Sr. Director – Global Safety Physician
| Company | Moderna |
|---|---|
| Location | Cambridge, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | MD |
| Experience Level | Senior, Expert or higher |
Requirements
- MD, D.O. or non-US equivalent required
- 2-4 years of prior experience in pharmacovigilance in an industry setting, either in a comparable role, or in clinical development
- Proven ability to collaborate effectively within dynamic and fast-moving technical teams to deliver high-quality results within established timelines
- Proven ability to communicate effectively as a teacher
- Proven ability to utilize technology supporting pharmacovigilance (e.g. for signal detection and regulatory reporting)
- Proven ability to 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
- Proven ability to investigate new safety issues
- Proven ability to 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
Preferred Qualifications
- Residency training & board certification highly preferred
- Clinical practice experience highly preferred
- Experience working with public health agencies highly preferred
- Exceptional candidates from academic or regulatory and clinical development settings may also be considered.