Associate Scientific Director, Clinical Biomarker Laboratory, Immunoassays
Oxford, United Kingdom
In this vital role, you'll be the scientific expert overseeing the development, validation, and clinical testing of immunoassays in accordance with GCLP guidelines. Your leadership will drive the design and execution of assays, contributing significantly to our diverse therapeutic programs.
Within 3 Months you will:
- Initiate and develop strategic partnerships with laboratory scientists, Clinical Biomarker leads, and external partners, aligning your work with Moderna’s early and late phase programs;
- Begin the detailed process of guiding the development and validation of new clinical immunoassays, focusing on a variety of techniques including ligand binding, ELISA’s, chemiluminescent, fluorescent, and MSD assays;
- Commence the recruitment and training of a team of scientists, fostering a collaborative and innovative environment for assay development and qualification;
- Start to immerse yourself in Moderna’s culture and methodologies, gaining a comprehensive understanding of our current immunoassay techniques and protocols.
Within 6 Months you will:
- Take a lead role in the planning, guiding, and oversight of activities for assay development, troubleshooting, and validation, ensuring all processes adhere to GCLP guidelines and are completed within established timelines;
- Deliver robust and high-quality data packages and technical reports, performing quality control on analytical data and ensuring the accuracy and reliability of results prior to their release to clinical and research teams;
- Work towards establishing new Standard Operating Procedures (SOPs) and streamlining existing documentation and workflow procedures, identifying and addressing any quality issues, and implementing effective mitigation strategies;
- Engage in the conceptual stages of building a clinical biobanking facility, leveraging your expertise to assist in the planning and design phases.
Within 12 Months you will:
- Establish a strong culture of quality and continuous improvement within the team, ensuring all operations and developments align with Moderna’s principles and practices;
- Oversee the operational readiness of the clinical biobanking facility, contributing to its implementation and integration within Moderna’s UK operations;
- Make a substantial scientific impact by contributing to the UK/EU scientific ecosystem, establishing relationships with key opinion leaders in the field and presenting data at international conferences;
- Demonstrate effective leadership, attention to detail, and communication skills, becoming an integral part of the site leadership team and influencing the direction of Moderna’s immunoassay research and development.
Here’s What You Will Bring to the Table:
- Ph.D. (immunology or related field) and >6 years or MS (immunology or related field) and >10 years of experience focused on translational medicine preferably infectious disease or oncology;
- Proven expert experience with immunoassay validation applicable for intended use of data, experience with Neutralizing Ab assays preferred;
- Proven record of immunoassay testing in a regulated environment, GCLP, GLP, ISO preferred;
- Ability to maintain a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor, and operational excellence;
- The ability to work in a cross-functional work environment with strong leadership skills and a good balance of creative and analytical skills;
- Understanding of the regulatory expectations for pivotal biomarkers development and validation in clinical trials;
- Excellent written, presentation, and interpersonal communication skills with a proven ability to influence and collaborate in a team environment;
- Proven record of direct management of lab personnel;
- Ability to handle multiple projects concurrently;
- Possess strong computational skills: advanced level use of Excel, Power Point, GraphPad Prism, Word;
- Experience in complex data analysis using analysis software and statistical tools;
- Candidate will be curious in exploring innovative technology, bold in proposing creative experimental designs and ideas. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes.
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