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Sr. Manager, Clinical Safety Scientist

4 months ago

Cambridge, United States Moderna Theraputics Full time

The Role:

Join Moderna Therapeutics' enthusiastic and collaborative team and make a significant impact on the overall success novel messenger RNA approach to drug development. By joining our Clinical Safety Science Team, the Sr. Manager is responsible for performing core pharmacovigilance activities in partnership with the Global Medical Lead by supporting the process for signal management activities and analyses, aggregate report contributions, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial activities.

Here's What You'll Do:

* Provide therapeutic area PV support and representation for Moderna's developmental products in close collaboration PV, Clinical, Regulatory, Data Management and Biostatistics/Programming


* Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents and attend clinical trial meetings


* Carrying out routine pharmacovigilance activities including ongoing signal detection and risk management by conducting aggregate review of Adverse Events/Serious Adverse Events from clinical trials and search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.


* Participate in writing/review of PV input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate



Here's What You'll Bring to the Table:

* Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background


* Minimum 6 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 3 years' experience in PV - experience in vaccine development a plus


* Knowledge of MedDRA terminology and its application


* Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information


* Experience in the preparation and authoring of individual and aggregate safety reports


* Demonstrated ability to develop, execute and follow-through complex projects to completion


* Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view


* 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


* Working knowledge 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 year-end shutdown
* 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

About Moderna

Since 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.

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 modernatx.com/careers 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 apply

Moderna 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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