Medical Director Oncology

Medical Director - Oncology Clinical Development

The FDA / EMA and people across the world rely on how safe and how robust clinical trials are conducted. Our client is relying on you to help develop their extensive Immuno-oncology platform.

This biotech currently have a number of T-cell response 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. They are using specific antibody approaches and also re-engineered Cell therapy (T-Cell) approaches.

NOTE - It is incredibly rare that I see a biotech with such a strong portfolio offering a 100% home office position. If you are curious (and you fit the requirements) then please reach out - happy to have open discussions about what you are looking for.

As a Medical Director ( Clinical Development ) you will be responsible for;

• Significant work with all Development Drug Phases ( I-III ) with a focus in patient safety, trial design, medical monitoring and documentation.
• Medical Monitoring for their IND to first in man, current phase I and phase II 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
• Previous work within oncology- either in Solid or Haematological.
• Extensive work in Medical Monitoring.
• English fluent - essential.
• Able to travel to key meetings from time to time (3-4 days a month after covid).
• Preferred previous work in the clinics, ideally with cancer patients.
• Proven track record of most of the above job responsibilities or transferrable experiences.

Package:

• 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, 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

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);

1. Full call with the executive recruiter responsible. (strictly confidential)
2. Sharing of the company and confirmation to move forward.
3. Introductory call with the hiring manager.
4. Follow up call with the team (1 or 2 calls).
5. Offer.

My contact details

/ 0044 203 758 8923 /

https://www.linkedin.com/in/charles-spence-epm/

This will be confidential and your CV will not be shared to anyone without your permission.

Please apply today or reach out confidentially.

Keywords

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