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Clinical Development Director in Dermatology (Clinical Program Leader)-M / F

Pierre Fabre Group

Occitanie

Hybride

EUR 60 000 - 100 000

Plein temps

Il y a 4 jours
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Résumé du poste

An established industry player is on the lookout for a Clinical Program Leader in Dermatology to spearhead clinical studies and enhance patient safety. This role involves collaborating with multidisciplinary teams, interpreting clinical data, and acting as a Subject Matter Expert. If you have a Ph.D. or a Medical Degree with significant experience in clinical development, and you thrive in a dynamic environment, this opportunity could be your next career milestone. Join a forward-thinking company committed to innovation and excellence in the field of Dermatology.

Qualifications

  • Ph.D. or Physician specialized in immunology and/or Dermatology.
  • 5+ years of experience in clinical development within biotech/pharma.

Responsabilités

  • Lead and manage clinical studies in Dermatology diseases.
  • Ensure patient safety and compliance with regulatory guidelines.
  • Deliver high-quality scientific assessments for new product opportunities.

Connaissances

Clinical Development
Leadership
Communication
Negotiation
Problem Solving
Organizational Skills
Collaboration
Multidisciplinary Teamwork
Presentation Skills

Formation

Ph.D. in Immunology or Dermatology
Medical Degree

Description du poste

We are seeking a talented and highly motivated Clinical Program Leader in Dermatology (Clinical Development Director) to develop and enhance experience in the 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 expertise in this therapy area, where you are deeply committed to acting as the main reference point.

You will contribute to the production of the Common Technical Document, including validation of scientific documents relevant to the clinical studies (e.g., study protocol, CRF, Investigator Brochure, clinical study report), and represent the Company before institutional authorities.

More precisely :
  • Work closely with the BD department to scout and assess multiple assets to grow the pipeline in Dermatology.
  • Act as Medical Expert, in cooperation with Study Team Members, to deliver results of Clinical Studies and related Key Clinical Documents, in accordance with the Clinical Development Plan and timelines.
  • Interpret clinical data.
  • Ensure patient safety in collaboration with Corporate Pharmacovigilance, including ongoing risk-benefit assessment and safety signal detection during studies.
  • Meet the needs of internal and external stakeholders as Subject Matter Expert, maintaining and enhancing knowledge, and securing timely publication of clinical data.
  • Apply up-to-date trial designs by partnering with relevant disciplines.
  • Design post-registration clinical studies.
  • Organize EU and extra-EU Advisory Boards and represent the Company before Institutional Authorities, including Data Safety Monitoring Boards.
  • Act as medical writer/reviewer when required, ensuring compliance with ICH/GCP, SOPs, and Regulatory Guidelines.
  • Deliver high-quality scientific and clinical assessments of new product opportunities for in-licensing in Dermatology, including clinical development plans and lifecycle management.

High flexibility regarding the location of this position.

Who you are ?

Ph.D. or Physician specialized in immunology and/or Dermatology with at least 5 years of experience in clinical development within the biotech/pharma industry.

Skills

Goal-oriented, excellent communicator, collaborative, capable of defining operational priorities and setting demanding objectives.

Able to lead, negotiate, solve problems, and influence quality of deliverables.

Excellent organizational skills, with the ability to multi-task and prioritize.

Excellent English written and oral communication skills, including presentation skills.

Strong leadership skills and experience working in a dynamic, multidisciplinary environment.

Self-motivated, collaborative, with the ability to work with multidisciplinary teams and external partners.

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