Director, Global Safety Physician, Vaccines - Clinical Safety and Risk Management at Moderna Therapeutics in Cambridge, Massachusetts

Job Description:

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 beyond the COVID-19 pandemic. 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, postmarketing surveillance, and real world data integrated with lifecycle risk management planning and feedback to risk minimization activities.

The Global Safety Physician - Vaccines will have an impact on our rapidly expanding pipeline of prophylactic vaccines. This individual will report to the Vice President, Clinical Safety and Risk Management and 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




• 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 and preparation for meetings with regulatory and public health authorities as well as advisory committees




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



• 
  

  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.

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

• On-site subsidized cafeteria or catered lunches


• Company-provided iPhone


• Free parking, monthly subway pass or a subsidized commuter rail pass


• Free annual corporate membership to Bluebikes


• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP


• Flexible Spending Accounts for medical expenses and dependent care expenses


• 16 weeks of 100% paid parental leave for all new parents


• 16 weeks 100% paid family caregiver leave


• 20 weeks 100% paid medical leave


• Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)


• Adoption assistance and discounts to local childcare centers, as well as access to care.com


• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately


• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability


• Voluntary legal assistance plan


• 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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.

-