Full-Time

Director – Global Safety Physician

Posted on 1/30/2025

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior, Expert

Cambridge, MA, USA + 2 more

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

The position requires 70% in-office work.

Category
Physicians & Surgeons
Medical, Clinical & Veterinary

You match the following Moderna's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
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
  • Proven ability to collaborate within technical teams to deliver high-quality results within established timelines
  • Proven ability to utilize technology supporting pharmacovigilance
  • Proven ability to integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, public health agencies and nongovernmental organizations, and clinical practice groups
  • Proven ability to investigate new safety issues
  • Proven ability to 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
Desired Qualifications
  • 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.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treatment options for various diseases. Unlike traditional pharmaceuticals that often rely on proteins or antibodies, Moderna's mRNA-based therapies can be designed and manufactured more rapidly, allowing for quicker responses to emerging health challenges. The company's goal is to harness the power of mRNA to improve patient outcomes and transform the landscape of medicine.

Company Stage

IPO

Total Funding

$6.5B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

0%

1 year growth

2%

2 year growth

4%
Simplify Jobs

Simplify's Take

What believers are saying

  • Moderna awarded $590 million for bird flu vaccine development.
  • Moderna's mRNA technology expands into oncology and rare diseases.
  • Moderna's EU tender diversifies COVID-19 vaccine supply.

What critics are saying

  • Increased competition from BioNTech and Pfizer in mRNA vaccines.
  • Potential public skepticism reduces COVID-19 vaccine demand.
  • Regulatory challenges in obtaining approvals for new mRNA vaccines.

What makes Moderna unique

  • Moderna is pioneering mRNA as a new class of medicines.
  • Moderna's mRNA platform enables rapid development of vaccines and therapeutics.
  • Moderna's collaboration with AI firms enhances drug discovery processes.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

Sabbatical Leave

Hybrid Work Options

401(k) Company Match

Parental Leave

Family Planning Benefits

Fertility Treatment Support

Adoption Assistance

Wellness Program

Mental Health Support

Phone/Internet Stipend

Home Office Stipend