Careers
Head of Clinical Operations
Job Description
Lumen is seeking a highly motivated, 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) and will drive our clinical development program(s).
Essential Duties and Responsibilities
The major tasks for this position are as follows:
- Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial execution
- Interface with CROs and clinical site Investigators and staff to ensure optimal site relationships (15% travel expected)
- Oversee clinical operations, including study management, site selection, budgets and timelines
- Supervise data management, safety management, and study project plans
- Develop or review externally developed 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
- Serve as monitor or co-monitor for studies, if needed
- Plan and participate in site selection, site initiation visits, study meetings, and vendor meetings, as needed
Desired Qualifications & Requirements
Education and Experience Required:
- 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
- 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
- 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
The successful candidate will have the following attributes:
- Strong leadership skills and self-awareness, with proactive and positive management approach
- Excellent oral, written, and medical communication skills
- 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
- Strong attention to detail and organizational skills
- High integrity and ethics
- Commitment to quality and timely delivery of results
Physical Requirements
- Sit for extended periods of time (2 or more hours)
- Occasionally lift or carry up to 20 kg
Application Instructions
Please submit a resume and cover letter to jobs@lumen.bio with the job title in the subject line.
This position is available immediately. Applications will be reviewed upon receipt. Only successful applicants will be contacted.