Senior Director, Global Safety Physician – Therapeutics & Oncology

The Role:

Moderna employees currently have the opportunity to directly impact global health through the continued development of mRNA platform technology to address multiple important therapeutic areas with unmet medical need.  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.  To meet our commitment to patient safety as our highest priority we are growing the Clinical Safety and Risk Management team to ensure integrated safety signal identification as well as rapid signal validation/assessment including clinical trial data, post-marketing surveillance, and real-world data integrated with lifecycle risk management planning and feedback to risk minimization activities. 

The Global Safety Physician will have an impact on our rapidly expanding pipeline of systemic secreted and cell surface therapeutics as well as systemic intracellular therapeutics.  This individual will represent the clinical safety and risk management on program teams within the assigned portfolio.

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. 

Here’s What You’ll Do:  

• Provide clinical and scientific leadership for clinical safety issues within cross-functional teams

• Provide broad and comprehensive knowledge of clinical safety

• Direct the resolution of highly complex clinical development / pharmacovigilance topics through the application of advanced critical thinking and communication skills

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

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

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

• Negotiate and successfully influence outside of own functional area 

• Serve as an exemplary leader, mentor, and trainer

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

• MD or non-US equivalent with residency training and board certification (or non-US equivalent)

• Minimum five years’ experience in pharmacovigilance in an industry setting.  Exceptional candidates from academic and regulatory settings will also be considered.

• Prior therapeutic area experience in Oncology required.

• Proven ability to:

  • Collaborate within technical teams to deliver high-quality results within established timelines

  • Utilize technology supporting pharmacovigilance

  • Integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, 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 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 covera