Director, Clinical Development & Medical Affairs
Medical Director, Clinical Development & Medical Affairs
At AviadoBio our mission is to transform the lives of people living with neurodegenerative disorders by developing and delivering transformative gene therapies for diseases including frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS).
The company’s technology is based on pioneering research of Professor Christopher Shaw, Professor of Neurology and Neurogenetics, Kings College London, with the support of UK Dementia Research Institute. With support from leading life science investors our experienced and talented team is poised to make a meaningful impact to people living with neurodegenerative disease.
We are rapidly building a passionate team that can help deliver on this mission. It is a great time to join what is a truly innovative and exciting gene therapy company at an early stage; where your work will be impactful and you will benefit from a collaborative, inclusive, open and friendly working environment that promotes both professional development and fun.
There is a tangible air of excitement and an unwavering belief that the work we do each day will contribute to patients.
We are seeking a Director with clinical background and clinical research and medical affairs experience who is driven by the desire to develop potentially transformative treatments for patients with neurodegenerative diseases.
This position sits within the Clinical Sciences group, reporting to the Senior Director, Clinical Development and Medical Affairs (CDMA), who provides CDMA leadership across the portfolio. This role is an excellent opportunity for significant growth and development, in a fast-paced, dynamic biotech environment.
As a core member of the Clinical team, the Director, Clinical Development, will provide expert medical, scientific and strategic input to help drive the successful planning and execution of clinical stage programmes. This highly visible position that will interact extensively with cross-functional groups internally, as well as representing the company with external stakeholders where appropriate.
Main purpose/key responsibilities of the role:
- Become an internal medical expert for the asset and/or disease area for which you will be responsible
- integrate up-to-date disease area knowledge, knowledge from the external medical and patient/caregiver community etc. into the clinical team plans/deliverables
- Clinical development activities:
- Maintain oversight of assigned medical monitoring activities
- Review and processing of protocol deviations and medical data on an ongoing basis
- Work collaboratively with internal and CRO cross-functional team members of study management teams to deliver clinical trial(s)
- Provide scientific input and contribute to the creation/ongoing updates of relevant clinical documents e.g. Investigator Brochures, Study Protocols and Clinical Study Reports
- Provide organizational support for the independent Data Monitoring Committee including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications
- Contribute to the development and maintenance of an engaged external network to support delivery of Clinical Programme(s)
- Regularly engage with investigators and clinical study site staff, CRO representatives etc. to maintain enthusiasm and support for ongoing clinical studies
- Support the planning and execution of Investigator Meetings and other study related engagements
- Create and deliver study- and/or programme-related scientific training to internal and external stakeholders
- Medical affairs activities:
- develop and maintain relationships with KoL network and relevant external stakeholders
- scientific leadership, including
- external representation of CDMA function at scientific and other meetings
- ownership of strategic publications plan and subsequent Integrated Evidence Plan for assigned asset/programme
- medical input to external (e.g. clinicians, patients/caregiver/advocate) engagement activities
- medical review and approval of asset- and disease-area related materials generated by cross-functional teams to ensure accuracy and quality
- assigned project-related medical affairs vendor oversight and management
- MD or PhD in relevant discipline
- Experience in core clinical development activities e.g. authorship and/or review of study documents; oversight of medical monitoring activities
- Experience in medical affairs e.g. KoL mapping, relationship building and management, scientific publication planning and execution, integrated evidence plan development
- Significant experience in at least one highly relevant area of clinical research e.g. gene therapy, neurodegenerative disease, Ph1/2 clinical development, rare disease
- Ability to represent the CDMA function on cross-functional project teams, committees, and external committees/meetings
- Eager to work in a fast-paced, rapidly changing environment
- Up to 25-30% travel
- Competitive Salary
- Annual Bonus
- Exciting Equity Plan
- Pension Scheme
- Private Healthcare
- Fantastic Maternity Leave policy
- Childcare/Nursery scheme
- Cycle to Work scheme
- Discount club
- Gym benefits
- Life Insurance
- Income protection