Medical Monitoring & Oversight Lead

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Medical Monitoring & Oversight Lead

Exciting Medical Monitoring & Oversight Lead position in an innovative biopharmaceutical company

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Nykode Therapeutics is seeking a highly driven Medical Monitoring & Oversight Lead to join the medical team.

As Medical Monitoring & Oversight Lead at Nykode Therapeutics, you will lead the medical monitoring and oversight of clinical trial activities as well as safety, with a primary focus on Oncology.

Your main tasks are:

• Overall responsible for the safety of participants in relevant ongoing clinical trials
• Establishing collaboration and team structure to secure efficient work flow related to medical and safety-related trial activities
• Securing and implementing processes and procedures aligned with Good Clinical Practice (GCP) regulations and company position within pharmacovigilance, medical oversight, and monitoring
• Medical monitoring and causality assessment responsible for the Nykode safety database
• Responsible for operational real-time oversight of relevant pharmacovigilance and medical data input in ongoing clinical trials

Your qualifications include 10 years of experience with clinical research and GCP, including physician experience within oncology. Additionally, you have experience with trial oversight of medical activities and a deep understanding of medical oversight in trial activities. You are well-versed in managing Contract Research Organisations and proficient in overseeing and nurturing relationships with external partners.

You are an MD, preferably with Oncology experience and/or Specialty.

You embrace a forward-thinking mindset prioritising innovative ideas while upholding quality standards, structure, and accuracy. Your work reflects exceptional individual initiative, organisational skills, and drives projects with determination. As an effective communicator and attentive listener, you are masterful in conveying information with clarity and empathy, a cornerstone for establishing trust.

Nykode Therapeutics offers you the opportunity to evolve with a fast-growing, innovative company navigating a dynamic and continuously changing environment. You will have a significant impact on organisational efficacy and the appropriate structuring of workflows.

Nykode is looking for individuals who are inspired by the Nykode technology and the quest to unlock the future of medicine. Nykode is eager to hire people who seek out environments that offer creative challenges and provide growth opportunities.

Travelling: Limited

Domicile: Oslo Norway, or Kongens Lyngby, Denmark

For more details about the job or the company, please contact Director Gert Vium Andersen, Unique Human Capital, on mobile: +45 42 95 08 83. All applications must be in English and are treated confidentially.