Full-Time

Director – Global Safety Physician

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines and therapies

Biotechnology
Healthcare

Senior, Expert

Cambridge, MA, USA + 2 more

More locations: Princeton, NJ, USA | Bethesda, MD, USA

70/30 work model requires 70% in-office presence.

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Requirements
  • MD, D.O. or non-US equivalent required
  • Residency training & board certification highly preferred
  • Clinical practice experience highly preferred
  • Prior experience in pharmacovigilance in an industry setting preferred
  • Exceptional candidates from academic, regulatory, and clinical development settings may 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.
Responsibilities
  • Provide clinical and scientific leadership within the pharmacovigilance function.
  • Engage cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs.
  • 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
  • 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

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a molecule that provides instructions for cells to produce proteins essential for various biological functions. Their approach involves creating a new class of medicines that leverage mRNA to potentially enhance the discovery, development, and manufacturing of drugs. Unlike traditional methods, which often rely on proteins or other biological materials, Moderna's use of mRNA allows for a more versatile and efficient way to create treatments. The company's goal is to improve patient outcomes by harnessing the power of mRNA to address a wide range of health issues.

Company Stage

Grant

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

N/A

Growth & Insights
Headcount

6 month growth

3%

1 year growth

12%

2 year growth

54%
Simplify Jobs

Simplify's Take

What believers are saying

  • Moderna's expansion into combination vaccines and autoimmune therapies showcases its potential for diversified revenue streams and market leadership.
  • The company's continuous innovation and FDA approvals for updated COVID-19 vaccines highlight its resilience and adaptability in a rapidly changing market.
  • Moderna's educational initiatives, like the free mRNA course, position it as a thought leader and advocate for mRNA technology.

What critics are saying

  • The collapse in demand for COVID-19 vaccines could significantly impact Moderna's revenue and growth prospects.
  • Ongoing class action lawsuits alleging securities fraud could damage Moderna's reputation and financial stability.

What makes Moderna unique

  • Moderna is pioneering the use of mRNA technology to create a new class of medicines, setting it apart from traditional pharmaceutical companies.
  • The company's focus on mRNA as the 'software of life' allows for rapid development and manufacturing of vaccines and therapies, unlike conventional methods.
  • Moderna's ability to secure regulatory approvals for mRNA vaccines beyond COVID-19, such as for RSV, demonstrates its leadership in mRNA technology.

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