|Job title :||Sr Medical Director, Clinical R&D - Neurology|
|Job type :||Permanent|
|Contact name :||Sergio Carito|
|Contact number :||+44 (0) 207 255 6650|
|Contact email :||firstname.lastname@example.org|
A highly innovative Gene Therapy Biotechnology company focused on the development & commercialisation of cutting-edge treatments for rare neurological disorders is currently looking to hire a physician to join their multi-national Clinical Development unit in the capacity of Senior Medical Director. This new vacancy represents a fantastic opportunity to join an exceptional team with a wealth of experience, developing gene therapies which make a huge impact on the patients and families that have been devastated by serious genetic, neurodegenerative, rare disease.
Key tasks will be the design, conduct, execution and reporting of clinical studies, in addition to the responsibility to provide support to the EMEA commercial organisation and to interact with regulatory authorities. Some of the key specific responsibilities will include:
*Cross-functional collaboration to develop clinical plans and global regulatory submissions.
*Partnership with Clinical Operations to ensure efficient clinical study activities.
*Clinical data review and support to clinical and regulatory documentation.
*Identification, management, and interaction with vendors, collaborators, and KOLs.
*Clinical study design, medical monitoring and execution, and results analysis.
*Professional relationships with academic and community-based study sites, identifying investigators and clinical academic experts.
*Incorporate Health Economics Outcomes Research requirements into protocol design.
*May potentially directly line manage up to 3x line reports in the clinical development team.
We would like to speak with pharmaceutical industry physicians based anywhere in Europe with extensive clinical development experience in relevant fields, used to working within a matrix, multi-located structure, and willing to travel when safe and according to business needs. Specific experience and skills include we are looking for include but are not limited to:
*Medical Degree (MD) with qualifications in Neurology, Paediatrics, Genetics or CNS background.
*A minimum of 3 years' industry experience, though those with strong academic clinical research experience could be considered at a Medical Director level.
*Demonstrable knowledge of regulatory procedures internationally, with prior experience in US and/or European regulatory filing.
*The ideal candidate would have prior experience with neurological/neuromuscular and/or orphan products.
*Additional postdoctoral training or additional qualifications such as PhD, PharmD, certificate in Pharmaceutical Medicine would be preferred but not a mandatory requirement.
The company offers a very competitive remuneration, a unified and collaborative team of professionals, and the chance to play as a lead contributor to the development of gene therapies with the potential to positively impact the lives of patients and their families.