Sr. Director, Global Safety Physician, Infectious Disease

The Role

Moderna employees currently can directly impact global health through the continued development of mRNA platform technology to address multiple important therapeutic areas with unmet medical needs. The Clinical Safety and Risk Management group supports Moderna’ mission to bring transformative mRNA therapies to patients and its commitment to patient safety through proactive safety assessment, effective risk management, and transparent risk communication throughout the product lifecycle while ensuring the highest standards of quality and compliance.

Moderna seeks candidates aligned with its culture centered on bold, collaborative, curious, and relentless values which enable innovation in mRNA-based vaccines and therapeutics to benefit patients. 

This position supports public health and latent virus vaccines, which are under development to address unmet medical needs of special importance in low and middle income countries, as well as vaccines targeting pathogens that may have long latency prior to disease manifestation

Here’s What You’ll Do:  

• Provide clinical and scientific leadership within the pharmacovigilance function.

• Providing mentoring to junior staff (physicians and scientists), helping them build core skill sets to support clinical safety and pharmacovigilance functions

• Engage cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs.

• Engage with external organizations, key opinion leaders, and consultants/advisors

• Provide clinical input to the design of clinical trials, signal detection and management activities, post authorization studies, risk minimization, and risk communication

• Perform case series analysis of adverse events and review of passive surveillance data mining signals of disproportionate reporting as well as safety issues from other sources

• Lead clinical safety and benefit risk sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees

• Perform post-marketing surveillance and regulatory reporting, as needed

• Guide the operations of contract research organizations as well as individuals hired providing consulting/contractor support

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

• MD, D.O. or non-US equivalent required

• Residency training & board certification highly preferred

• Clinical practice experience highly preferred

• Experience working with public health agencies highly preferred

• 2-4 years of prior experience in pharmacovigilance in an industry setting, either in a comparable role, or in clinical development

• Exceptional candidates from academic or regulatory and clinical development settings may also be considered.

• Proven ability to:

  • Collaborate effectively within dynamic and fast-moving technical teams to deliver high-quality results within established timelines

  • Communicate effectively as a teacher

  • Utilize technology supporting pharmacovigilance (e.g. for signal detection and regulatory reporting)

  • Intepret and integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, government research organizations (e.g. NIH) public health agencies and nongovernmental organizations, and clinical practice groups

  • Investigate new safety issues

  • Communicate medical product benefits and risks to regulatory and public health authorities as well as the public

• Ability to thrive in a fast-paced environment while providing appropriate attention to detail

• Excellent analytical, problem-solving, strategic planning, and interpersonal 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 sa