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Medical Director Oncology Clinical Development Lead
2 months ago
We are seeking a highly experienced and skilled Medical Director to lead our Oncology Clinical Development Program. As a key member of our team, you will be responsible for overseeing the direction, planning, execution, and interpretation of clinical trials and research activities.
Key Responsibilities- Program Leadership: Manage the design and implementation of clinical development programs, ensuring alignment with overall product development plans and regulatory requirements.
- Study Oversight: Have overall responsibility for the oversight of clinical studies, monitoring study integrity, and reviewing, interpreting, and communicating accumulating data on safety and efficacy.
- Scientific Content Development: Design, analyze, interpret, and report scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and responses.
- Team Management: Oversee the work of Associate Medical and/or Scientific Directors and Clinical Scientists working on the same or related programs.
- Strategic Partnerships: Provide in-house clinical expertise, coordinating scientific and medical activities with internal stakeholders, and participate in due diligence or business development activities.
- Cross-Functional Collaboration: Serve on Integrated Brand Teams and support Integrated Evidence Strategy and Asset Strategy Teams in developing Clinical Development Plans.
- Regulatory Compliance: Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and regulatory requirements.
- Medical Degree: Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.) with relevant therapeutic specialty experience in an academic or hospital environment, Hematology and/or Oncology preferred.
- Clinical Trial Experience: At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Leadership Skills: Ability to run a clinical research program of moderate complexity with minimal supervision and perform and bring out the best in others on a cross-functional global team.
- Communication Skills: Excellent oral and written English communication skills.