Director/Sr Director, Clinical Operations
Neoleukin Therapeutics is looking for an experienced, independent leader in clinical operations to join our fast-growing organization. This key position will oversee clinical trials (pre-IND through Phase 1-4) for oncology and autoimmunity contributing to our clinical development program(s). If you are a resourceful, collaborative clinical development expert looking for an opportunity to build something unique, please apply!
- Establish and supervise a team of clinical research professionals, including Clinical Research Associates, Clinical Trial Managers, Documentation Specialists, Biostatisticians, etc.
- Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial execution
- Oversee clinical operations, including study management, budgets and timelines
- Supervise data management, safety management, and study project plans, including communication
- Interface with CROs and clinical site Investigators and staff to ensure optimal site relationships (15% travel expected)
- Review clinical study protocols, informed consent forms, clinical study reports and other clinical documents
- Assist with preparation of pre-IND, IND, BLA and other regulatory filings
- Collaborate with CMC to assist with drug labeling, packaging, storage and distribution for clinical trials
- Serve as monitor or co-monitor for studies, if needed
- Plan and participate in site initiation visits, study meetings, and vendor meetings, as needed
- Master’s degree in a scientific or healthcare discipline preferred
- Minimum of 8 years of experience in clinical drug development in the pharmaceutical/biotech industry required, at least 3 years of early-phase clinical drug development required, and at least 3 years of direct study management work preferred
- Experience in the oversight of all operational aspects of clinical studies required
- Experience managing clinical trials, CROs, multiple vendors, budgets, and timelines
- Experience monitoring clinical studies and conducting site visits, including Site Initiation Visits etc.
- Experience writing clinical protocols, ICF, and CSR required
- Experience in oncology and biologics preferred
- Experience leading a team of collaborative clinical professionals
- Strong leadership skills and self-awareness, with proactive and positive management approach
- Excellent oral, written, and medical communication skills required
- Ability to thrive in a fast-paced and entrepreneurial environment
- Ability to function at a high level in a team setting whether leading the group or contributing independently
- Flexibility to adapt to changing needs in real time
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Excitement about the vision and mission of Neoleukin Therapeutics
Applications can be submitted to firstname.lastname@example.org
Neoleukin Therapeutics is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or age, and Neoleukin will not tolerate discrimination or harassment based on any of the above characteristics.