Senior Medical Director

Algernon Group
Glasgow
8 months ago
Applications closed

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Position Overview:

Our client, a public clinical stage well funded biotech is looking for an EU based Medical Director/Senior Medical Director in Clinical Development who will serve as the Clinical Lead for one or more oncology clinical trials. The Medical Director will work with cross-functional with our US based team and EU sites on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support in-scope aspects of global regulatory interactions.

Responsibilities:

  • Serve as the medical monitor for assigned studies including design, execution and interpretation study data.
  • Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP).
  • Act as liaison between Clinical Development and other internal groups for assigned studies, including working closely with clinical operations, pharmacovigilance, manufacturing, quality and biomarker groups to facilitate and coordinate cross-functional study activities.
  • Provide scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans.
  • Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
  • Serve on cross-functional teams for assigned programs, working with other team members to drive programs and clinical strategy to registration in applicable populations and indications.
  • Establish strong collaborations with study investigators, outside medical experts and represent Bicara during investigator meetings and advisory boards.
  • Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas.
  • Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP).


Qualifications:

  • MD, DO or equivalent ex-US medical degree with 4-6 years of experience in Oncology
  • 2-4 years clinical trial experience, experience with phase 1 trial is a plus.
  • Pharmaceutical/Biotech industry experience in clinical development and medical monitoring.
  • Strong oral and written communication skills.
  • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
  • Ability to work independently to resolve challenges.

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