Our UK based biotech client developing microbial cancer immunotherapies requires a Director Clinical Development. Using their leading-edge technology, their mission is to use their expertise in engineering biology and immunology to improve the lives of patients, their lead oncology program is expected to enter the clinic in 2022.
- Contribute, in close collaboration with the CMO, to the scientific and strategic content of oncology products including generation of clinical development plans that provide strategic input into the R&D teams to help prioritise work for speed to clinic
- Function as a clinical development thought-leader inside the company and support the CMO in their strategic and more externally facing role.
- Directly responsible for internal and external members of the clinical development team, including bioanalytics and project management, with ownership of the phase 1 study development
- Responsible for preparation of clinical materials for pre-IND/CTA regulatory discussions and interactions
- Lead the development of clinical documents and reports such as the protocol, investigator brochure, and DSUR
Qualifications and Experience
- PharmD, PhD, MD or equivalent background, proven experience, and preferably a scientific background in Immunology, Oncology or related field
- Minimum 10 years of previous clinical development experience is required (within academia or industry), especially with innovative trial designs (adaptive, platform, basket, combination therapy).
- Mastery of the drug development process (especially early phase clinical trials and preferably with an immunology focus), protocol writing and study conduct, data review and reconciliation.
- Very strong organisational skills and the ability to work well in a dynamic environment and be able to prioritise and respond to changing needs of the business.
- Ability to lead and influence other highly qualified scientists both as line manager and in a matrix structure