Stellenbeschreibung

CSL Behring – the global biotherapies provider driven by its promise to save lives and to improve the quality of life for people with rare and serious medical conditions.

For our location in Bern, we are looking for a

Director Clinical Pharmacology 

In this crucial and highly influential position within Clinical Pharmacology & Early Development (CPED; CMO Office) you are responsible for full clinical pharmacology (including pharmacometrics aspects of) programs for assigned global CSL projects and will be the key expert on all clinical pharmacology & pharmacometrics matters relating to assigned projects.

This includes leading a program’s clinical pharmacology & pharmacometrics strategy, ensuring coverage of all pharmacokinetic and modeling and simulation aspects, and the design of clinical pharmacology studies for a program. In addition, the role will lead interactions with regulatory authorities, writing of clinical pharmacology sections in the dossiers and answering questions in connection with submission procedures.

Main Responsibilities and Accountabilities:

• Lead development of the clinical pharmacology & pharmacometrics strategy for a portfolio program, working in conjunction with the Clinical Program Director and Therapeutic Area Lead.


• Where qualified, become the Early Clinical Development lead on a global project, leading all aspects of clinical team conduct and strategy (including chairing of the Clinical Expert Team, managing medical monitoring activities (MD qualification required), and being the project team’s Clinical Dev expert/representative) for a project at an early clinical development stage.


• Lead the design of clinical pharmacology studies or protocol sections as required throughout all stages of drug development and provide oversight for implementation of such studies together with all CPED and Clinical Development functions.


• Plan and implement all relevant PK-PD analyses, including non-compartmental analysis of PK data and appropriate PK-PD analysis including population PK, PK-PD modeling and simulation and meta-analysis as required.


• Lead the high quality review and interpretation of clinical pharmacology study results and oversees the presentation thereof in clinical study reports and related study documentation.


• Guide clinical pharmacology & pharmacometrics representation on clinical development matrix teams to ensure integration of the clinical pharmacology strategy within the global development plan.


• Implement the use of innovative analytical methods such as pharmacometrics/modeling & simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states in support of optimal study designs throughout an assigned clinical development program.


• Provide clinical pharmacology contributions to regulatory documents including Investigator Brochures, Labelling and those required for regulatory meetings and regulatory filings. Provides resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queries.


• Represents Clinical Pharmacology for market approval submissions to regulatory authorities, authority meetings and answers to all related authority questions.


• If required, provide support to Research and Translational Science and in the development of preclinical PK-PD knowledge required for early clinical development strategy, as well as utilizing Pharm-Tox data appropriately in the development of early clinical studies.


• Establish and maintain networks of external thought/opinion leaders in the clinical pharmacology field.


• Input to licensing projects as needed.


• Participate in the development of department specific SOPs and contribute to continuous process improvement.

Qualifications & Experience:

• PhD in Life Science


• At least 8 years’ experience in contributing to the clinical pharmacology aspects of clinical drug development


• Clinical pharmacology expert team leadership would be an asset


• Thorough understanding of general clinical pharmacology (including the design and conduct of clinical trials), interpretation of PK, PK/PD, population PK methodologies and related data interpretation, and the use of biomarkers in clinical development


• Proven technical ability in pharmacometrics methodology and application.


• Interpretation of basic, safety pharmacology and toxicology data


• In-depth knowledge of clinical pharmacology, pharmacokinetics and-dynamics


• Population pharmacokinetics and PK/PD modeling

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.