Leiter Biotechnologie - Mainz, Deutschland - KHR Biotec GmbH

Beschreibung

Leiter Biotechnologie / Pharmakologe / Toxicologist as Director of Pre-Clinical Pharmacology (m/w/d):

Director of Pre-Clinical Pharmacology and Toxicology (M/F/d):
KHR Biotec GmbH is a pharmaceutical biotech company and a spin-off of the Johannes Gutenberg University Mainz. Our goal is to develop novel therapeutics by elucidating the complex signaling mechanisms underlying major diseases. We aim to develop novel therapeutics related to precision oncology.

We are embedded in the well-structured research laboratories of the University Medicine Mainz with the intention to expand our activities in the coming years.

Our international research team is led by experienced and respected experts with interdisciplinary expertise in basic and translational medicine.


Key Responsibilities:

Provide expert scientific leadership in the areas of pre-clinical pharmacology, DMPK and toxicology to pre-clinical discovery project teams, and ensure that pre-clinical data packages support the clinical development plan, including:

• CRO Management
• accountable for the delivery of critical project data through a network of external study providers. In collaboration with project teams, select CROs and participate in study design, troubleshooting, data analysis and interpretation, QC/audit and oversight of study reports.
• Design, conduct and analysis of DMPK studies to elucidate metabolic fate, drugdrug and transporter interactions.
• Application of allometric scaling and dose prediction models for oral and parenteral drugs.
• Assist the project team in developing clinical PK and PK/PD/pharmacology plans
• Translational and Biomarker studies facilitate project transitions to Clinical Development in close collaboration with discovery, translational and clinical scientists.
• Regulatory manage the preparation and/or presentation of preclinical sections of external documents (e.g. Investigator's Brochure, IND/CTA, PIP, CTD, etc.).

Job Requirements:

• 10+ years of experience in the pharma/ biotechnology industry, with demonstrated small molecule drug discovery experience and a track record of advancing multiple novel therapeutic agents from discovery into preclinical and subsequent clinical development as project team leader or member
• Strong background in Translational oncology
• Track record of scientific leadership excellence
• Experience in successfully selecting and managing CROs to provide high quality, timely and onbudget studies
• Additional experience with preclinical animal models of genetic diseases strongly preferred
• German and English language skills, both written and spoken

We offer:

• A permanent employment contract in an ownermanaged company
• Additional operational benefits
• Challenging field of activity in a strongly growing company
• Creative freedom
• Family friendly conditions
• A cooperative team and a good working atmosphere
• Continuous education and training
• Flexible and remote working options
• Competitive package

Have we sparked your interest?:

We look forward to hearing from you.

KHR Biotec GmbH
Obere Zahlbacher Straße 63, 55131 Mainz