Senior Medical Director

4 weeks ago

Boston, United States Bicara Therapeutics Full time

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.

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