Associate Scientific Director, Clinical Biomarker Laboratory, Immunoassays

Associate Scientific Director, Clinical Biomarker Laboratory, Immunoassays

Moderna

London, United Kingdom

The Role:

Moderna is seeking a talented, experienced, and motivated Associate Director to join the UK Clinical Biomarker Laboratory to serve as a scientific expert and point of contact for the oversight of Immunoassay development, validation, and clinical testing adhering to GCLP (Good Clinical Laboratory Practices) guidelines to support programs across multiple therapeutic areas.

The Associate Director will build a team of scientists for the design and execution of immunoassay assay development, qualification or validation, and the running of clinical samples to return high quality data for clinical trials conducted by Moderna. The candidate will, with support from global and UK operations, assist in the building of a clinical biobanking facility in the UK. The candidate will have a strong and proven background in clinical biomarker assessments by immunoassay in a regulated environment. The candidate will have up to date knowledge and application of best practices in bioanalytical and cell-based assays, with extensive experience in assay validation and executing clinical studies. Experience in acting as a team manager and the ability to effectively communicate across multi-disciplinary teams and external partners is essential. The candidate will be an outstanding scientist, a collaborative team member, and an excellent communicator to support Moderna’s portfolio needs.

The individual will work closely with research associates to develop all bioanalytical and cell-based test methods and characterization tools in support of our clinical phase studies. The position will report to the Director of the Clinical Biomarker Laboratory.

Here’s What You will Do:

• Partner with a team of dedicated laboratory scientists and Clinical Biomarker leads on the science for Moderna’s early and late phase programs;
• Working with the Director of Clinical Biomarker Laboratory UK, you will provide scientific leadership and guide the development and validation of new clinical immuno-assays including ligand binding, ELISA’s, chemiluminescent, flourescent and MSD assays;
• Have deep experience in neutralizing antibody (NAb) assay development and execution. This includes expertise in developing, maintaining, and banking cell lines and expert experience developing and validating cell-based assays;
• Opportunity to build, develop, lead, and train a team of scientists;
• Plan, guide, and oversee activities for assay development, troubleshooting, validation, and ensure clinical testing are met within established timelines;
• Be responsible for delivering robust, high-quality data packages, technical reports including performing quality control on analytical data prior to releasing data to clinical and research teams;
• Ensure culture of quality and continuous improvement. Work with the team to establish new SOPs and streamline documentation procedures. Identify and resolve quality issues, employ mitigation strategies, and escalate issues;
• Ability to maintain clear and efficient documentation in keeping with quality expectations for a regulated laboratory;
• Hold an understanding of wet laboratory workflows and an eye for efficiency and innovation in delivery. Work with the SMEs to implement automation, where appropriate, of assays by incorporating laboratory liquid handling systems and other automation solutions;
• Research scientific and technical literature to propose, test, and implement innovative solutions applicable to the Laboratory;
• Make a scientific impact and help build the UK/EU scientific ecosystem. As a knowledgeable expert in your field, building relationships with other KOLs. Present data at international conferences;
• Hold excellent leadership, attention to detail and communication skills.

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.

Apply Now

More Job Searches

United Kingdom      Clinical Research      Manager and Executive      Pre-clinical Research and Development      Quality Assurance      Moderna