Clinical Development is one of the most important parts of a growing biotech. It is the difference between helping millions of people on time or making them wait years.
A biotech with 4 Phase I and 3 Phase II Oncology (and Haem-Oncology) pipeline drugs is currently looking to expand their experience Clinical Development team.
They are looking for someone who is mid-level in their career to step into an Associate or Full Medical Director position. The client (and hiring manager) stated "We are looking for someone who understands the requirements in this field but still wanting to learn and develop".
If you have a strong oncology background, understand and have some experience in Clinical Development (can also be Medical Affairs or Clinical Operations) and have a Medical Degree - then I highly recommend we connect.
Below you will find more.
If you are still not sure, feel free to message me directly on (all connections are confidential).
As a Clinical Development expert you will be responsible for;
- Previous work with all Clinical Operations and Development areas ( I-III ) with a focus in patient safety, trial design, site activation and documentation.
- Work with the executive team in shaping and delivering the clinical strategy.
- Responsible for study protocols, understanding their meaning and how to use them, contributing to them and following them.
- Provide medical and data review for the ongoing clinical studies.
- 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 medical 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 equivalent.
- Previous work within oncology- either in Solid or Haematological.
- Work in clinical development (or similar, i.e. Medical Affairs, Clinical Operations)
- Ideally previous Industry experience but CRO, Academic and Hospital research welcome.
- English fluent, French also a highly desirable (but not essential)
- Proven track record of most of the above job responsibilities or transferable experiences.
Package:
- Competitive salary.
- Flexible working (2 days home office, maybe more)
- Friendly office space, coffee, tea, social events.
- Extensive Oncology and Haematology portfolio to work with including Immunotherapy, CART and other scientific approaches.
- Visa support if needed.
- 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
Next steps:
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.
- 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 (can be virtual meeting if needed)
- Offer.
My contact details
/ 0044 203 758 8923 /
https://www.linkedin.com/in/charles-spence-epm/