(Senior) Principal Clinical Pharmacology Lead

Hiring By - Biostaffic

 BioPharma

Germany

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
THE POSITION
As Clinical Pharmacology Lead you act in global development teams with a responsibility for the Clinical Pharmacology development package.
You work in a department (Translational Medicine & Clinical Pharmacology) bridging the path from early research to submission interacting with multiple functional areas within BI. You have the choice to work at the Ingelheim site in close proximity to Frankfurt am Main or the Biberach site in the southern part of Germany close to the Alpes and Lake Constance.
This position can be filled in Ingelheim or Biberach
Tasks & responsibilities as Principal Clinical Pharmacology Lead
  • 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 expertise to the overall pre-clinical and clinical drug development of new drug candidates, in particular the design and oversight over the whole clinical pharmacology development including support of formulation development/biopharmaceutical aspects.
  • 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 Pharmacology Lead
  • 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 Pharmacology Lead
  • 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 Pharmacology Lead
  • 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.
Discover our Biberach site: xplorebiberach.com

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Germany

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 17, 2024
Company Overview
Boehringer Ingelheim
Boehringer Ingelheim

Current Openings: 0

Seit mehr als 135 Jahren erforscht, entwickelt und produziert Boehringer Ingelheim neue Medikamente mit hohem therapeutischem Nutzen für Mensch und Tier. Als Pharmaunternehmen in Familienbesitz planen wir langfristig und investieren daher besonders in die Forschung und Entwicklung. Wir sind stolz, so einige der größten Gesundheitsprobleme unserer Zeit angehen zu können. Unsere Vision „Werte schaffen durch Innovation“ hat unsere Zusammenarbeit seit jeher geprägt und ist für uns Anspruch und Antrieb zugleich. Mit Hauptsitz in Ingelheim, Deutschland, beschäftigt Boehringer Ingelheim weltweit insgesamt rund 53.000 Mitarbeiter. Weitere Informationen zu Boehringer Ingelheim finden Sie unter www.boehringer-ingelheim.de
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