(Senior) Medical Director

Senior Medical Director - Oncology Clinical Development

Clinical Development is the most important part of a growing biotech. It is the difference between helping millions of people on time or making them wait years.

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.

They currently have a number of T-cell response focused products in their pipeline including CART which is in early phase I.

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 with some being very difficult to treat - 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 Senior Medical Director of 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.
• Working with the major Asian regulatory bodies and championing the company across the Asian region.
• Responsible for 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 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.
• Ideally previous work in Asian markets / studies (not essential).
• Extensive work in clinical development and trial design.
• English fluent - essential.
• Mandarin speaking - preferred but not ideal.
• 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 - 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

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.
2. Sharing of the company and confirmation by you to move forward.
3. Introductory call with the hiring manager.
4. Follow up call with the team (1 or 2 calls).
5. Face to face meeting.
6. 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 - Singapore - Global - Phase I