Prokarium is recruiting for an experienced Director, Clinical Development to join our diverse and high-performance team. Reporting to the Chief Medical Officer (CMO), you will be a hands-on member of the newly formed clinical development team with an initial focus our lead program, a microbial immunotherapy for the treatment of Non-Muscle Invasive Bladder Cancer. You will drive the creation, implementation and execution of clinical development plans and work with the CMO, VP Research, VP Regulatory, VP CMC and Director of Translational Research on all aspects of clinical development from developing a detailed clinical package and implementing a patient selection strategy through site initiation and management.
Based in central London, you will be a vital part of shaping and executing development plans through early clinical development.
- Contribute, in close collaboration with the CMO, to the scientific and strategic content of our 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 his strategic and more externally facing role
- 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
- With input from Preclinical Research and Translational Research, and external experts, implement biomarker and translational research plans into the Phase 1 study
- Lead site feasibility assessments/visits, if necessary, with CRO, and work closely with CMO to select clinical sites, investigators and CROs/vendors to successfully execute Phase 1 trial within agreed timelines
- Independently coordinate the execution of early clinical studies according to the product development plans, including trial set up, site initiation, recruitment, monitoring, PV, TMF and EDC activities
- Ensure that study conduct adheres to Good Clinical Practices, International Conference of Harmony (ICH) guidelines, and standard operating procedures; working closely with the Director, Quality to setup, review and implement clinical policies and standard operating procedures
- Prepare, together with the CMO, the review and interpretation of clinical trial data to enable timely internal decision-making; including ensuring the accuracy of the clinical study reports and external publications
Qualifications, Experience and Competencies
- 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
- Good social skills and the ability to advise, persuade, and negotiate with colleagues in a supportive and encouraging fashion.
- Excellent written and verbal English communication skills.
- Passion for developing new therapies in a fast-changing SME environment
Desirable experience or know-how
- Experience of interaction with regulators, especially the FDA, MHRA and EMA
- Specific experience developing LBPs or biologics for the treatment of solid tumours (e.g. oncolytic virus development)