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Job Description
Legend Biotech is seeking a Medical Director to join their Clinical Development team in Somerset, NJ. This role is crucial for the development and life cycle of drug development projects. The Medical Director will provide strategic leadership in developing the Clinical Development Plan (CDP) and collaborate with various departments.
Role involves:
- Developing and implementing the Clinical Development Plan.
- Providing leadership to new product development from IND to submission.
- Managing Clinical Research Scientists.
- Ensuring program consistency and alignment across studies.
- Preparing abstracts, manuscripts, and presentations for external meetings.
- Leading and authoring relevant sections of regulatory documents.
- Overseeing medical review of data and query resolution.
Requirements:
- MD or MD-PhD or equivalent medical degree.
- Oncology/Hematology & CAR-T experience is highly desirable.
- 2+ years of pharmaceutical experience in Clinical Development for Medical Director; 5+ years for Senior Medical Director.
- Experience in leading registrational clinical studies.
- Deep clinical knowledge with medical practice experience.
- Strong skills in scientific analysis and reasoning.
- Solid understanding of clinical development and epidemiology.
- Knowledge of the overall drug development process.
- Prior IND, NDA/BLA experience is highly desirable.
- Strong track record of delivering results through effective team and peer leadership in matrix.
- Excellent leadership, organizational, analytical, and presentation skills.
- Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity (goal setting, performance appraisals, etc.)
Role offers:
- Opportunity to provide strategic leadership in clinical development.
- Chance to work on various indications and phases of clinical studies.
- Collaboration with cross-functional teams.
- Involvement in regulatory interactions.
