Associate Director, Medical Review Physician
ModernaTX, Inc.

The Role
The Clinical Safety and Risk Management group within the Clinical Safety and Pharmacovigilance department promotes patient safety throughout the lifecycle of Moderna's product portfolio from first in human through post marketing. As the company and portfolio continue to scale, the in-house medical safety review physician team will be established to ensure the accuracy and completeness of individual case safety reports as well as to conduct timely review of aggregate data in support of causality assessments.

The Medical Safety Review Physician will report to the Director, Lead Medical Safety Review Physician and is responsible for the assessment and medical review of clinical trial adverse event reports, and post marketing reports and for the oversight of external vendors conducting medical review of adverse event reports. This highly collaborative position serves as a medical resource for the global case management team, and other cross-functional teams as needed.

The Medical Safety Review Physician ensures that consistent, timely, and focused medical review for safety cases is conducted according to Moderna defined processes and procedures and according to regulatory and departmental timelines. This position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally.

Duties Include but are not limited to:

• Provide clinical and scientific leadership for medical safety review within the Clinical Safety and Risk Management group.
  
• Participate and collaborate in cross-functional internal workstreams partnering with groups including but not limited to therapeutic area clinical development, biostatistics, clinical operations, medical affairs, and regulatory affairs.
  
• Guide the activities of medical safety review staff from contract research organizations.
  

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:

• Complete assessment and medical review of post-marketing and/or clinical trial individual adverse event reports within regulatory and departmental timelines, including providing the company's causality assessment.
  
• Understand assigned products' pharmacology and chemistry from a safety perspective, relevant nonclinical toxicology and clinical considerations.
  
• Use applicable coding conventions and regulatory requirements, to evaluate all adverse event (AE) reports for "seriousness" and "expectedness", and for medical accuracy and completeness to facilitate regulatory reporting.
  
• Ensure that appropriate medical interpretations are applied to adverse event case assessment.
  
• Ensure accurate coding of adverse events and serving as a resource to the medical coding staff.
  
• Ensure due diligence in characterizing adverse events.
  
• Determine the need for additional follow-up information at the time of individual case review.
  
• Perform company analysis for expedited ICSR and provide alternative etiology as needed.
  
• Ensure timely communication of adverse events of special interest and potential safety signals to product safety lead and/or global safety lead.
  
• Act as a primary medical resource to external vendors to provide physician consultations in ICSR related medical issues.
  
• Apply knowledge of the various regulatory modalities used to detect safety signals in daily activities for assigned products.
  
• Support CFDR (cross functional data review), BLA and other regulatory submissions and other ad hoc reviews as assigned.
  
• Oversee outsourced medical assessment and review activities and provide consultation for medically related questions from participating vendors.
  
• Liaise with program & product physicians/medical monitors to ensure consistency in approach to medical review as well as ensure focused oversight on critical areas related ongoing safety analyses
  
• Monitor global case review activities to ensure adequate timeliness of medical review
  
• Support PV Operations activities during audits and inspections in the areas of medical review and vendor oversight, etc.
  
• Collaborate with the Associate Director of PV Ops ICSR Quality and Analytics supporting the overall performance of the vendor and compliance.
  

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

• MD or international equivalent required.
  
• Clinical experience, minimum of 3 years' experience in a drug safety surveillance setting within the pharmaceutical/biopharmaceutical industry; with both clinical and post-marketing experience in a multi-disciplinary team matrix model - or comparable relevant experience.
  
• Strong written, spoken and presentation communication skills.
  
• Proven ability 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, nongovernmental organizations, and clinical practice groups.
  
• Support establishment of standards, procedures, and process elements for medical review
  
• Thrive in a fast-paced environment while providing appropriate attention to detail.
  
• Excellent analytical, problem-solving, strategic planning, and interpersonal skills.
  

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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