Senior Medical Director
7 days ago
We are seeking a highly motivated and experienced Medical Director to support the development of our novel therapeutic candidates in late-stage studies. The successful candidate will have a strong track record of successful drug development and experience in transplant, nephrology, and/or immuno-inflammatory indications.
Key Responsibilities- Design and Execution of Clinical Development Plans: Support the design and execution of clinical development plans for HI-Bio's programs within the transplantation therapeutic area, ensuring alignment with strategic objectives and timelines.
- Medical and Scientific Oversight: Provide medical and scientific oversight for clinical trials, including protocol development, study monitoring, data review, and analysis.
- Clinical Trial Management: Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting.
- Document Development: Draft and coordinate completion of clinical study reports.
- Regulatory Interactions: Prepare responses to questions from Ethics Committees and Health Authorities.
- Integrated Document Development: Support integrated document development for marketing authorization filing.
- Results Interpretation and Reporting: Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions.
- Leadership and Collaboration: Provide leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing, and others.
- Key Opinion Leader and Clinical Investigator Relationships: Establish and maintain relationships with key opinion leaders and clinical investigators in the transplantation field and disease areas related to clinical development programs.
- Regulatory Compliance: Ensure compliance with regulatory requirements and guidelines.
- Cross-Functional Collaboration: Collaborate with cross-functional teams.
- Due Diligence and Business Development: Participate in due diligence activities and provide medical expertise in support of business development initiatives as needed.
- Presentations and External Representation: Present relevant clinical data to internal stakeholders and represent HI-Bio externally at scientific conferences, investor meetings, and other industry events.
- Education and Experience: MD or equivalent degree, with board certification in nephrology, immunology, or similar field. Minimum of 3+ years of clinical development experience in the pharmaceutical or biotechnology industry, with a track record of successful drug development.
- Experience in Late-Stage Drug Development: Experience in late-stage drug development, with a preference for experience in transplant, nephrology, and/or immuno-inflammatory indications.
- Knowledge of Clinical Trial Design and Execution: Strong knowledge of clinical trial design and execution, including experience with adaptive trial designs and biomarker-based approaches.
- Regulatory Knowledge: Deep understanding of regulatory requirements for drug development, including experience leading interactions with global regulatory agencies.
- Interpersonal Skills: Strong interpersonal skills, with the ability to establish and maintain relationships with key opinion leaders, clinical investigators, and internal stakeholders through a highly collaborative approach.
- Travel: Ability to travel domestically and internationally, approximately 10-20% of the time.
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