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Specialist Nonclinical Development (m/f/d)
Project Context
For a mid-sized, internationally operating pharmaceutical company, we are looking for an experienced freelance specialist in nonclinical drug development.
The assignment is embedded in a lean Pharmacology & Toxicology function with a broad product portfolio (including small molecules, biologics and cell therapies) and a pragmatic development approach.
All nonclinical activities are outsourced and scientifically coordinated internally.
The focus of the project is the independent handling of nonclinical topics related to product lifecycle management, indication and country extensions, as well as the evaluation of new development opportunities.
Tasks & Responsibilities
Preparation, update and maintenance of Nonclinical Overviews, including:
Indication extensions
Country and regulatory extensions
Authoring and updating nonclinical CTD / dossier content, including summary and overview documents (e.g. DESO updates)
Scientific planning, evaluation and coordination of externally conducted nonclinical studies, including:
Definition of study scope and requirements
Scientific assessment of study designs and results
Derivation of regulatory-relevant conclusions
Scientific evaluation of specific nonclinical questions, such as:
Assessment of impurities / impurities-related topics
Relevance of nonclinical data for new indications
Contribution to a specific nonclinical development project with a biological / immunological focus (e.g. cell therapy, novel therapeutic approaches)
Scientific contribution to additional ongoing nonclinical development projects
Evaluation of nonclinical data in the context of in-licensing and development opportunities
Required Qualifications
Several years of experience in nonclinical drug development within the pharmaceutical industry
Scientific background with a focus on biology, immunology, biologics or cell therapy
Proven experience in the preparation and review of regulatory nonclinical documentation (EU/ICH)
Confident interaction with external service providers and study partners
Ability to structure, assess and document complex nonclinical topics in a regulatorily robust manner
Highly independent, reliable and responsible working style
Project Details
Start: Mid-March
Workload: approx. 20 hours per week
Duration: approx. 12 months
Working model: predominantly remote
Language: English in day-to-day project work, German is a plus, but not essential
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