Associate Director/Director of Clinical Research

Associate Director/Director of Clinical Research

SAGA Diagnostics is a personalized cancer diagnostics and disease monitoring company focused on molecular genetic analysis of circulating tumor DNA (ctDNA). The company’s mission is to improve precision cancer medicine, provide more accurate treatment monitoring, and improve patient survival using minimally invasive liquid biopsy cancer testing services. SAGA’s proprietary tests can help patients, oncologists, and drug developers detect actionable mutations, stratify patient groups, and monitor treatment response, residual disease, and disease recurrence at unprecedented sensitivity and scale.

SAGA is seeking a talented and highly motivated Associate Director of Clinical Research with a strong interest in advancing our mission to revolutionize cancer diagnostics through the use of liquid biopsies.

You will be a key member of the SAGA clinical development team, an international multi-disciplinary team, where you will be responsible for providing technical and genomic expertise to key clinical studies and biopharma projects. The trials and clinical studies may be either sponsored by SAGA or conducted in collaboration with academic, or commercial partners. We are growing our clinical development team and engaging with world leading KOLs and so this a unique opportunity to build the clinical research, reporting to the VP of Clinical Development.

This is an exciting opportunity to join a rapidly scaling cancer genomics startup with excellent momentum, international attention, and strong customer traction – where every role is critical. Through cooperation and teamwork, you will have the opportunity to help grow the company and make a real difference for people with cancer worldwide.

Key responsibilities:

• Work with external research collaborators from leading academic centers globally to manage relationships, project timelines, sample forecasting and tracking, and data management and analysis for clinical studies.
• Manage proposals from external collaborators through to successful contract execution.
• Act as a point person for an internal clinical team and site staff. Communicate with the larger research and development team regarding research/analysis to ensure understanding of design and results. Provide laboratory expertise to clinical development projects as required.
• Develop clear and measurable analytical plans.
• Interpret individual testing results and provide compilation of all analytical data for finalization and approval prior to clinical study analysis. Utilize primary statistical analysis methods.
• Keep up to date with scientific and academic research data and provide summaries and reviews.
• Provide expertise in cancer genomics for the development of new products.
• Prepare data presentations and publications as required to promote SAGA clinical studies and products. Attend scientific meetings to represent SAGA and support opportunities for abstracts, posters and podium presentation.
• Provide scientific support for biopharma & other business development activity as required.
• Maintain study budget for individual collaborations. Understand, implement and verify complex and tailored study budgets or invoicing for projects.
• Some travel will be required for this position (approximately 10%)

The exact accountabilities and responsibilities will be dependent on the skills and experience of the individual.

Requirements

Technical Requirements:

• PhD or equivalent in Cancer Genomics or similar field.
• Minimum of 5 years’ experience working in a molecular biology environment. .
• Experience of research/clinical trials in the oncology field, would be an advantage.
• Computer literacy (including relevant software, such as Excel, Word, PowerPoint, Adobe plus specific regulatory packages)
• Experience in conducting statistical analysis of genomic datasets is desirable.
• Experience in a Biotech/start-up environment would be advantageous.

Skill Requirements:

• Excellent English oral and written communication skills, including experience in giving presentations.
• Extensive Molecular biology skills.
• Detailed knowledge of Cancer Genomics.
• Knowledge of Product Development would be an advantage.
• Strong troubleshooting and data interpretation skills. Application of statistical principles and analysis skills.
• Experienced in clinical research.
• Strong team working skills with a proven track record of working collaboratively to ensure delivery of projects to meet challenging timelines.
• Flexibility towards work assignments, new learning and travel.

Benefits

Location: Morrisville, NC

Classification: Full Time, Exempt

What we offer:

• The opportunity to build a critical clinical research portfolio from concept and develop exceptional data packages.
• As an early employee of the clinical research team, you will be involved in many aspects of the business and help set the direction/culture as we grow.
• You will be given the autonomy and resources to deliver to the highest level.
• All the perks of a start-up – highly competitive salaries and benefits, flexible working, flat structure, and a dynamic work environment.