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Principal Scientist Nonclinical Pharmacology Biosimilars

Employer
Proclinical Staffing
Location
Aubonne, Switzerland
Salary
Negotiable
Start date
13 Apr 2021
Closing date
27 Apr 2021

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Discipline
R & D , Scientific
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

A global healthcare company that specializes in lifesaving medicines is looking for an experienced Senior Manager- Principal Scientist of Nonclinical Pharmacology Biosimilars. The Swiss based role is dedicated to creating products and services that are used to help care for critically and chronically ill patients.

 

Job Responsibilities

  • Provide nonclinical pharmacology expertise to biosimilar development and knowledge on biological mechanisms of action of drugs in support of similarity and extrapolation of indications. Support CMC analytical quality and nonclinical pharmacology from characterization of the originator drug to commercial stage using literature and nonclinical pharmacology data relative to structure-function relationship. Design and implement CMC pharmacodynamics and nonclinical pharmacology study plans for biosimilars development projects, highlight risks and issues, and propose mitigation plans. Assess the overall similarity of the products' biological activity. Assess product analytical quality data for its relevance at functional level for potential impact on safety and efficacy in the clinic, propose and implement justification packages in support of similarity and extrapolation of indications. Write and review CMC and nonclinical pharmacology sections for dossiers delivered to regulatory agencies.


Skills and Requirements

  • Scientific degree (PhD) in Biology, Immunology, Pharmacology or related field Fluency in English essential, both oral and written Industry and academic experience with in vitro, ex vivo and in vivo non-clinical pharmacology, auto-immunity and inflammation, and oncology. Minimum 10 years of relevant experience in R&D of biopharma/biotech industry, including at mid-management level A successful track record with CRO/CMO management for CMC and nonclinical pharmacology, ideally for biosimilars. Good background or understanding of CMC analytical development, process development and manufacturing of biologics in general.

 

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies

#LI-AB1

#Scientific

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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