Clinical Development Director in Rare Diseases
il y a 4 semaines
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 ongoing risk-benefit assessment and safety signal detection/response during study conduct.
- Meet the needs of internal and external stakeholders by acting as a Subject Matter Expert in assigned products and relevant disease areas, maintaining and enhancing knowledge, and securing timely publication of clinical data.
- Apply up-to-date trial designs by partnering with relevant disciplines.
- Contribute to 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, including hypothesis for the clinical development plan and life-cycle management.
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 collaborative team player.
- 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.
About Pierre Fabre Group:
Pierre Fabre Group is a leading international pharmaceutical company dedicated to improving the health and well-being of people around the world. We are committed to innovation, quality, and patient-centered care.
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