Company Overview
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Summary:
The Associate Director of Operational Excellence is responsible for focusing on optimizing and improving the efficiency and effectiveness of clinical trial operations. The role involves leading and implementing strategies for continuous improvement, ensuring compliance with regulations, and leveraging data analytics to enhance study execution. This role will focus on process, inspection readiness and clinical operations capability builds.
Responsibilities:
- Strong understanding of clinical trial processes, regulations and best practices
- Deliver measurable results by analyzing data and identifying trends, patterns and areas for improvement
- Identify areas for improvement in clinical trial processes, develop and implement new strategies, and ensure adherence to best practices to enhance operational efficiency and effectiveness
- Oversee the quality control of clinical trials, ensuring adherence to GCP and other regulations in support of inspection readiness activities
- Collaborate with cross-functional teams, including Regulatory, Quality, and IT as the Clinical Operations Subject Matter Expert to update processes and support clinical operation capability builds
- Oversight of study level and department level training matrices
- Have the skillset and experience to lead and manage cross-functional teams to implement operational excellence initiatives that align with corporate goals/objectives
- Lead and mentor teams, fostering a culture of continuous improvement and professional development
- Assist teams with Veeva platform systems such as Trial Master File, Study Learning and Quality Management.
Qualifications:
- Bachelor’s Degree in a related field with 8+ years experience in the biotech and/or pharmaceutical industries in the clinical trial and/or GCP quality space
- Required skills:
- Leadership
- Analytical
- Problem-solving
- Project management
- Thorough understanding of GCP/ICH Guidelines, as well as strong understanding of cross-functional clinical processes
- Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning
- Excellent communication (written and verbal), presentation, and interpersonal skills
