Dmpk & Clinical Pharmacology F/m

vor 1 Tag

Lausanne, Schweiz Lysalto AG Vollzeit

**DMPK & Clinical Pharmacology F/M**

**COMPANY**

ALTOGEN is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices.

With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.

We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.

To strengthen our team in **Switzerland**, we are looking for a **DMPK & Clinical Pharmacology Expert** (M/F) to start asap.

**ABOUT THE JOB**:
In depth DMPK and Clinical Pharmacology knowledge across in infectious diseases areas to provide strategic advice and design ideas to allow rational drug development of small molecules.
- Preparing of/contributing to first in human needs and best practice study design and preparation of global clinical pharmacology strategy and development plans
- Preparing clinical risk assessments based on animal safety data and calculation of human safe starting dose
- In depth knowledge of Designing, Planning, Conducting, Analysing (data analysis and bioanalysis) and Interpreting in vivo and in vitro ADME, PK, toxicokinetic and PK/PD studies
- Bioanalysis requirements to support regulatory standard preclinical and clinical sample analysis
- Managing (scientific and planning) of studies conducted at external CROs
- Authoring pre-clinical DMPK and clinical aspects of IND’s and CTA’s, Regulatory Briefing Documents, Investigational Brochures, Investigational Medicinal Product Dossiers (IMPD) and dossier updates for established products, Common Technical Documents (CTD), IND annual reports, Type-II variations, Clinical Study Synopses and protocol sections, Clinical Study Reports (CSRs), Paediatric Investigation Plans (PIP) and responses to competent regulatory agencies
- Overseeing PK (Phoenix/Winonlin) and PBPK (Simcyp TM) modelling directed at understanding clinical PK, PKPD, paediatric PK modelling and prediction of human PK and dose
**ABOUT YOU**:

- Academic degree(s) with focus in pharma/biotech or any other related field.
- Strong experience in DMPK & clinical Pharmacology
- You have good analytical and synthesis skills as well as diligence and team spirit
- Fluency in English is required, German or French would be an asset.

**WHAT WE OFFER**:

- A permanent contract and innovative projects
- An attractive remuneration policy
- Personalized management and continuous learning to develop your career
- Great team spirt and an integration within the "Tribe"

**Job Types**: Full-time, 90-100%, Permanent

Schedule:

- Monday to Friday
Work Remotely:

- Temporarily due to COVID-19

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