Remote Medical Director (Senior)

Summary

Join Boundless Bio as a Medical Director (Senior) to contribute to clinical development programs and work on cross-functional teams for the design, execution, and monitoring of clinical trials.

Requirements

• MD or non-US equivalent, board eligible or certified in Internal Medicine, Oncology, or Hematology/Oncology (minimum completion of a residency program) is strongly preferred
• 3-10 years of biotech or pharmaceutical industry experience as a Medical Director or in a related clinical development function, 2-3 years of small biotech experience preferred, a combination of academia and industry experience may be considered
• Experience in oncology clinical trials required, early development experience (Phase 1 or 2) is preferred
• Experience in solid tumors, small molecules, and biomarker rich precision oncology studies is a plus
• Experience in the design, execution, safety/pharmacovigilance, medical monitoring and reporting of clinical trials in oncology
• Demonstrated ability to evaluate, interpret, and present complex scientific and clinical data
• Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
• Must be able to work independently and thrive in an entrepreneurial, fast paced, and dynamic work environment
• Effective interpersonal and communication skills; must be a collaborative team player with the ability to identify and implement creative solutions to complex technical problems
• Strong learning orientation, curiosity, and passion for science and patients

Responsibilities

• Responsibility for the planning, implementation and daily operation of clinical development programs
• Provides expert input and lead the development of study protocols, all study-related documents, and clinical study reports
• Serve as Medical Monitor responsible for the safety monitoring of clinical studies
• Responsible for responses to investigational study sites for any local ICF changes, protocol & IRB questions/requests
• Responsible for subject eligibility review and for responses to Investigator questions or requests
• Ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, GCP guidelines etc
• Prepare various official and regulatory documents for Regulatory and other agencies, such as INDs, Safety and Annual reports, BLAs, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy)
• Act as clinical expert for assigned studies within and external to Boundless Bio
• Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; respond to or triage questions for appropriate escalation to CMO
• Perform site qualification visits etc
• Lead Investigator, KOL, and advisory team meetings, present at scientific conferences
• Support publication strategy execution including collaboration with Investigators, KOLs, and other internal/external stakeholders
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Annual bonus incentive
• Equity stock option grant
• 401(k) plan with a matching contribution
• Flexible time off policy