To quote Hal Barron (GSK, CSO and ex-Genetech CMO) "The future is cell therapy".
This is exactly what this inspiring biotech is currently doing. Multiple phase I and phase II studies with various molecules make this one of the most exciting companies in Europe right now.
They are developing world-class innovative Cell Therapy medicines (CAR-T and T-Regs) and currently seek a Medical Director of Clinical Development to support their Oncology portfolio.
They are passionate and committed to changing the lives of their patients and by this they are dedicated to advancing their medicines, particularly for the treatment of haematological diseases.
As a Clinical Development / Medical Director you will be responsible for;
- Function as the key member of the clinical study team and lead the medical aspect of the study
- Develop/review/edit essential study documents such as protocols, medical monitoring plan, and medical data reviewing plan, case report forms, database specifications, and statistical analysis plan.
- Provide direct medical input for ongoing clinical trials, including evaluation and interpretation of clinical and laboratory data, assessing safety, making dose escalation decisions, and assessing early pharmacodynamic and clinical signals of activity, all in close collaboration with the clinical team
- Write clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs
- Facilitate the development of key internal and external documents pertaining to product development including clinical study protocol, informed consents, CRFs, CSRs meeting abstracts and presentations, scientific journal publications, strategy documents and clinical/project development
- Perform routine stringent medical data review, approve study enrollment, monitor the safety of the patients enrolled to the study, communicate with the investigators on medical related issues
The ideal Medical Expert will have the following skill set:
- M.D Educated (further education is a plus, not essential)
- 1+ years industry experience working on clinical trials.
- Previous work in Oncology, Haematology and/or Immunology.
- Excellent verbal and written skills
- Previous work with ADR reports, Medical Monitoring, Trial Design and Strategy, Regional or Global trials
- English fluent.
- Able to work in the office.
A Medical Director's Package
- Continue Career support and development.
- Travel expenses and company car.
- Supportive team and highly passionate about curing cancer.
- Gym, child care and relocation support if needed
- Continued career development and opportunities
- Free fruit, tea and coffee.
If interested, please apply via Linkedin or feel free to reach out directly.
Keyword tags
Medical Director - Clinical Development - Medical Expert - Clinical Research Physician - Oncologist - Research Director
Oncology - Haematology - Haem-Oncology - CART - Cell Therapy
Biotech - Pharma
Clinical Research - Clinical Biotech
