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 - Rare Disease and Autoimmune will have an impact on our rapidly expanding pipeline of systemic secreted and cell surface therapeutics as well as systemic intracellular therapeutics. 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 and will be based in Cambridge, MA.
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:
Here's What You'll Bring to the Table:
- 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
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- 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.
- 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 winter shut down
• 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.