Senior Medical Director

Position Overview:

Our client, a public clinical stage well funded biotech is looking for an EU based Medical Director/Senior Medical Director in Clinical Development who will serve as the Clinical Lead for one or more oncology clinical trials. The Medical Director will work with cross-functional with our US based team and EU sites on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support in-scope aspects of global regulatory interactions.

Responsibilities:

• Serve as the medical monitor for assigned studies including design, execution and interpretation study data.
• Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP).
• Act as liaison between Clinical Development and other internal groups for assigned studies, including working closely with clinical operations, pharmacovigilance, manufacturing, quality and biomarker groups to facilitate and coordinate cross-functional study activities.
• Provide scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans.
• Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
• Serve on cross-functional teams for assigned programs, working with other team members to drive programs and clinical strategy to registration in applicable populations and indications.
• Establish strong collaborations with study investigators, outside medical experts and represent Bicara during investigator meetings and advisory boards.
• Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas.
• Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP).

Qualifications:

• MD, DO or equivalent ex-US medical degree with 4-6 years of experience in Oncology
• 2-4 years clinical trial experience, experience with phase 1 trial is a plus.
• Pharmaceutical/Biotech industry experience in clinical development and medical monitoring.
• Strong oral and written communication skills.
• Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
• Ability to work independently to resolve challenges.