Medical Director, Clinical Safety Physician
3 weeks ago
Currently our client employees have the opportunity to directly impact global health through COVID-19 vaccine development and post-authorization global administration, and the portfolio is poised to deliver in other important therapeutic areas with unmet medical need. The Clinical Safety group ensures the safety use of our vaccines and therapeutics through continuous assessment of the totality of the available safety data, proactive and effective risk management, and transparent communication of the risks throughout the product life cycle – while ensuring the highest standards of quality and compliance. To meet our commitment to patient safety as our highest priority we are growing our Clinical Safety team to ensure integrated safety signal identification, rapid signal refinement/validation including real world data, and signal evaluation integrated with lifecycle risk management planning and feedback to risk minimization activities.
We are seeking an experienced safety physician who wants to have an impact on our COVID-19 vaccine program and on future programs by supporting our Clinical Safety and Pharmacovigilance efforts. This individual will report to the Clinical Safety Lead and will help drive the medical safety aspects of clinical trial safety evaluation, post marketing surveillance, regulatory reporting, risk management/minimization, and external communication with cross functional partners.
Our client is seeking candidates aligned with its culture centered on bold, collaborative, curious, and relentless values which enable innovation with its vaccines and therapeutics to benefit patients.
JOB RESPONSIBILITIES
Provide clinical and scientific safety expertise and leadership.
Engage cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs.
Manage engagements with external organizations, key opinion leaders, and advisors.
Maintain accountability for case series analysis of adverse events performed by global safety medical directors and pharmacovigilance scientists as well as disposition of passive surveillance data mining alerts and safety issues from other sources.
Lead clinical safety sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees.
Provide clinical and strategic input to the design of clinical trials, signal refinement/validation activities, post authorization studies, risk minimization, and risk communication.
Serve as an exemplary leader, mentor, and trainer.
JOB REQUIREMENTS
MD or non-US equivalent with residency training, board certification, and at least three years of clinical practice experience.
Additional graduate training in public health, epidemiology, or statistics is preferred.
Minimum 3 years’ experience in clinical safety and pharmacovigilance in an industry setting, with experience in vaccine safety preferred. Exceptional candidates from academic, regulatory, and clinical development settings will also be considered.
Proven ability to:
Lead technical teams and 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 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.
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