Medical Director

This is an interesting new role for a candidate who likes to become part of an exciting company, someone who is self-motivated and has proven oversight and a pioneering mindset to contribute to the success of an upscaling biotech company. We recently raised $200MIO funding, which allows us to expand the team, therefore a newly created opportunity has occurred for a talented and experienced

 

Medical Director

 

The Medical Director will be part of the clinical development team, providing medical expertise, tactical and strategic input to development plans in a multi-disciplinary team setting to ensure timely planning, designing, conduct, monitoring and reporting of clinical trials in all phases.

The Medical Director will also act as Medical Monitor where they will be part of the clinical development team and serve as the single point of accountability for medical monitoring and oversight of safety for assigned clinical studies (phase 1-3), and providing medical guidance during the design, execution, and reporting for clinical studies in a multi-disciplinary team setting.

 

At Leyden Labs we want to deliver a future without the threat of respiratory viruses by developing accessible, self-administrable products, so people can take control and live their lives to the fullest by protecting themselves against catching infections and preventing transmission to others. We aim for the highest, think unconventionally and focus relentlessly on delivering the impossible. At Leyden Labs we are different, fast, focused.

 

This is what you are going to do for the first 3 to 6 months:

• Set up and execute clinical studies our lead monoclonal antibody
• Design and initiate field efficacy study/ies
• Build relationship with key internal and external stakeholder, subject matter experts and key opinion leaders to facilitate the above goals

 

This is what you’re going to do on a daily basis and these are your responsibilities:

• Responsible for all medical aspects of clinical human trials (phase 1-3) including analysis of medical / clinical development data to support study designs and protocol developments
• Involved in the compilation and assessment of clinical and scientific data generated from Phase 1-3 clinical trials.
• Closely collaborate with multidisciplinary Project Team and Clinical Trial Team members to support the development of drug candidates in all phases of Development
• Provide safety oversight for ongoing clinical trials and in collaboration with the CROs and their medical staff, covering review of individual AEs, SAEs, individual and cumulative safety data, trend analysis and reporting in conjunction with Regulatory Affairs
• Ensure or provide medical evaluation and participates in writing/reviewing key documents including (but not limited to) protocols, informed consent documents, investigator brochures, IFUs, Clinical Study Reports, Annual Reports, PSURs, CERs, publications

 

More about you:

• You obtained a medical degree and have a background in Infectious disease or Immunology (antiviral, antibacterial, biologics drug development experience preferred)
• You have at least 5-8 years of experience
• You have some drug development experience on the sponsor side
• You have experience as a medical monitor at a sponsor or a CRO
• You have experience in clinical study planning and execution

 

Please note that this role could be remote, but you should also be available regularly in the Netherlands.

 

Ideally our new colleague starts as soon as possible. But we are willing to wait for the best candidate, so we understand you have a notice period or already planned your fall leave.

 

We are an equal opportunity employer, and we firmly believe in the added value of a diverse and inclusive group of people with one common goal. We are looking for people who can make an impact and work on a purpose, together.

 

If the purpose of this role and our company ticked all the boxes for your next adventure, please hit the button and let me know you’re interested by sending me a short cover letter and your cv and I will get in touch within 4 working days to plan a first call.

 

Note to all agency recruiters: given the important work our employees do, I kindly request that you do not disturb them by approaching our people directly. I'd love to hear from you at [email protected]