Responsible to: Chief
About Cell Medica
is committed to transforming patientsâ€™ lives of patients with cancer through
developing the therapeutic potential of off-the-shelf engineered T cell
focus endeavors to harness the natural biology of a specific subset of
cytotoxic T cells, called Natural Killer T cells (NKT cells).
demonstrate several different important biological differences when compared to
conventional T cells, which we believe render them being particularly suited to
the development of off-the-shelf chimeric antigen receptor therapies (CAR) for
the treatment of patients with both solid and hematological tumors. In addition
to the introduction of a CAR, we have also engineered aspects the resulting
CAR-NKT cells to further optimize their function, potency and therapeutic
innovative CAR-NKT candidates are being developed in collaboration with Baylor
College of Medicine and University of North Carolina, and the first CAR-NKT
product is currently in Phase I clinical trials.
ambition is to develop a growing portfolio of CAR-NKT products to treat broad
populations of patients in need, across multiple highly prevalent tumor types.
is also exploring other innovative preclinical programs in the field of engineered
T cell therapy, based on the innovative Dominant TCR platform technology
developed at University College London, which we hope to progress further over
Reporting to the Chief Medical Officer, the VP of Global
Clinical Development will be responsible for designing and supporting clinical
protocols aligned with the company’s overall development strategy. The position will be based in Houston, Texas,
USA or London, UK.
Develop clinical development/trial strategies,
design study protocols, monitor, document and interpret clinical study data.
Implement safety strategy across studies,
including regular review of efficacy and safety data and response to safety
issues, including communications with investigators and regulatory agencies;
ensure compliance with all pharmacovigilance regulations and guidelines.
Review adverse events, laboratory data, tables,
listings, and graphs; provide medical assessment and instruct staff in
appropriate query and follow up activities.
Participate in the development of clinical
operations standard operating procedures, tools and plans.
Perform medical assessment for expedited safety
reporting, IND and EU annual reports, periodic safety update reports, etc.
Lead medical sections of regulatory documents in
EU and US; assist team with preparations for regulatory agency meetings and
reports, including patient and safety narratives.
Provide medical support and project/therapeutic
training to project and clinical operations team.
Act as medical monitor for relevant clinical
Interface with the project managers to ensure
milestone realization and resource optimization.
Conduct investigator meetings.
Represent Cell Medica in meetings with health
authorities, the scientific community, and international agencies as needed.
Support the publication of clinical data in peer
reviewed journals and presentation at key external scientific
Manage key opinion leaders, protocol steering
committees, safety review committees and advisory boards.
Travel up to 20% of his/her time.
Other duties as assigned by the Chief Medical
Education and Experience
Medical degree with board certification (or
equivalent) in oncology/hematology.
Minimum 3-5 years or equivalent clinical experience
in biopharmaceutical, biotechnology industry.
Experience working within immuno-oncology is
Experience in cellular immunotherapy is
Sound scientific background required to
critically evaluate all scientific aspects of oncology / immunology.
Knowledge of clinical stage drug development
efforts, including typical hurdles and challenges, and experience in mitigation
Experience in designing, monitoring and
implementing clinical trials and interpreting trial results.
Experience interpreting clinical data and
managing safety strategy.
Experience preparing and reviewing documents for
clinical development to ensure high-quality document submissions health
authorities and regulators (knowledge of biomedical research regulation).
Knowledge of assays and metrics for safety,
clinical, and clinical outcomes.
Experience of cross-functional team with diverse
skill sets (matrix organization).
Excellent writing and communication skills,
including oral presentation skills.
Experience in presenting to investors, analysts,
advisory boards, regulatory agencies and corporate governance bodies
Outstanding written and oral communication
Strong scientific understanding of the
therapeutic potential of cellular immunotherapy within the oncology
Highly collaborative and able to build / lead
cohesive, high performing program teams in a matrix environment.
Passion to achieve results with proven ability
to generate high quality, on-time results.
â€œHands-onâ€ leader with â€œcan-doâ€ leadership
Flexible and cooperative spirit with strong
commitment to team efforts.
Strong multi-tasking and prioritization skills.
Comfortable working in highly entrepreneurial
Must be able to remain in a stationary position 90%
Constantly operates a computer and other office
productivity machinery, such as a copy machine and printer.
Fluent verbal and written English language is
essential with an ability to filter and exchange accurate information and
communicate with colleagues.