Translational Director - Oncology Clinical Development
Currently a biotech based in Munich with several phase I and II products is looking for an experienced translational expert to help with a number of first in man / phase I studies in 2021.
Their key product is used in precision oncology treatments and has shown strong results against hard to treat / highly resistant cancer types.
Cancer is responsible for millions of deaths each year, and whilst Covid has caused huge disruptions in our lives, Cancer is still responsible for millions more deaths of children and adults. This biotech is using innovative approaches to try and change that.
If you would like to join their mission, to approach cancer in a novel way and work alongside some of the best medical experts and scientists then continue reading.
As a Translational Director (Clinical Development) you will be responsible for;
- Significant work with Translational and Early Development Drug Studies ( I-II ).
- Working with the major German, US and EU regulatory bodies.
- Work with the preclinical science teams and lead identification teams/results for use in candidate validation and entry into clinical studies.
- Lead the development of compound and company strategy with the identification of early opportunities and their participating (including due diligence activities).
- 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 clinical development project lead you will need;
- M.D or can be Ph.D / Msc (and placed as a Clinical Development Director).
- Ideally a 50/50 mix between science background and clinical work
--> Science: Translational, target identification, first in man preperation studies and results.
--> Clinical: Confident in running phase I or II studies.
(If you are not sure - apply anyway and I can speak to you about it)
- Previous work within oncology- either in Solid or Haematological.
- English fluent - essential.
- Able to work in Munich 10 days a month.
- Preferred previous work in the clinics, ideally with cancer patients.
- Proven track record of most of the above job responsibilities or transferrable experiences.
- Competitive salary.
- Flexible working - home office work available.
- Friendly office space, coffee, tea, social events.
- Extensive Oncology and Haematology portfolio to work with including Immunotherapy, CART 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 Translational 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.
- Sharing of the company and confirmation by you to move forward.
- Introductory call with the hiring manager.
- Follow up call with the team (1 or 2 calls).
- Face to face meeting.
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.
Note - I have similar roles open, if this is not 100% right for you (or if you are not sure you are a match) then apply anyway and I can discuss other client opportunities.
Translational Medicine - Translational Director - Clinical Development - Medical Director - Oncology - First in Man - Target Identification - Immuno-Oncology - ImmunoOncology - Oncology - IO - Germany - Munich - Global - Phase I - Phase II - Trial Design - Biotech - Pharma - Drug Development