Clinical Development Director in Rare Diseases

il y a 1 mois


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

We are seeking a highly motivated and experienced Clinical Development Director to lead our efforts in rare diseases. As a key member of our Clinical Team, you will be responsible for developing and enhancing our experience in design and management of clinical studies in rare diseases.

Key Responsibilities:
  • Work closely with the Business Development department to identify and assess new assets to grow our pipeline in rare diseases.
  • Act as a Medical Expert, collaborating with other Study Team Members to deliver results of assigned clinical studies and related Key Clinical Documents, in accordance with the Clinical Development Plan and agreed timelines.
  • Responsible for interpreting clinical data and ensuring patient safety.
  • Collaborate with Corporate Pharmacovigilance to ensure the safeguard of patient safety and ongoing risk-benefit assessment.
  • Act as a Subject Matter Expert in assigned products and relevant disease areas, maintaining and enhancing knowledge, and securing timely publication of all clinical data.
  • Partner with relevant disciplines to apply up-to-date trial designs.
  • Cooperate in the design of post-registration clinical studies.
  • Organize EU and extra-EU Advisory Boards and represent the Company in front of Institutional Authorities.
  • Act as a medical writer/reviewer when required and ensure compliance with ICH/GCP, SOPs, and Regulatory Guidelines.
  • Accountable for delivering high-quality scientific and clinical assessment of new product opportunities for in-licensing in rare diseases.
Requirements:
  • Ph.D. or Physician specialized in immunology and/or hematology, with at least 5 years of experience in clinical development in biotech/Pharma industry.
  • Goal-oriented, excellent communicator, and able to work collaboratively.
  • Defines operational priorities and assigns ambitious objectives.
  • Able to lead, negotiate, and solve problems, influencing the quality of deliverables.
  • Excellent organizational skills, with ability to multi-task and prioritize work.
  • Excellent English written and oral, presentation, and communication skills.
  • Great leadership skills and experience working in dynamic multidisciplinary environments.
  • Self-motivated and collaborative, with ability to work with multi-disciplinary teams and external partners.

We offer a dynamic and challenging work environment, with opportunities for growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.



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