Associate Scientific Director, Clinical Biomarker

6 months ago

Oxford, United Kingdom Moderna Full time

**The Role**:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna's strategic partnership with the UK Government is exemplified by our innovative presence at Harwell. Our mission is to establish a leading-edge research development and manufacturing facility, part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic and NHS partners across the UK. We're looking for global experts eager to join us in this endeavor, contributing to a future where access to life-saving vaccines is a reality for all.

Moderna invites a highly skilled Associate Scientific Director to join our Clinical Biomarker Laboratory in Harwell, Oxfordshire, UK. 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 W ill 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 immuno assay validation applicable for intended use of data, e xperience 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 infl

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