- Vacation, sick time and holidays
- Volunteer time to participate within your community
- Discretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
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Director, Clinical Safety Scientist - CAMBRIDGE, MA, United States - Moderna Therapeutics
Description
The Role:
Reporting to the Senior Director of Pharmacovigilance, the PV Scientist will be a key contributor focusing on strategic safety input, daily support in clinical trial activities, perform trend analysis for signal management deliverables and safety analytical support for all Moderna products throughout the life-cycle
Here's What You'll Do:
Providing therapeutic area PV support for Moderna's developmental and/or marketed products in close collaboration with senior PV, Clinical and Medical personnel.
Contribute to process improvements that will ensure excellence in global assessment, demonstrating accuracy, consistency and compliance with applicable global pharmacovigilance regulations.
Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents.Represent Pharmacovigilance on global clinical teams and initiatives both within and across functional areas.
Contribute to pharmacovigilance activities including ongoing signal monitoring and regulatory activities.
Facilitate cross-functional Safety Governance meetings, including safety review activities.
Participate in evaluation of potential safety issues in conjunction with senior PV staff, Medical Monitors, and other functional areas as appropriate.
Review and contribute to aggregate safety reports (e.g., DSURs), and Risk Management Plans as required.Participate in writing of safety input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate.
Review of aggregate safety data to ensure accuracy, integrity and completeness.
Analyzing data and drafting documents required for safety for Moderna's investigational productsHere's What You'll Bring to the Table:
Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry backgroundMinimum 8 years relevant medical, scientific/clinical, experience in Biotech, Pharma or a Clinical Research Organization, including at least 4 years' experience in vaccine development PharmacovigilanceKnowledge of MedDRA terminology and its applicationExperience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety informationExperience in the preparation and authoring of individual and aggregate safety reportsDemonstrated ability to develop, execute and follow-through complex projects to completionSkilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of viewIndependently motivated, detail oriented and strong problem-solving abilityExcellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing prioritiesExcellent written and verbal communication skills with the ability to interact across multiple functionsKnowledge of ICH guidelines relevant to PV and of global PV regulations, including FDA, EMA, MHRA, PMDA, and Health Canada.
Strong analytical skills and an ability to synthesize complex issues into consumable, simple messages to faciliate clear, concise and tangible recommendations and/or actions.
Experience working with management and consulting with key business stakeholders (e.g., Clinical, Regulatory, Medical Affairs), including an ability to influence without authority for greater outcomes.
Excellent collaboration and interpersonal skills, an ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.
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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success.
Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow.
If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please applyModerna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.
Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society.
We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at (EEO/AAP Employer) -SummaryLocation: Cambridge, Massachusetts; Clinical DevelopmentType: Full time
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