(Senior) Principal Clinical Pharmacology Lead

vor 4 Monaten


Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

This position can be filled in Ingelheim or Biberach

**Tasks & responsibilities as Principal Clinical Pharmacologist**:
- As Principal Clinical Pharmacology Lead, you will represent Clinical Pharmacology (Clin. Pharm.) in BI project teams as well as in internal or external initiatives or working groups.- You will provide input into clinical development plans, clinical study protocols and reports, Investigator’s Brochures and the ClinPharm section of INDs, CTA’s, NDAs/BLAs or respective label text.-
- You will be accountable for all ClinPharm aspects of a compound in early and late-stage clinical drug development towards regulatory authorities worldwide in one of Boehringer Ingelheim’s core therapeutic areas of Oncology, Cardio-Renal & Metabolism, CNS or Retinal Health.-
- You will be part of medical and R&D development teams throughout the development.***Additional tasks & responsibilities as Senior Principal Clinical Pharmacologist**:
- As Senior Principal Clinical Pharmacology Lead you will additionally take a leading role in implementing and promoting innovative methodologies and approaches, and provide training and expert advice to junior colleagues and interfaces.

***Requirements as Principal Clinical Pharmacologist**:

- Ph.D. in Pharmaceutical Sciences or other life sciences with
- Advanced knowledge of Clinical Pharmacology aspects in drug development such as Pharmacokinetics & Pharmacodynamics (PK/PD) principles, Biopharmaceutics, and Clinical Pharmacology aspects in patient trials, incl. special populations such as pediatrics
- Thorough understanding of pre-clinical and clinical drug metabolism, PK/PD, drug-drug/food interactions; working knowledge in pharmacokinetic software programs incl. understanding of modeling tools e.g. PBPK
- Thorough knowledge on Clinical Pharmacology related guidelines from the main regulatory agencies
- Basic knowledge in biomarkers, pharmacogenomics, and biostatistics
- Excellent oral and written communication, negotiation, and presentation skills

***Additional requirements as Senior Principal Clinical Pharmacologist**:

- Distinct social and leadership skills
- Great sense of responsibility and interest in interdisciplinary work
- Demonstrated comprehensive knowledge of the drug development process

***Ready to contact us?**:
Please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330.

Recruitment process:
Step 2: Virtual meeting until Mid-September
Step 3: On-site interviews until end of September



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