Senior Director, Global Safety Physician

Moderna Theraputics • Massachusetts, MA

111d • Remote

About The Position

Moderna employees can directly impact global health through the continued development of mRNA platform technology to address multiple important therapeutic areas with unmet medical needs. The Clinical Safety and Risk Management group supports Moderna' mission to bring transformative mRNA therapies to patients and its commitment to patient safety through proactive safety assessment, effective risk management, and transparent risk communication throughout the product lifecycle while ensuring the highest standards of quality and compliance. 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.

Requirements

• MD, D.O. or non-US equivalent required.
• Residency training & board certification highly preferred.
• Clinical practice experience highly preferred.
• Experience working with public health agencies highly preferred.
• 2-4 years of prior experience in pharmacovigilance in an industry setting, either in a comparable role, or in clinical development.
• Exceptional candidates from academic or regulatory and clinical development settings may also be considered.
• Proven ability to collaborate effectively within dynamic and fast-moving technical teams to deliver high-quality results within established timelines.
• Communicate effectively as a teacher.
• Utilize technology supporting pharmacovigilance (e.g. for signal detection and regulatory reporting).
• Interpret and integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, government research organizations (e.g. NIH) public health agencies and nongovernmental organizations, and clinical practice groups.
• Investigate new safety issues.
• Communicate medical product benefits and risks to regulatory and public health authorities as well as the public.
• Ability to thrive in a fast-paced environment while providing appropriate attention to detail.
• Excellent analytical, problem-solving, strategic planning, and interpersonal skills.

Responsibilities

• Provide clinical and scientific leadership within the pharmacovigilance function.
• Engage cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs.
• Engage with external organizations, key opinion leaders, and advisors.
• Provide clinical input to the design of clinical trials, signal detection and management activities, post authorization studies, risk minimization, and risk communication.
• Perform case series analysis of adverse events and review of passive surveillance data mining signals of disproportionate reporting as well as safety issues from other sources.
• Lead clinical safety and benefit risk sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees.
• Perform post-marketing surveillance and regulatory reporting, as needed.
• Guide the operations of contract research organizations.
• Serve as an exemplary leader, mentor and trainer.

Benefits

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs.
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support.
• Lifestyle Spending Accounts to personalize your well-being journey.
• Family planning and adoption benefits.
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment opportunities.
• Location-specific perks and extras.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees