Medical Monitor

Reference
JN -072023-130227

 

Oryzon, a public clinical stage biopharmaceutical company developing innovative personalized epigenetic medicines for patients with cancer and CNS disorders, is looking for a Medical Monitor in Oncology.

 

Job Description:

The Medical Monitor collaborates in the overall global (US/EU) clinical development for Oryzon oncology compounds, taking into consideration both medical and scientific issues. She/he is part of a multi-disciplinary, multi-regional, matrix team. The Medical Monitor applies clinical/medical decision making to clinical development issues. This individual interacts with Oryzon senior leadership decision-making for the clinical projects.

 

Must have:

  • MD, DO or internationally recognized equivalent plus 2 years of clinical oncology experience. Hemato-oncology experience is preferable but not mandatory. Biomedical/clinical experience within academia, experience within the pharmaceutical industry, or within a CRO health-related consulting company is desirable.
  • Ability to proactively predict issues and solve problems.
  • Diplomacy and positive influencing abilities.
  • Understanding of Regional/global Regulatory requirements.
  • Good communication/presentation skills.
  • Flexibility and adaptation to demanding timelines.
  • Team oriented person.
  • Fluent in spoken and written English.
  • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.

 

Main activities:

  • Lead the oncology medical monitoring activities with Clinical Development and Operations team.
  • Interpret data from ongoing internal and external studies to assess the medical and scientific implications.
  • Responsible for ongoing safety surveillance from ongoing internal and external studies as well as from publications and systematic review of literature.
  • Accountable for developing/writing Study protocol Synopsis / Protocol, Study Execution, & Study Interpretation.
  • Participates in the preparation / approval of synopses, protocols and the conduct of clinical studies. Accountable for the successful design and interpretation of clinical studies.
  • Train internal and external study teams as applicable in the disease / treatment/ clinical data.
  • Trial Medical Monitoring:
    • Responsible for medical monitoring activities, assessing subject´s eligibility and issues related to protocol conduct and/or individual subject safety.
    • Primary point of contact with investigational sites for medical monitor issues.
    • Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance.
  • Data Management:
    • Responsibility for working closely with Clinical Operations, CROs, other partners and sites to ensure timely and complete collection of data and database for trials.
    • Responsibility for continuous assessment of the quality and the integrity of data from clinical trials.
    • Analyze clinical data with Oryzon scientists and clinicians.
  • Clinical Operations:
    • Work within Oryzon oncology Clinical Operations Group to manage CROs and other contractors.
    • Contribute to the development / writing / review / testing / approval of all the applicable documents or systems governing medical monitoring in a clinical trial or related to medical monitoring activities (as in example eCRF, IWRS, UAT, medical monitor plans).
    • Contribute to the writing / review / approval of key regulatory documents such as IB, DSUR, IND submissions, CAs submissions.
  • External interactions:
    • Serves as medical contact point for medical monitoring of ongoing alliance projects and interface with partner.

 

Location: At Oryzon´s office in Cornellà (Barcelona, Spain)

 

If you see that you meet the requirements, do not hesitate to apply, this is your opportunity.

 

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