Full-Time

Director – Global Safety Physician

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

No salary listed

Senior, Expert

Cambridge, MA, USA + 2 more

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

Hybrid position requiring in-office work 30% of the time.

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Requirements
  • MD, D.O. or non-US equivalent required
  • 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
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 various 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 patients. Unlike traditional pharmaceuticals, which often rely on proteins or antibodies, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to leverage the unique properties of mRNA to improve patient outcomes and create a new category of effective treatments.

Company Size

5,001-10,000

Company Stage

IPO

Headquarters

Cambridge, Massachusetts

Founded

2010

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Simplify's Take

What believers are saying

  • Moderna plans to launch a cancer vaccine with Merck by 2027.
  • The company secured a $590 million contract for bird flu vaccine development.
  • Moderna's mRNA COVID-19 vaccine supply agreement with the EU spans four years.

What critics are saying

  • Moderna faces a high-profile patent lawsuit with Pfizer and BioNTech.
  • The company reported significant net losses in 2024, impacting financial stability.
  • Regulatory scrutiny may delay product approvals, affecting future growth.

What makes Moderna unique

  • Moderna is pioneering mRNA as a new class of medicines.
  • The company focuses on mRNA technology for personalized medicine and vaccines.
  • Moderna's mRNA platform enables rapid development of therapeutics and vaccines.

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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

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

4%
Assure Test
Mar 7th, 2025
Pfizer & BioNTech vs. Moderna: COVID-19 Vaccine Patent Lawsuit

The high-profile lawsuit between Pfizer, BioNTech, and Moderna over mRNA COVID-19 vaccine patents remains one of the most closely watched cases in 2025.

Bloomberg
Mar 5th, 2025
Moderna Eyes 2027 Launch for Cancer Vaccine Developed With Merck

Moderna Inc. expects to launch a personalized cancer vaccine that it's developing with Merck & Co. by 2027, one of its top executives said.

The Wall Street Journal
Feb 27th, 2025
Moderna Shares Fall After Reports of HHS Review of Bird Flu Vaccine Contract

Moderna was awarded the contract from the U.S. Department of Health and Human Services in January during the Biden administration to accelerate development of its mRNA-based vaccine, and as part of an effort to address growing concerns of a bird flu pandemic in humans.

Financial Modeling Prep
Feb 14th, 2025
Moderna, Inc. (NASDAQ:MRNA) Faces Challenges and Opportunities in Biotech Sector

Moderna is developing new products, including a next-generation COVID vaccine, with a revenue forecast between $1.5 billion and $2.5 billion for 2025.

PharmiWeb
Feb 14th, 2025
Moderna Reports Fourth Quarter And Fiscal Year 2024 Financial Results And Provides Business Updates

Reports fourth quarter revenues of $1.0 billion, GAAP net loss of $(1.1) billion and GAAP EPS of $(2.91); loss includes approximately $0.2 billion of non-cash charges related to manufacturing resizingReports full-year revenues of $3.2 billion, GAAP net loss of $(3.6) billion and GAAP diluted EPS of $(9.28)Expects 2025 revenue range of $1.5 to 2.5 billion andending cash balance of approximately $6 billionSubmitted three investigational mRNA products for regulatory approval, including Moderna's next-generation COVID vaccine, RSV vaccine for high-risk adults aged 18 to 59, and flu/COVID combination vaccineCAMBRIDGE, MA / ACCESS Newswire / February 14, 2025 / Moderna, Inc. (NASDAQ:MRNA) today reported financial results and provided business updates for the fourth quarter and fiscal year 2024."We have made progress in 2024 across our late-stage pipeline and cost reduction efforts. Our team successfully filed three Biologics License Applications in the final months of the year and reduced our costs by 27 percent compared to 2023," said Stéphane Bancel, Chief Executive Officer of Moderna. "In 2025, we remain focused on driving sales, delivering up to 10 product approvals through 2027, and expanding cost efficiencies across our business. By the end of 2025, we aim to remove nearly $1 billion in costs. With strong momentum in our late-stage pipeline, we anticipate multiple approvals starting this year, along with key Phase 3 readouts that will support our long-term growth."Recent progress includes:Commercial UpdatesModerna is entering 2025 with two approved products, Spikevax® and mRESVIA®.COVID-19: The Company reported $923 million in Spikevax® sales in the fourth quarter of 2024, which includes $244 million of U.S