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

TN France; Toulouse; À distance; EUR 60 000 - 100 000; Plein temps

Résumé du poste

An established industry player is looking for a Clinical Development Director specializing in rare diseases. This pivotal role involves leading clinical studies, ensuring patient safety, and collaborating with cross-functional teams. The ideal candidate will have a Ph.D. or medical degree with expertise in immunology or hematology, along with a proven track record in clinical development. This position offers high flexibility regarding location and the chance to make a significant impact in the field of rare diseases. Join a dynamic team that values collaboration, innovation, and excellence in scientific research.

Qualifications

• Ph.D or Physician with 5+ years in clinical development in biotech/Pharma.
• Experience in leading clinical studies and managing cross-functional teams.

Responsabilités

• Develop and manage clinical studies in rare diseases.
• Ensure patient safety and compliance with regulatory guidelines.
• Act as Medical Expert and Subject Matter Expert in assigned areas.

Connaissances

Goal-oriented

Excellent communicator

Leadership skills

Organizational skills

Problem-solving

Collaboration

Presentation skills

Formation

Ph.D or Physician specialized in immunology

Specialization in hematology or metabolic disorders

Description du poste

Social network you want to login/join with:

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

col-narrow-left

Client:

Location:

Toulouse, France

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

e8ea1e42aebf

Job Views:

4

Posted:

29.04.2025

Expiry Date:

13.06.2025

col-wide

Job Description:

Your mission

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

You will contribute to the production of the Common Technical Document, in terms of validation of scientific documents relevant to the concerned clinical studies (e.g., study protocol, CRF, Investigator Brochure, clinical study report), also representing the Company in front of the institutional authorities concerned.

• Work in close collaboration with the BD department to scout and assess multiple assets to grow the pipeline in rare diseases.
• Act 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 ongoing 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 rare diseases, including the hypothesis for the clinical development plan (including standardized costs) and life-cycle management, and the clinical/development risks.

High flexibility about the location of this position.

Who you are ?

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

Skills

Goal-oriented, excellent communicator, work collaboratively

Defines operational priorities and assigns ambitious and demanding objectives

Able to lead, negotiate and solve problems, influence the quality of the 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 environment

Self-motivated and collaborative with ability to work with multi-disciplinary teams and external partner.