Clinical Development Director in Rare Diseases
il y a 2 semaines
Your Mission
We are seeking a talented and highly motivated Clinical Program Leader in Rare Diseases 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.
Key Responsibilities
- Work in close collaboration with the BD department to scout and assess multiple assets to grow the pipeline in rare diseases.
- Acting 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 on-going 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.
Requirements
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.
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