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
  • Standort: Stuttgart

Pro Clinical

Bitte beziehen Sie sich bei Ihrer Bewerbung auf Let's Work.