Head of Pharmacology

ProClinical is working with a clinical stage biopharmaceutical company that is seeking a Head of Pharmacology. This Pharmacology role will be based in Stuttgart on a permanent basis.

This job will serve as the subject matter expert in quantitative clinical pharmacology for multiple clinical stage bispecific antibody programs (Phase 1 to Phase 2/3 registrational studies).

Job Responsibilities:

• Collaborate with medical leads/MDs, clinical trial managers and biostatisticians to contribute to the clinical plans, study designs, protocol preparation, study execution, data review/analysis, report and regulatory document preparation
• Keep up-to-date with peer-reviewed publications to keep apprised of global regulatory updates, including updates to guidances in clinical pharmacology
• Provide expertise in developing and implementing clinical pharmacology plans and in the ongoing assessment of drug biodistribution and metabolism, dose-response and PK-response relationships, and population PK
• Work collaboratively with the clinical development teams and cross-functional teams to develop customer's clinical stage molecules. Collaborate with preclinical scientists to ensure a common understanding between the nonclinical and clinical PK data. Collaborate with preclinical scientists to ensure valid methods are in place for measuring drug concentrations and other biochemical markers in the clinic
• Provide oversight in the preparation, conduct, analysis and reporting of clinical pharmacology studies
• Provide oversight to the CRO staff and other vendors contributing to the execution of the clinical studies as it relates to protocol conduct and data collection and analysis for all clinical pharmacology studies and for all clinical pharmacology aspects of clinical studies
• Visit clinical study centers as needed to ensure training and compliance with clinical pharmacology aspects of studies
• Develop and update SOPs as needed
• Analyze pharmacokinetic and pharmacodynamic data from all clinical trials on an ongoing basis to advance the clinical programs
• Employ modelling and simulation to understand PK/PD relationships and translational data from clinical studies to guide dose selection and assess benefit-risk profiles.
• Provide PK/PD summaries and evaluations of clinical programs in the relevant sections of clinical and regulatory documents (e.g., clinical study protocols, investigator brochures, clinical sections of INDs, CTAs, DSURs) , and abstracts and manuscripts for publication
• Communicate with health authorities, IEC/IRB, and clinical experts/advisors as appropriate in support of the safety aspects of the clinical programs
• Represent clinical pharmacology during meetings with regulatory authorities

Skills and Requirements:

• PhD in pharmacokinetics or pharmacometrics, or Pharm D, or other relevant post-graduate degree
• 8 + Years of work experience in clinical pharmacology and pharmacometrics, primarily in the pharmaceutical industry
• Strong quantitative and analytical skills in PK/PD modelling, including the ability to integrate translational data from preclinical through clinical studies
• Understanding of database designs and outputs needed for pharmacometric statistical analysis and reporting
• Proven ability to manage multiple programs
• Through knowledge and understanding of GCP
• Experience supporting early and late-stage drug development programs, including thorough understanding of the pharmacometric requirements for regulatory submissions and experience filing IND, NDA, BLA and MAA applications within the pharmaceutical industry
• Experience working on biologics and oncology therapeutics a plus, but not required
• Experience in writing and presenting pharmacometric plans and results with internal and external stakeholders, including regulatory authorities
• Good knowledge of GCP and regulatory requirements
• Strong leadership competencies
• Strong interpersonal and communication skills, including ability to give oral presentations
• Strong writing skills
• Fluent in English; comfortable with writing clinical/scientific documents and conducting day to day meetings in English. Some knowledge of conversational German a plus

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Andreas Bartelt at a.bartelt@proclinical.com or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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