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Medical Monitor

Brisbane, CA 94005

Posted: 01/24/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 533987 Is job remote?: Yes Country: United States

Job Description

The consultant Medical Monitor within Clinical Development is responsible for medical oversight of clinical development programs and will provide scientific input to clinical protocol development. The Medical Monitor will partner cross-functionally with research, clinical operations, translational sciences, biometrics, pharmacovigilance, and regulatory affairs to manage day to day activities for ongoing clinical studies and collaborate on biomarker and potential companion diagnostic strategies. In addition, the Medical Monitor, Clinical Development will partner with regulatory affairs on preparation for and participation in health authority interactions.  This is a remote working position.

Job Duties
 
  • Provide support in design and execution of Clinical Development strategy in collaboration with internal and external R&D partners, clinical scientists, biometrics, and regulatory affairs
  • Serve as Sponsor medical monitor for assigned clinical trials
  • Partner with safety operations and pharmacovigilance in review of case narratives and other required regulatory documents
  • Partner with Bellicum study management teams to support execution of clinical trials (eg, participate in calls with sites/investigators, SRC meetings, SIVs (as needed)
  • Contribute to the integrated product development plan (PDP) of Bellicum assets
  • Represent clinical development on project teams as assigned
  • Provide input on biomarker strategies and CDx for Bellicum assets
  • Review and/or contribute to authoring (as needed) of briefing books, IBs, DSURs, protocols, and address questions from regulatory authorities and IRBs/IECs
  • Participate in Health Authority (HA) interactions as assigned
  • Represent Bellicum externally at scientific meetings, advisory boards, and through high impact presentations, publications, and other scientific communications
  • Oversee other functions/vendors as assigned
  • Participate in the generation of case report forms for future studies to ensure we are collecting all necessary information in the most appropriate way
  • Understand competitive landscape and provide insights on strategic development pathways
  • Collaborate with the clinical development team on the review, analysis, and interpretation of study results
  • Prepare data and contribute to scientific publications including posters, abstracts and manuscripts
  • Participate in the identification of appropriate external investigators, academic institutions and patient foundations, and develop and cultivate relationships
  • Anticipate potential study problems and prepare contingency plans as needed
  • Provide support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations
  • Proactively seek out and recommend process improvements
  • Communicate clearly and precisely with all levels of the company
  • Provide scientific input to the Translational Sciences team for studies of studies of interest including biomarker development strategies

Skills, Education and Experience Required
 
  • MD or MD, PhD degrees, with at least 8-10 years progressive experience in oncology drug development in the biopharmaceutical/biotech industry
  • Broad knowledge of Oncology; preferred qualification Board certified in Medical Oncology
  • Experience in regulatory filings (MAA, BLA, INDs)
  • Experience in pharmacovigilance, translational medicine/biology, pharmacology or directly related discipline, a plus.
  • Proven experience in Phase I-IV development of hematology/oncology compounds
  • Experienced in planning, control and monitoring of complex and highly visible drug development projects and activities.
  • Strong communication and leadership skills with experience in entrepreneurial, growing organizations
  • Dynamic clinical leader who thrives within a fast paced, growing collaborative and entrepreneurial, and publicly owned, biopharma.
  • Possesses strong scientific and medical understanding in the areas of hematology, oncology, transplants, and cellular immunotherapies.
  • Ability to travel in the U.S. and Internationally
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