Join Moderna Therapeutics enthusiastic and collaborative team and make a significant impact on the overall success of our novel messenger RNA approach to drug development. By joining our Clinical Safety and Risk Management Team, the Director, Risk Management Plan is responsible for providing risk management plan expertise for Modernas investigational and marketed products and leads the process for Risk Management Planning.
Heres What Youll Do:
Leads the global risk management activities for investigational and marketed products throughout the product life cycle including providing support to local and regional teams
Coordinates and develops the core product risk management strategy in collaboration with cross functional stakeholders (e.g., Pharmacovigilance, Epidemiology, Clinical, Regulatory, and Pre-Clinical) including risk characterization, impacts of risks, risk assessment, risk minimization and measurement of the effectiveness of risk minimization activities
Oversees the implementation of risk minimization activities in collaboration with relevant key stakeholders
Responsible for the overall process for Risk Management Plans (e.g., SOPs, WI, templates, tracking) including training
Set up risk management planning based on RMP submission requirements communicated by internal and external stakeholders
Subject Matter Expert (SME) on the risk management process for inspections, audits and quality improvement initiatives
Interacts with regulators or external experts as well as business partners as applicable
Responsible for RMP training both internally and externally
Heres What Youll Bring to the Table:
Degree in Pharmacy, PhD, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background
Minimum 8 years pharmacovigilance experience including experience in leading RMPs for both investigational and marketed products.
Expertise in international RMP and risk minimization activities regulatory guidelines (e.g: GVP module V, CIOMS IX, )
Technical skills in Document Management Systems, and Microsoft Office
Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
Excellent time management skills
Independently motivated, detail oriented and strong problem-solving ability
Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities
Excellent written and verbal communication skills with the ability to interact across multiple functions
Knowledge in global pharmacovigilance regulations
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- 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.
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 persons 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.