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).

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

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

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.