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Medical Director, Oncology/Hematology Specialist
2 months ago
We are seeking a highly skilled and experienced Medical Director to lead our clinical development efforts. As a key member of our team, you will be responsible for establishing and directing clinical strategies, interacting with senior management and other stakeholders, and ensuring the successful execution of clinical trials.
Key Responsibilities- Lead Clinical Trials: Design, execute, and interpret clinical trials, phases I - IV, for our company's products under development.
- Establish Clinical Strategies: Develop and implement clinical development plans, ensuring alignment with company goals and objectives.
- Manage Clinical Teams: Build and lead high-performing clinical teams, overseeing the work of CROs and other vendors.
- Regulatory Compliance: Ensure adherence to Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) guidelines, aligned with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- Medical Review and Interpretation: Provide medical review, assessment, and interpretation of clinical data, ensuring accuracy and medical interpretation.
- Collaboration and Communication: Work closely with cross-functional teams, including regulatory, process development, and functional group leaders, to advance preclinical programs to clinical evaluation.
- MD Degree or Equivalent: Possess a medical degree or equivalent experience.
- Clinical Trial Experience: Proven experience in clinical trial planning and implementation.
- Regulatory Knowledge: Familiarity with FDA/EMA/PMDA/ or other regulatory agencies interactions.
- Excellent Communication Skills: Possess excellent verbal and written communication skills.
- Leadership and Management: Proven ability to work independently and collaboratively, with strong organizational, time management, communication, and interpersonal skills.
- Cell Therapy Experience: Prior experience in cell therapy products.
- Product Launch Experience: Experience with product launch activities, including authoring of BLA or MAA.
- Knowledge of Current Best Practices: Familiarity with current best practices for potency assays for cellular therapies.
- Competitive Compensation: Comprehensive compensation package, including competitive salary, bonus, and equity.
- Benefits and Perks: Generous paid vacation time, excellent medical, dental, and vision insurance, 401(k) retirement savings plan, and employee stock purchase plan (ESPP).
