(Senior) Medical Director
- Experience Level
- Experienced (non-manager)
Title: (Senior) Medical Director
Location: Homebased in Europe
I am currently partnered with an innovative biotech who specialise in sever autoimmune diseases and oncology with a world-class portfolio of novel antibody-based medicines, and due to continued growth, they are now searching for a Medical Director, Haematology to join their team.
This position will provide strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process. This person is responsible for the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable GCP regulations.
- Provides medical content and leadership of the clinical studies
- Medical Monitoring of clinical studies
- Establish and approve scientific methods underlying the design and implementation of clinical protocols
- Ensure study subject safety
- Regularly review adverse event, laboratory and other clinical data, ensure reporting is done on a timely basis
- Collaborate with the study executive and independent safety committee when needed
- Represent clinical research through membership on trial teams.
- Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials
- Interprets, summarizes and documents clinical data for regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
- Collaborate with leading academic medical centres
- Recruit, guide and motivate clinical investigators
- Ensure study compliance by understanding and applying all relevant SOPs and GCPs
- Participate in long range strategic planning
- MD degree, a minimum of 5 years of clinical drug development experience
- Drug Development experience in the area of Haematology
- Desirable: Experience in the therapy areas of (Monoclonal Antibodies) and/or Translational Medicine.
- Able to provide multiple examples of creating and implementing the scientific and clinical principles used for the preparation of clinical studies and clinical trial protocols.
- Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
- Previous experience with regulatory submissions.
- Previous experience with acute myeloid leukemia (AML)
Please apply on LinkedIn or Email your CV to Tamsynne Searle at firstname.lastname@example.org
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