NBE DMPK Lead (all genders)

New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) Lead is a strategic, scientific, and operational role in Research and Development (R&D).

Healthcare 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 biotherapeutic projects, including antibody drug conjugates (ADCs) and other biologics, from molecule design through Life Cycle Management (LCM), thus fulfilling internal and regulatory requirements.

An important requirement is having a broad experience in leading projects, a proven track record in DMPK, and expertise with modelling and simulation, as well as a modality agnostic, expert understanding of the different approaches related to PK.

As required per project, you will define and refine the appropriate strategy for each molecule, including PK strategies to de-risk the clinical development plan, bioanalytical strategies both preclinically and clinically, M&S strategies, and for ensuring that studies are conducted on time and with the required quality.

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.

Understanding bioanalytical sciences, particularly in immunogenicity risk assessments and testing strategies during discovery, development, and approval / post-approval activities, is important.

The NBE DMPK Lead is a member of the Discovery or Global Project Team, depending on the phase of the project, or due diligence teams as needed, and a scientific matter expert on teams, representing the NBE DMPK function on these teams and ensuring that the proper flow of information between the project, the function, and key stakeholders is in place.

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 contributions to international health authority submissions.

The role will be based in Italy or Germany. Who you are : Ph.D. in Pharmacokinetics / Pharmacodynamics, Pharmacometrics or a related field.

Experience in PK / PD or PBPK modeling preferred (incl. knowledge in relevant software, e.g. NONMEM, R, Phoenix WinNonLin).

Several years of professional experience in drug discovery and development (>

7 years), with excellent knowledge of discovery and development processes and workflows.Solid understanding of translational sciences, regulatory requirements, and work packages (nonclinical and clinical).

Experience with biological drug candidates is a plus.Expertise in immunogenicity, DMPK, bioanalytical sciences, and / or related sciences, in both the preclinical and clinical stages of drug discovery / development, is preferred.

General knowledge of disease areas (e.g. Immunology, Oncology, etc.), and in-depth understanding of biology and pharmacology.

Excellent organizational skills and communication skills; fluent spoken and written English, German or Italian is a plus.

Excellent inter-cultural understanding.Strong mature leadership and influencing skills.