Associate Director, Risk Management

The Role:

Join Moderna Therapeutics’ enthusiastic and collaborative team and make a significant impact on the overall success of our novel messenger RNA approach to drug development. By joining our Clinical Safety and Risk Management Team, the Associate Director, Risk Management is responsible for providing Risk Management Plan (RMP) support for Moderna’s investigational and marketed products.

Here’s What You’ll Do:

• Support the global risk management activities for investigational and marketed products throughout the product life cycle including providing support to local and regional teams

• Assist in the development of the core product risk management strategy in collaboration with cross functional stakeholders (e.g., Pharmacovigilance, Epidemiology, Clinical, Regulatory, and Pre-Clinical) including risk characterization, impacts of risks, risk assessment, risk minimization and measurement of the effectiveness of risk minimization activities

• Help oversee the implementation of risk minimization activities in collaboration with relevant key stakeholders

• Contribute to the overall process for Risk Management Plans (e.g., SOPs, WI, templates, tracking) including training

• Assist in setting up risk management planning based on RMP submission requirements communicated by internal and external stakeholders

• Support inspections, audits and quality improvement initiatives related to RMPs

• Interact with regulators or external experts as well as business partners as applicable

• Support RMP training both internally and externally

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

• Degree in Pharmacy, PhD, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background

• Minimum 6 years of pharmacovigilance experience, including experience in supporting RMPs for both investigational and marketed products.

• Knowledge in international RMP regulatory guidelines (e.g: GVP module V, CIOMS IX)

• Technical skills in Document Management Systems and Microsoft Office

• Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

• Excellent time management skills

• Independently motivated, detail oriented and strong problem-solving ability

• Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities

• Excellent written and verbal communication skills with the ability to interact across multiple functions

• Knowledge in global pharmacovigilance regulations

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 home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and minds