Job Title

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 Oncology2-4 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.