Clinical Development Director in Dermatology

il y a 2 semaines


Toulouse, Occitanie, France Pierre Fabre Group Temps plein
Job Title: Clinical Development Director in Dermatology

We are seeking a highly motivated and experienced Clinical Development Director in Dermatology to join our team at Pierre Fabre Group.

About the Role

As a Clinical Development Director in Dermatology, you will be responsible for developing and enhancing experience in design and management of clinical studies in Dermatology diseases, working in collaboration with the Clinical Team.

You will support the relevant clinical studies for the medical/scientific aspects, especially those requiring this therapy area expertise, where you are deeply committed to acting as the main reference point.

Key Responsibilities
  • Work in close collaboration with the Business Development department to scout and assess multiple assets to grow the pipeline in Dermatology.
  • Acting as Medical Expert, in cooperation with other Study Team Members, to deliver results of the assigned Clinical Studies and related Key Clinical Documents, in accordance with the Clinical Development Plan and the related agreed timelines.
  • Responsible for interpretation of clinical data.
  • Ensure the safeguard of Patients Safety: in collaboration with and in support of Corporate Pharmacovigilance. Ensure the on-going risk benefit assessment, caring the safety and efficacy signal detection/response during conduct of assigned studies.
  • Aim at meeting the needs of internal and external stakeholders, acting as Subject Matter Expert in the assigned product(s) and relevant disease(s) area, maintaining and enhancing knowledge, securing timely publication of all clinical data.
  • Ensure application of up-to-date trial designs by partnering with all relevant disciplines.
  • Cooperate in the design of post-registration clinical studies
  • Organize EU and extra-EU Advisory Boards. Represent the Company in front of Institutional Authorities, representing Pierre-Fabre Clinical Expertise in public sessions of Data Safety Monitoring Board Meetings.
  • Act as medical writer/reviewer when required and in general act in compliance with ICH/GCP, SOPs and Regulatory Guidelines.
  • Accountable for the delivery of high-quality scientific and clinical assessment of new product opportunities for in-licensing in Dermatology, including the hypothesis for the clinical development plan (including standardized costs) and life-cycle management, and the clinical/development risks.
Requirements

We are looking for a Ph.D or Physician specialized in immunology and/or Dermatology with at least 5 years of experience in clinical development in biotech/Pharma industry.

The ideal candidate will have excellent communication and leadership skills, with the ability to work collaboratively and prioritize tasks effectively.

High flexibility about the location of this position.



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    {"title": "Clinical Development Director in Dermatology", "content": "Key ResponsibilitiesWe are seeking a highly motivated Clinical Development Director in Dermatology to develop and enhance experience in design and management of clinical studies in Dermatology diseases, working in collaboration with the Clinical Team.You will support the relevant clinical...


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