At Arbutus we have a vision: to cure chronic Hepatitis B virus (HBV). We have a dedicated and innovative team and we are uniquely positioned to transform the HBV treatment landscape. We are developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in a combination therapy to cure HBV. Arbutus Biopharma has offices and research facilities in Warminster, Pennsylvania.
We currently have a wonderful opportunity for an Executive Director, Clinical Research at our location in Warminster, PA. Reporting to the Chief Development Officer, the Executive Director, Clinical Research will provide hands-on leadership of Arbutus Biopharma’s clinical research programs and will have overall responsibility for clinical development activities and deliverables.
• Leads and oversees clinical development activities including Phase 1 through 3 leading to product registration, lifecycle management, medical affairs, safety responsibilities, scientific interactions with regulatory bodies and interactions with corporate partner(s);
• Leads and oversees the strategic definition and tactical development of clinical trials programs, including protocol writing, interpretation of clinical data, and literature reviews;
• Ensures that all clinical trials are in keeping with approved timelines and budgets, with potential obstacles identified and solutions implemented to avoid delays in clinical trial implementation;
• Ensures the work with colleagues and collaborators are coordinated and that all people, systems, processes and materials required for clinical trials are available and appropriately prepared;
• Ensures that clinical trials are conducted in accordance with applicable regulatory requirements and guidelines;
• Liaise with clinical investigators and KOL’s to establish sites and monitor progress of trials;
• Analyze clinical data and prepare appropriate reports and papers;
• Attend meetings, present plans and data to regulatory agencies such as the FDA;
• Prepare and write reports required for Regulator Submissions; coordinating with Regulatory Affairs as appropriate;
• Other related duties as assigned.
• MD with minimum 10 years Hepatitis B or C experience and/or antiviral experience, or equivalent combination of education or experience.
• Knowledge of GCP Guidelines and Regulations as they apply in the biotechnology / pharmaceutical industry is essential.
• Pharmaceutical industry experience in the successful development, registration and commercialization of new drug products.
• Strong leadership and team presence with demonstrated effectiveness interacting respectfully, ethically and cross-functionally at all levels both internal and external.
• Ability to travel, up to 25% travel time.
• Excellent written and verbal communication skills as well as outstanding analytical abilities and presentation skills.
• Comfortable working both internally and externally with technical and medical experts in providing input into future drug development strategies.
• Fast learner with ability to deal with technical and business issues with equal skill and able to deal with many ambiguities inherent in an emerging pharmaceutical company without becoming rigid or mechanical;
• Emotional maturity and ability to effectively facilitate change in an environment where the structure may evolve rapidly;
• Familiarity with ICH guidelines and FDA requirements.
**We are not working with agencies or accepting unsolicited resumes.