Moderna Therapeutics

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.

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 medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) 

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