Director, Clinical Biomarkers - ID

The Role:

Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID programs.  This position reports to Moderna’s Sr. Director of Infectious Disease, Clinical Biomarkers.  The Director will work collaboratively across multiple clinical teams to ensure strategy, planning, execution and data delivery of biomarker lab data for early and late phase infectious disease vaccine clinical trials conducted by Moderna.

Here’s What You’ll Do:

• Partner with a team of dedicated and senior Clinical Biomarker scientists on the science and bioanalytical assays for Moderna’s early and late phase infectious disease vaccine programs

• Collaborate with clinical and research teams to define overall biomarker strategies for high priority programs

• Oversee biomarker plans and strategy with input from research and clinical leads for ID studies

• Responsible to ensure assay labs complete appropriate development, qualification or validation of biomarker assays in order to execute the clinical biomarker plan on time and with good quality for ID clinical programs

• Ensure timely and efficient delivery of all biomarker operational aspects across multiple ID clinical trials

• Develop and provide operational input and recommendations into all study related documentation (including protocol, lab manual, informed consent form, IB and regulatory filings) and processes, and ensure collection, delivery and analysis of biosamples in compliance with these documents as well as GCP/ICH

• Serve as a primary point of contact for biomarker operations across ID teams, and with external collaborators, assay labs and CROs.

• Contribute to the identification and selection of biomarker vendors and aid in building the strategy for the selection of those vendors

• Serve as the primary point of contact for interpretation and troubleshooting of bioanalytical data for high priority programs

• Lead biomarker sub teams and participate in clinical team meetings

• Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data transfer and collection

Here’s What You’ll Bring to the Table:

• PhD (with at least 4 years pharmaceutical/biotechnology experience) in a related science with a focus on infectious disease.

• Experience leading a team of clinical translational or biomarker leaders and deep understanding of the role of clinical biomarkers across drug development from early phase through licensure

• Deep understanding of the regulatory expectations for pivotal biomarkers in clinical trials

• Solid experience in the application of biomarkers during development of assets required including experience with clinical translational research, development, validation and implementation of biomarkers in the ID space.

• Experience in Infectious disease programs (Ex: Human respiratory viruses / Human herpes viruses / HIV / Human Flaviviruses / Bacterial diseases is highly desirable.

• Experience in Lyme, Pertussis, Group A Streptococcus or other bacterial diseases is a plus.

• Experience in managing third party assay laboratories, collaborations and budget management.

• Strong communication and project management skills

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including h