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Clinical Development Director Oncology
2 months ago
We are seeking a highly skilled and experienced Medical Director to lead our Oncology Clinical Development team. As a key member of our organization, 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 in support of our overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, and emerging issues.
- Study Oversight: Have overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of our molecules.
- Scientific Content: Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and responses.
- Team Management: May oversee the work of Associate Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
- Strategic Partnerships: Provide in-house clinical expertise for our molecules and diseases, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects.
- Regulatory Compliance: Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements.
- Medical Degree: Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree 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.
- Communication Skills: Ability to perform and bring out the best in others on a cross-functional global team.
- Regulatory Knowledge: Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
