Medical Director
2 months ago
Boundless Bio (BBI), Inc. (Nasdaq:BOLD) is a San Diego-based, clinical-stage oncology company dedicated to delivering transformative therapies to patients with previously intractable oncogene amplified cancers. Reporting to the Chief Medical Officer, we are seeking a Medical Director (Senior) who will be an essential contributor to the two clinical development programs with an emphasis on safety, and program-specific and Investigator-related activities. This role will work on cross-functional teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication to internal and external stakeholders.
Essential Duties and 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
Education/Experience:
- 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
- Travel up to 10%
- Open to remote work location
The anticipated annual salary range for this position is $265,000 to $373,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. In addition to base salary, BBI employees are eligible for an annual bonus incentive, and an equity stock option grant. BBI offers a competitive benefits package including, medical, dental, vision, and life insurance for employees and their dependents. We also offer and an Employee Stock Purchase Plan (ESPP) and a 401(k) plan with a matching contribution in addition to a flexible time off policy.
Boundless Bio fosters an inclusive company culture that values diverse talent, backgrounds, and experiences. We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories.
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