Director, Clinical Safety Scientist - Rare & AI
ModernaTX, Inc.

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. Reporting to the Senior Director of Pharmacovigilance, the Director, PV Scientist will be a key contributor and leader focusing on strategic input, support in clinical trial program(s), perform signal management activities, safety and benefit-risk evaluations for assigned products including evaluation of data from multiple sources for safety signals and drafting responses to regulatory inquiries on product safety issues. In this role, the successful candidate will be responsible for leading and overseeing PV activities globally, vendor and alliance management for assigned product group.

Here's What You'll Do:

• Serve as key analytic and safety support lead in close collaboration with the product safety physician/medical monitor
  
• Overseeing and leading aggregate reporting, clinical trial activities, signal management, literature review, and ad hoc regulatory responses for assigned product group
  
• Leads product safety surveillance activities for assigned product(s)during all phases of the product life-cycle
  
  • Review study protocols, statistical analysis plans and other clinical study-related documents
    
  • Review standard design of tables, figures, and listings for safety data from clinical studies
    
  • Manage updates to Investigator Brochure, Company Core Safety Information and other Reference Safety Information
    
• Signal detection, evaluation, and management
  
  • Develop, lead and implement signal detection strategy approved by VP of Pharmacovigilance
    
  • Collaborate with and support study teams and other applicable functional area specialists including (but not limited to) Clinical, Medical, Biostatistics, Medical Affairs, Quality, Regulatory Affairs to identify, evaluate and manage safety signals for Moderna marketed and investigational products to optimally support alignment in the understanding and interpretation of safety data
    
  • Review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
    
  • Prepare review of potential safety signals for the PV Medical Leads and Safety Governance
    
  • Provide safety contents for risk management plans
    
• Assisting in the successful implementation, execution and maintenance of safety processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations
  
• Leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety
  
• Train and mentor junior members of the team
  

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

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background
  
• Minimum 8-10 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 4 years' experience in PV - experience in vaccine development is required
  
• Knowledge of MedDRA terminology and its application
  
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information
  
• Experience in the preparation and authoring of individual and aggregate safety reports
  
• Demonstrated ability to develop, execute and follow-through complex projects to completion
  
• Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  
• 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
  

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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

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.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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