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

Pierre Fabre Group; Occitanie; Sur place; EUR 60 000 - 100 000; Plein temps

Résumé du poste

An established industry player is seeking a Clinical Program Leader to spearhead clinical studies in rare diseases. This pivotal role involves collaborating with the Clinical Team to design and manage studies, ensuring patient safety, and acting as a Subject Matter Expert. The ideal candidate will possess a Ph.D. or medical degree in relevant fields, with a strong background in clinical development within the biotech or pharma sectors. Join a dynamic team where your expertise will drive innovative solutions and contribute to the advancement of critical therapies. If you are goal-oriented, an excellent communicator, and thrive in collaborative environments, this opportunity is perfect for you.

Qualifications

• Ph.D. or Physician with 5+ years in clinical development.
• Specialized in immunology, hematology, or metabolic disorders.

Responsabilités

• Lead clinical studies in rare diseases and collaborate with the Clinical Team.
• Ensure patient safety and manage clinical data effectively.

Connaissances

Goal-oriented

Excellent communicator

Collaborative

Leadership skills

Negotiation skills

Problem-solving skills

Organizational skills

Proficient in English

Multi-tasking abilities

Formation

Ph.D. in Immunology

Physician specialized in hematology

Physician specialized in metabolic disorders

Description du poste

We are seeking a talented and highly motivated Clinical Program Leader in Rare Diseases (Clinical Development Director) to develop and enhance experience in the design and management of clinical studies in rare diseases, working in collaboration with the Clinical Team.

You will support relevant clinical studies for the medical/scientific aspects, especially those requiring expertise in this therapy area, acting as the main reference point.

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

More precisely :

1. Work closely with the BD department to scout and assess multiple assets to grow the pipeline in rare diseases.
2. 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.
3. Interpret clinical data responsibly.
4. Ensure patient safety by collaborating with Corporate Pharmacovigilance, conducting ongoing risk-benefit assessments, and managing safety and efficacy signals during studies.
5. Meet the needs of internal and external stakeholders, acting as Subject Matter Expert in the relevant disease area, maintaining and enhancing knowledge, and securing timely publication of clinical data.
6. Apply up-to-date trial designs by partnering with relevant disciplines.
7. Assist in designing post-registration clinical studies.
8. Organize EU and extra-EU Advisory Boards and represent the company before Institutional Authorities, including Data Safety Monitoring Board Meetings.
9. Serve as medical writer/reviewer when needed, complying with ICH/GCP, SOPs, and Regulatory Guidelines.
10. Be accountable for high-quality scientific and clinical assessments of new product opportunities in rare diseases, including clinical development plans, lifecycle management, and risk assessment.

Location flexibility is required for this position.

Who you are ?

Ph.D. or Physician specialized in immunology, hematology, or metabolic disorders, with at least 5 years of experience in clinical development within the biotech/pharma industry.

Skills

• Goal-oriented, excellent communicator, collaborative
• Ability to define operational priorities and set ambitious objectives
• Strong leadership, negotiation, and problem-solving skills; capable of influencing quality
• Excellent organizational skills with multi-tasking and prioritization abilities
• Proficient in English (written and oral), with strong presentation and communication skills
• Leadership experience in dynamic, multidisciplinary environments
• Self-motivated, collaborative, with the ability to work with diverse teams and external partners