Position Overview: The Medical Director/Senior Medical Director in Clinical Development at Bicara Therapeutics will play a pivotal role as the Clinical Lead for multiple oncology clinical trials. This individual will collaborate with cross-functional, multidisciplinary teams to shape clinical development strategies, design and execute clinical trials, provide medical monitoring, and support global regulatory interactions.
Key Responsibilities:
- Leadership in Clinical Development: Lead cross-functional teams, driving program and clinical strategies to achieve registration in targeted populations and indications.
- Medical Monitoring: Oversee the design, execution, and interpretation of study data, ensuring patient safety and adherence to Good Clinical Practices (GCP).
- Document and Analysis Plan Development: Provide scientific and clinical input for study-related documents, including Informed Consent Forms (ICF), Clinical Research Forms (CRF), Statistical Analysis Plans (SAP), and clinical pharmacology and biomarker analysis plans.
- Regulatory Support: Contribute to regulatory submissions by developing clinical sections of INDs and CTAs, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other relevant documents.
- Cross-functional Coordination: Act as a liaison between Clinical Development and other internal departments such as clinical operations, pharmacovigilance, manufacturing, quality, and biomarker groups to ensure seamless coordination of study activities.
- External Collaboration: Build strong relationships with study investigators and external medical experts, representing Bicara Therapeutics at investigator meetings and advisory boards.
- Advisory Board Planning: Assist in the development and planning of Advisory Board meetings in relevant therapeutic areas.
- Strategic Planning: Support the development of the Target Product Profile (TPP) and Clinical Development Plan (CDP).
Qualifications:
- 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 the pharmaceutical or biotech industry, particularly in clinical development and medical monitoring.
- Communication Skills: Excellent oral and written communication skills with the ability to influence and collaborate effectively.
- Collaborative Mindset: Proven ability to work in a fast-paced, team-based matrix environment and function independently as needed.
- Problem-solving Skills: Capability to independently resolve challenges and drive projects to completion.
- Join Bicara Therapeutics and contribute to our mission of advancing oncology treatments through innovative clinical trials and robust clinical development strategies.