Job description
The Role:
The Associate Director, EU Biomarker Strategy and Partnerships will be tasked with project management of clinical phase studies and facilitating operational strategy and innovation across the Moderna’s growing biomarker organization. The candidate will work to develop close -working partnerships with UK scientific experts, NHS and UKHSA biomarker leaders, and biomarker innovators to build the UK/EU Clinical Biomarker ecosystem. In addition, the candidate will be responsible for the project management of different internal teams and external vendors / partners involved in clinical stage studies across Moderna’s portfolio. This includes close collaboration with our UK based Phase I Clinical Biomarker Lab and co-management of our PBMC processing network across the EU. They will work closely with Moderna teams, including: Biomarker Leads, PBMC Steering Committee, Biomarker Program Specialists, Finance, Clinical Operations, Biomarker Operations and Outsourcing stakeholders to ensure that critical timelines are met by our bioanalytical vendors and internal labs and that those timelines accurately capture any program or study level changes.
In addition, the candidate will work side-by-side with the Clinical Development Leadership team to execute on our UK/EU growth strategy both in the short term and long term, including development and management of key partnerships with KOLs and preferred vendors. Guidance from this team will have a direct impact on the future success of Clinical Biomarkers within Moderna. The position requires strong analytical skills, excellent stakeholder communications and relationship building in a complex environment, the ability to translate strategic vision into tactical action, identify the highest impact ideas and plans and focus efforts to work well in a cross-functional team. The ideal candidate will have a background in areas such as: product management, research/commercial operations, finance, or project management, preferably within the life sciences, pharmaceutical, or biotech space.
Here’s What You’ll Do:
Lead within complex, cross-functional initiatives, including driving the problem-solving process and supporting research and analytics, and distilling pragmatic recommendations for management consideration.
Build out and execution of Moderna’s UK and EU organizational strategy, in particular working closely with the UK’s R&D strategy team, to:
Identify key biomarker partners – be these from vendors, clinical or academic sites – to build a strong network for biomarker delivery and innovation
Develop and maintain key partnerships and collaborations with UK/EU based KOLs and preferred vendors
Manage UK/EU Vendor Network and PBMC Processing Network
Collaborate and support Moderna’s UK based Clinical Biomarker Lab
Proactively engage the broader Biomarker team to assess challenges and anticipate business needs to collaboratively strategize and implement concrete action plans to create solutions.
Become a point of contact for vendor engagements and responsible for those engagements
Project Management of multiple vendors for high priority programs across the entire Moderna clinical pipeline
Understand and participate in the strategic selection of key external partners for Biomarker assessment
Be a thought partner to the Biomarker leads to problem-solve, aid in implementing strategies that drive maximum potential realization, and shape the direction of the program.
Drive effective decision-making at the Program and senior leadership level through:
Engagement with key stakeholders, including clinical development teams, data management, statistics, and finance leads
Effective meeting management
Proactively identifying and escalating gaps and challenges along with potential solutions
Manage the biomarker program analyst team through challenging timelines and prioritizations
Proactive communication that is outcome and solution-drive
Liaison with UK Clinical Biomarker Lab and PBMC Steering Committee in the management of PBMC network in EU including:
Oversight of the EU training program and its implementation across the network as well as proficiency testing.
Oversee study start-up to support study usage of PBMC initiative resources (templates, clinical sites, or mobile labs), including during CRO Study Kick-Off, GCL Study Kick-Off(s), and Internal Early Engagement meetings
Understand and participate in the strategic selection of new sites to be added to the PBMC network
Have visibility, bandwidth, and influence to drive completion of all deliverables and key responsibilities, building and leveraging relationships with key stakeholders (team members and leadership) and organizational dynamics to promote program goals.
Here’s What You’ll Bring to the Table:
Bachelor’s degree required, advanced degree (MBA or life sciences MS, Ph.D.) preferred with 8 years of experience in an operational or product management role within a biotechnology or pharmaceutical organization.
Experience with developing and driving operational strategy and innovation to support scale and speed in fast paced organization
Ability to prioritize, manage and drive multiple workstreams involving different key stakeholders.
Effective communication with colleagues of various backgrounds, including scientific, technical, business, and legal staff.
Ability to develop trust with cross-functional stakeholders and influence without authority.
Excellent interpersonal, organizational, and collaborative skills. In addition, attentive to detail, with the ability to work independently and effectively in a fast-paced and highly dynamic environment.
Core project management strengths with tools and best practices for reporting, tracking, data collection, synthesis, budgets, integration, scenario-planning, risk and stakeholder management.
Strong track-record in implementing strategies that drive maximum potential realization
Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally.
Capability building / Change management skills
Highly collaborative, genuinely enjoys working hand-in-hand with internal and external teams to develop solutions that advance Moderna’s overall mission.
Sound business judgment
Experience with tier 1 ERP systems (e.g. SAP, Smartsheet, Oracle) and planning and reporting tools preferred
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
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
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