Manager, Biomarker Operations

About the role

Artivabio is seeking a dedicated and experienced Manager of Biomarker Operations to join our innovative team in San Diego, California. This position plays a crucial role in overseeing the development and implementation of biomarker strategies that align with our mission to advance gene therapies. The ideal candidate will possess a robust background in biomarker discovery and validation, as well as a strong understanding of operational management within a biotechnology setting. This is an exciting opportunity to contribute to groundbreaking research and development efforts while leading a talented team.

Key facts

What you'll do

• Lead the biomarker operations team, ensuring effective execution of biomarker strategies that support clinical development programs.
• Collaborate closely with cross-functional teams, including research, clinical, and regulatory, to align biomarker initiatives with overall project goals.
• Develop and implement standard operating procedures (SOPs) for biomarker assays and analyses, ensuring compliance with industry regulations and quality standards.
• Oversee the selection and validation of biomarkers for clinical trials, working with external partners and vendors to ensure timely delivery of results.
• Manage project timelines and budgets, providing regular updates to senior management on progress and challenges.
• Analyze and interpret biomarker data, translating findings into actionable insights for clinical decision-making.
• Foster a culture of continuous improvement within the biomarker operations team, encouraging innovative approaches to problem-solving.
• Mentor and develop team members, providing guidance on technical skills and career development opportunities.
• Coordinate with external laboratories and CROs to ensure high-quality biomarker testing and data generation.
• Prepare and present biomarker data at internal meetings and external conferences, showcasing Artivabio's advancements in gene therapy.
• Stay abreast of industry trends and advancements in biomarker research, integrating new methodologies into the operational framework as appropriate.
• Ensure that all biomarker-related documentation is maintained accurately and is readily accessible for audits and inspections.

Requirements

• A Master's degree or Ph.D. in a relevant scientific discipline, such as molecular biology, biochemistry, or pharmacology.
• A minimum of 5 years of experience in biomarker research or operations within the biotechnology or pharmaceutical industry.
• Proven track record of managing biomarker projects from conception through execution, with a strong understanding of clinical trial processes.
• Familiarity with regulatory requirements related to biomarker testing and clinical development.
• Excellent project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
• Strong analytical skills, with experience in data interpretation and statistical analysis.
• Exceptional communication skills, both verbal and written, with the ability to present complex information clearly to diverse audiences.
• Demonstrated leadership abilities, with experience in managing and developing teams.
• Proficiency in using laboratory information management systems (LIMS) and data analysis software.

Nice to have

• Experience with gene therapy or related fields, particularly in the context of biomarker development.
• Familiarity with bioinformatics tools and techniques for biomarker discovery.
• Previous experience working in a start-up or fast-paced environment.
• Knowledge of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).
• Experience in collaborating with academic institutions or research organizations.

Skills & tools

• Strong leadership and team management skills.
• Proficient in data analysis software and laboratory management systems.
• Excellent organizational and multitasking abilities.
• Strong problem-solving skills and a proactive approach to challenges.
• Ability to work collaboratively in a cross-functional team environment.

Practical notes

• This position is based in San Diego, California, and may require occasional travel for meetings or conferences.
• The company offers a competitive salary and benefits package, including health insurance, retirement plans, and opportunities for professional development.
• Artivabio is committed to fostering a diverse and inclusive workplace and encourages applications from individuals of all backgrounds.

If you are passionate about advancing biomarker operations in the field of gene therapy and are looking for an opportunity to make a significant impact, we invite you to apply for the Manager, Biomarker Operations position at Artivabio. Join us in our mission to transform the future of medicine through innovative therapies.