PK Senior Scientist - Dermatology

Valesta is seeking a senior pharmacokineticist to join the Preclinical Development group. The candidate should possess an in-depth understanding of pharmacokinetics applied to dermatology and have experience in designing and critically evaluating results of GLP-compliant toxicokinetic studies and clinical pharmacokinetic studies as well as in the preparation of documents for regulatory submission.  . 

Job Description 

Functions and responsibilities

 

  1. Responsible of PK and Drug Metabolism activities ensuring that they are completed within approved budgets, plans and timelines.

  2. Contribute to Project Teams strategy and execution of development project plans

  3. Management of outsourced studies (budget, quality, timelines, etc.)

  4. Contribution to the interpretation and overall DMPK assessment ofcompounds in development

  5. Provide technical input to the regulatory process and interaction with international Regulatory Agencies

     

  6. Ensure that DMPK activities are fully integrated with Preclinical Safety Assessment appraisal

     

  7. Provide advice to Pharmaceutical, Clinical and Regulatory Affairs departments, as well as to other business divisions of the company to support the DMPK assessment of products in development or marketed products

     

  8. Support Business Development out- and in-licensing activities

     

Education

 

  • Bachelor degree in Pharmacy or related life sciences.

  • PhD in Pharmacokinetics, Pharmaceutical Sciences, or other life sciences field.

 

Experience

  • Minimum 5 years of professional experience required, including experience in the biopharmaceutical industry

  • Experience in authoring reports andCTD documents, IND/IMPD through MAA/NDA, for submission to EMA/FDA and other regulatory agencies.

 

Specific knowledge

 

  • High level of English, essential.

  • Spanish, desirable.

  • Understanding of selection strategy for derma formulation, characterization of PK, bio distribution and PK/PD relationships

  • Working knowledge of common tools in dermatology research such as in vitro models, nonclinical models and application of Modelling and Simulation strategies

  • Ability to provide expert guidance and lead and/or influence research and development teams

  • Provide expert representation to inter-departmental due diligence teams.

  • Strong interpersonal communication skills and an ability to present effective and succinct points of view to influence the programmes/projects through scientific debate

Application form : PK Senior Scientist - Dermatology

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