Sr. Manager, Signal Management

The Role:

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. Reporting to the Director, Signal Management, the Manager, Signal Management will contribute for all aspects (and be responsible for some aspects) related to the safety surveillance of assigned Moderna product(s) with main focus on conducting the signal management activities (including signal detection, validation, evaluation and tracking) in compliance with worldwide signal management regulations. This Pharmacovigilance Leader will contribute in the building and maintenance of Modernas digital signal detection and management tool, conduct signal detection reviews using innovative signal detection methods, and provide strategic contribution to the data analyses for key-safety focused documents for submission to regulatory agencies (such as safety assessments, PBRER, RMP, DSUR).

This position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. This is an exciting time to join Moderna as we launch our COVID-19 vaccine (mRNA 1273) globally to hundreds of millions of patients and experience acceleration in our pipeline and late phase development, thereby poising Moderna for substantial growth in the upcoming years. This role will be a key contributor and will have the opportunity to make critical contributions to Modernas future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform.

Heres What Youll Do:

• Contribute to providing dynamic strategic contribution to the direction and senior leaders of key pharmacovigilance activities across Modernas portfolio and throughout the clinical development and post-marketing phases of the life cycle including:

  • Contribute to all signal management activities for assigned product(s)

    • Support implantation of signal detection strategy approved by VP of Pharmacovigilance

    • Review adverse event data, literature and other safety-related data for the purpose of signal detection

    • Collaborate with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues to review safety data for signal validation, prioritization, assessment and proposed action plans

  • Collaborate with the Sr Director, Pharmacovigilance Signal Management to oversee Modernas digital signal detection and management tool.

    • Serve as an administrator of the tool

    • Propose and implement signal detection methods in the tool

    • Assist CSRM Moderna staff in using the tool.

    • Contribute to the signal tracking and signal notifications to external stakeholders

    • Contribute to the generation of periodic signal management compliance metrics

  • Provide safety contents for risk management plans and periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues

• Reviews applicable regulatory intelligence on global regulations/guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for signal management.

• Understand relationships and dependencies between signal management and documents/analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other annual reports and/or deliverables

• Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission

• Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents

• Produce high quality, accurate, and fit-for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons

• Review the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with CSRM colleagues

• Draft regulatory response documents such as PRAC assessment reports

• Draft other medical writing deliverables as needed

Heres What Youll 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 4 years experience in Pharmacovigilance

• Excellent written and verbal communication skills with the ability to interpret and present safety data

• Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process

• Knowledge of drug safety/pharmacovigilance practices and tools

• Ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision

• Background in vaccines is a plus

• 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

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!

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 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.

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