Associate Scientific Director, Clinical Biomarker

6 months ago

London, United Kingdom Moderna Full time

**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 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.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how

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