Head of Cell & Gene Therapy, G&L Scientific US
We are excited to have an opening in G&L’s core team of consultants, based in the US. The role will be joining G&L’s leadership team, with responsibilities across the Gene and Cell therapy areas. G&L have a growing pipeline of ATMP client projects and this new position is in response to this uptick. The ideal candidate will have a strong background in regulatory affairs, with particular interest and experience working with cell and gene therapies. We are looking for strong technical expertise, but also someone who has a keen interest in building G&L’s footprint and team of consultants who work in this area.
- Define strategies and provide tactical guidance to client’s biological/cell and gene therapy programs
- Demonstrate ability to anticipate risks, be responsible for developing solutions to identified risks, discuss with team and management, and understand probabilities of technical success for the solutions
- Prepare a target product profile (TPP) to guide the development plan and communicate product attributes to stakeholders
- Build a regulatory strategy to facilitate successful pre-IND/IND meetings expedited programs (e.g., RMAT)
- Serve as biologics/cell/gene therapy expert on business development calls; represent G&L Scientific at scientific conferences, industry events.
- Anticipates, evaluates and implements trends and innovation in the gene and cell therapy area
- Provides technical expertise and consulting to technical and business strategies.
- Accountable for the development of organizational structure and capabilities of cell and gene therapy center of excellence service area.
- Responsible for management of resourcing and budget planning for his/her area of focus
- Provide leadership and development for direct reports
- Highly motivated leader with substantial experience in vector design and gene therapy drug development experience
- Degree in science-related field, advanced degree appreciated
- 15+ years of regulatory experience required; biologics experience preferred
- Prior managerial experience is also required.
- Previous experience successfully leading an external collaboration (academic and/or industry) involving design of study plan, oversees execution and frequent evaluation of results to provide decision recommendations.
- Diplomacy and positive influencing abilities with excellent communication skills
- Referred experience in reviewing, authoring, or managing components of regulatory submissions
- ability to understand and interpret complex scientific issues across multiple projects as it related to regulatory
- Analytical and problem solving skills: ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
- Strategic Implementation: ability to develop, implement and monitor the overall clinical operations strategy
- Management of multiple tasks of varied complexity simultaneously
- Ability to work in a demanding environment with aggressive project timelines
- Our team of consultants are expected to be ambassadors for G&L – working directly with clients and Health Authorities – so therefore we really value communication skills and the art of negotiation and diplomacy.
- All our staff are encouraged to have the confidence to speak their mind and suggest new ideas. All our consultants are expected to act as mentor to junior staff, contributing to the development of graduate and junior training programmes.
- Above all, our company is all about our people – so you should have a passion for meritocracy, recognition and development.
- We hope that you will feel excited about making suggestions or challenging existing methodologies! G&L’s reputation has been built on our customer service and client-focus – so any ideas that will help us stay ahead of the curve are encouraged!
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