Associate Director, Medical Review Physician

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 offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary winter break
• Educational resources
• Savings and investments
• Location-specific perks and extras!
  
  

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

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 .