry, or related field.
• Experience with biological molecules (NBEs, ADCs, other novel modalities), in particular AOCs.
• Expertise in PK, bioanalytics, immunogenicity, and/or relevant sciences in AOC discovery/development.
• 5-7+ of professional experience in drug discovery/development, with excellent knowledge of drug discovery and development processes and workflows.
• Previous leadership experience, managing a team
• Fluent…