about 2 years ago
Clinical Development Director - EMEA
A clinical stage biotech is expanding their R&D team as they drive forward European based Phase III trials in Rare Neurological Diseases. With Orphan Drug Designation, Breakthrough Therapy Designation, and Fast Track Designation for the lead candidate things are looking promising for regulatory approval by major jurisdiction.
In addition to trials at Phase III our client has early Phase I research ongoing using a similar Gene Therapy approach in other Rare Neurological conditions.
The Clinical Development Director will report into the Executive Clinical Development Director and be responsible for contributing to the day-to-day execution, medical monitoring, design, and data review of clinical studies.
It's worth noting that this role can be based anywhere in Europe and will require the successful candidate to travel regularly within the region.
- Provide oversight and management of clinical studies
- Partner with Clinical Operations to ensure all activities are completed in a timely manner in accordance with applicable regulations and guidance
- Review clinical data from all phases of development and assist in generating study reports, publications and regulatory documents
- Work cross functionally with Clinical Trial Teams, Regulatory, and Drug Safety and external vendors (CROs etc.) to ensure objectives are reached
- Act as the Medical Monitor for studies
- Manage and identify external collaborators, investigators, key clinical academic experts and KOLs
- Ensure compliance with all applicable regulatory standards related to global clinical trials
- Develop and maintain effective relationships with thought leaders
- Support other business functions as required
- Medical Degree (MD) with further qualifications in Neurology or Paediatrics and Certificate in Pharmaceutical Medicine preferred
- Additional therapeutic expertise in Neuromuscular or Neurodegenerative diseases (especially rare) is an advantage
- Gene Therapy experience would also be advantageous
- Experience in drug development within the pharma/biotech industry and a relevant therapeutic field
- Experience in clinical study design, medical monitoring and results analysis
- Demonstrable knowledge of designing, implementing, conducting, reviewing and presenting clinical studies
- Experience in EMA regulatory filing would be beneficial
- Demonstrable working-knowledge of regulatory procedures and guidelines across EMEA
- Comfortable with or has experience in working in a small company setting
- Fluent in English, additional EMEA languages are a plus
Salary & Benefits Package:
- The successful candidate will be offered a competitive basic salary and benefits package with long term incentives
To apply for this position please use the "Apply" option or feel free to send your CV directly to the Pharma-Partners team via email email@example.com