- Leadership in Clinical Development: Lead teams to drive program and clinical strategies for registration in targeted populations and indications.
- Medical Monitoring: Supervise study design, execution, and data interpretation to ensure patient safety and compliance with Good Clinical Practices (GCP).
- Document and Analysis Plan Development: Provide scientific and clinical input for various study-related documents.
- Regulatory Support: Contribute to regulatory submissions by developing clinical sections, safety reports, and responses to regulatory authorities.
- Cross-functional Coordination: Liaise between Clinical Development and internal departments to ensure seamless study coordination.
- External Collaboration: Cultivate relationships with study investigators and external experts, representing Bicara Therapeutics at various events.
- Advisory Board Planning: Assist in organizing Advisory Board meetings in relevant therapeutic areas.
- Strategic Planning: Support the development of the Target Product Profile (TPP) and Clinical Development Plan (CDP).
- Educational Background: MD, DO, or equivalent ex-US medical degree.
- Experience: 4-6 years of clinical development experience, including approximately 2 years of clinical trial experience.
- Industry Experience: Previous experience in pharmaceutical or biotech industry.
- Communication Skills: Excellent oral and written communication skills.
- Collaborative Mindset: Ability to work in a fast-paced team environment.
- Problem-solving Skills: Capability to resolve challenges and drive projects to completion.
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Senior Medical Director - Boston, United States - Bicara Therapeutics
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4 weeks ago
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Description
Position Overview: As the Medical Director/Senior Medical Director in Clinical Development at Bicara Therapeutics, you will play a crucial role as the Clinical Lead for several oncology clinical trials. Collaborating with diverse teams, you will shape clinical strategies, oversee trial execution, provide medical monitoring, and assist in global regulatory interactions.
Key Responsibilities:
Qualifications:
Join Bicara Therapeutics and be part of our mission to advance oncology treatments through innovative clinical trials and robust strategies.