Sector: Life Sciences
Consultant: Life Sciences Team
Salary: £105400 - £131800
Job Status: Permanent / Full Time
Job Title: Clinical Research Director
Location: Paris, France
Reporting to: Chief Medical Officer
Renumeration: €120,000-€150,000 depending on expierence
Contract Type: Full Time and Permanent
This is a full-time position, based in the Headquarter (Paris), with a direct reporting to the Chief Medical Officer (CMO). The Clinical Research Director develops promising company molecules into medicine that fulfil patient’s needs and provides them with the best value. While having a strong knowledge in GCP, clinical studies management and regulatory requirements, he/she works in close collaboration with the CMO, the Clinical Research Scientist (CRS) and with cross-functional clinical study teams, and provides clinical science support for assigned programs.
Responsibilities of the position:
- Support development of clinical development plans and protocols for clinical studies
- Prepare and/or provide input to clinical study related and regulatory documents (e.g. Protocols, CSRs, IBs, SAPs, Data Management Plans, IND, briefing books, DSURs, study and central reader manuals, CRFs…)
- Coordinate and prepare medical parts of Regulatory Dossiers
- Review of patient profiles and listings as well as queries generation as needed
- Monitor, review and interpret safety and efficacy data of ongoing studies as needed
- Represent clinical R&D in cross-functional project core teams
- Act as (clinical science expert) liaison to clinical study teams, regulatory teams and others
- Participate in cross-functional clinical study team meetings
- Support Clinical Operations for clinical studies recruitment as needed
- Establish relationships with KOLs, partners and appropriate consultants
- Act as a Chief Patients Officer, interact with Advocacy Groups and ensure medical information, as appropriate
- Provide clinical scientific input to business development (e.g. due diligence) and marketing activities
- Develop and deliver presentations to internal and external stakeholders
- Participate in SOPs creation, update and writing in his/her area of expertise
- Pharmacist/PhD/Advanced degree in life sciences/healthcare
- Scientific expertise in the field of orphan drugs, gene therapy and/or ophthalmology is a plus
- Minimum of 5 years’ experience in clinical development in biotech or pharmaceutical industries.
- Well-versed in medical aspects of GCP ,ICH, FDA, EMEA and other relevant guidelines and regulations
- Has experience in Regulatory filing and is skilled to lead and supervise the preparation and constitution of the medical parts of FDA and EMA registration dossiers
- Has knowledge of the multidisciplinary functions involved in drug development process (e.g.: clinical operations, biostatistics, regulatory, business, etc.) and can proactively integrate multiple perspectives into the clinical development process for best end-results.
- Excellent project management skills. Focused on results, flexible and open-minded, able to adjust to changing circumstances.
- Ready to travel up to 20% of time including international travels.
If this role is of interest, please click apply now. For more information please contact Sam Crossman in the Life Sciences team.