Medical Director - Oncology Clinical Development Biotech
This biotech currently has a number of Immuno-Oncology focused products in their pipeline at stages I and II. (With a huge amount at IND stage looking to enter into clinics in back end of 2021).
Their key product is used in precision oncology treatments and has shown strong results against hard to treat / highly resistant cancer types.
As a Medical Director ( Clinical Development ) you will be responsible for;
- Significant work with all Development Drug Phases ( I-III ) with a focus in trial design, matrix leadership, regulatory filling and submission preparation and medical expertise to other teams
- Work alongside Medical Monitoring, Clinical Science and Biomarker teams to design Phase I and II studies.
- Support Translational medicine teams for First in Man (IND to Phase I) studies.
- Working with the major German, US and EU regulatory bodies.
- Supporting budget maintenance and allocating funds according to research results, strategy and company decisions.
- With the team select and engage key clinical study sites/centers and establish and maintain collaborative relationships with key investigators.
- Ensure that Clinical Development Standard Operating Procedures (SOPs) facilitate the development of effective clinical study protocols and are compliant.
- 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 input in all essential documents, including, investigator brochure, clinical study reports, IND and NDA summary documents safety annual reports.
- Support clinical research development and implementation of the study protocols, clinical trials and start-ups all within the defined project scope, budget and timeline
- Provide clinical research data to support EMA / FDA and other regulatory bodies and communicate across Medical, Commercial and Quality teams.
As a Medical Director you will need;
- M.D Educated (Note I'm looking for Clinical Development Directors and Scientists too, so if you don't have an M.D I may have other roles open).
- Note: Its not needed to be an oncologist, just a M.D with previous work in oncology.
- Previous work within oncology- either in Solid or Haematological.
- Experience in most of the above responsibilities.
- Working at a Global level supporting various decision makers.
- English fluent - essential.
- Preferred previous work in the clinics, ideally with cancer patients.
- Competitive salary.
- Flexible working - 100% home office or relocation support to office available.
- Friendly office space, coffee, tea, social events.
- Extensive Oncology and Haematology portfolio to work with including Immunotherapy and other scientific approaches.
- Housing and child support if needed. Group pension plan.
- Working with some of the newest oncology treatments in Europe.
- Being lead in an open work culture and under the leadership of 3 highly respected oncologists and industry veterans.
- Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
If you are interested in this mission, or in general would like to discuss your options in the Clinical Development and Medical space then please send your CV in, apply on LinkedIn and contact me. This is what the process will look like (note, this could change depending on you or the client's need);
- Full call with the executive recruiter responsible. (stricly confidential)
- Sharing of the company and confirmation to move forward.
- Introductory call with the hiring manager.
- Follow up call with the team (1 or 2 calls).
My contact details
/ 0044 203 758 8923 /
This will be confidential and your CV will not be shared to anyone without your permission.
Please apply today or reach out confidentially.
Clinical Development - Medical Director - Oncology - CAR-T / CART - Immuno-Oncology - ImmunoOncology - IO - Germany - Munich - Global - Phase I - Phase II - Trial Design - Biotech - Pharma - Drug Development - Home Office - Haematology - Medical Monitoring