Career Opportunities in the Foresite Capital Network

Location: Babraham Research Park, Cambridge
Type: Full time, permanent
Start: Immediate
Salary: Competitive / Hours: 40 p/w
Office Based Position

Cambridge Biotech of the Year 2022

bit.bio is an award-winning spinout from the University of Cambridge. Our breakthrough technology combines synthetic and stem cell biology for the precise, efficient and consistent reprogramming of human cells used in research, drug discovery, and cell therapy. At bit.bio, we are passionate about engineering human cells that will enable the medicine of the future. To do this we need talented and curious people who want to make an impact on the future of science and therapeutics.

As a team of individuals, we value science, collaboration, openness, curiosity and creativity. We are united by trust and respect for each other.

Your role in our team:

We are looking for a Senior Director, In-Vivo Cell Therapy Innovation, with a strong background in pre-clinical in-vivo research to support our efforts in delivering our cell therapy ambitions and growing portfolio.

This role reports directly to the head of the Cell Therapy Innovation (CTI) group, within R&D. CTI has been formed to spearhead discovery research from project inception and CTA/IND-enabling pre-clinical efforts for our therapeutic programs. As senior director, you will lead a team of scientists to characterise the safety and efficacy of cell therapies, spanning in vitro and in vivo methodology. You will also represent CTI on development project team(s), taking accountability for the pre-clinical workstream, including writing pre-clinical sections of regulatory documents and representing pre-clinical in regulatory interactions.

This is an exceptional opportunity to become part of an expanding cell therapy team focused on the delivery of bit.bio’s therapeutic mission.

Your key responsibilities will include:

• Accountable for the pre-clinical work package to support a regenerative therapeutic cell program clinical trial application, including:
• representation of pre-clinical at the program team
• leading the work packages within CTI and external CROs.
• writing the pre-clinical sections of regulatory documents and representation of bit.bio at regulatory interactions.
• Leadership of a team of scientists involved in in-vitro and in-vivo safety and efficacy evaluation of cell therapies across different therapeutic areas including regenerative, neuroscience & immunology therapeutic areas.
• To help build and develop the team, according to company goals and priorities.
• Accountable for in-vivo studies across therapeutic areas to candidate selection. To establish and develop in-vivo capability within bit.bio, contributing expertise across projects
• Design, and contribute towards the execution of experimental assays, both internally and externally through management of CRO partners, required to characterise cell activity according to the Program needs.
• Independently drive projects and actively contribute to projects of others to meet clinical objectives by engaging cross-functionally with Research, PM, Cellular Engineering, Manufacturing Development and Production.
• Establish processes within the team to support regulatory submissions, for example report writing.

You…

• Have a PhD in a relevant area of Biological Science, or equivalent, and extensive experience in a similar role within the pharma/biotech environment
• Have a strong background in pre-clinical research that includes in-vivo and in-vitro methodology
• Are a strong communicator at all levels within an organisation as well as externally with KOLs and Advisors
• Are data driven and solutions oriented; have strong influencing and decision making skills; and have the ability to impart technical/scientific information to a wide audience
• Have a passion for innovation and the drive to succeed in designing new cell therapies to bring into clinical trials

With essential experience in…

• Strong understanding of pre-clinical development including previous experience in generating CTA (or IND) enabling data packages to support first in man clinical trials.
• Experience in regulatory writing and/or regulatory interactions
• Experience of conducting in-vivo studies to evaluate safety and/or efficacy, preferably in the cell and gene therapy area.
• Ability to engage and lead discussions with external pre-clinical and clinical KOLs and advisors.
• Experience of contracting-out work and managing contract research organisations.
• A strong track record and practical experience of driving project success in a collaborative environment.
• Experience of leading and managing a group of direct reports.

…and possibly…

• Knowledge and/or experience of hepatocyte and liver biology
• Practical and theoretical background in hESC or hIPSC culture and differentiation/ reprogramming
• Well-rounded practical experience and knowledge of cellular assays and cell phenotyping (e.g. immunocytochemistry, flow cytometry).
• Well-rounded and practical experience in molecular assays, molecular biology, and their downstream analysis (qRT-PCR, bulk and scRNA seq).
• Experience and understanding of introducing novel workflows/processes and development for screening of cellular differentiation/reprogramming.

More reasons to join us:

bit.bio provides a vibrant and dynamic work environment in an exciting, fast-moving time for biology. We work with cutting edge technologies and with our world-leading scientific advisory board. We conduct pioneering work with real-world impact.

We trust our people to make significant contributions early on with opportunities to be involved in projects that are key to the success and growth of our young company. We invest in people, creating opportunities for personal development in an inclusive multi-skilled team with ambitious goals that provide opportunities to learn on the job from each other.

Creativity and open minds are encouraged for everyone to contribute to the success of the company.

To support bit.bio staff and our culture further, we also offer a competitive salary, highly competitive benefits package including pension contribution scheme as well as health and life insurance.