Director Global Safety Physician
Director Global Safety Physician
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Salary Not Disclosed
1 Vacancy
Job Description
The Role
Moderna employees currently 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 mRNAbased vaccines and therapeutics to benefit patients.
Heres What Youll Do:
Provide clinical and scientific leadership within the pharmacovigilance function.
Engage crossfunctional 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 postmarketing surveillance and regulatory reporting as needed
Guide the operations of contract research organizations
Heres What Youll Bring to the Table:
MD D.O. or nonUS equivalent required
Residency training & board certification highly preferred
Clinical practice experience highly preferred
Prior experience in pharmacovigilance in an industry setting preferred
Exceptional candidates from academic regulatory and clinical development settings may also be considered.
Proven ability to:
Collaborate within technical teams to deliver highquality 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 fastpaced environment while providing appropriate attention to detail
Excellent analytical problemsolving strategic planning and interpersonal skills.
At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.
- Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to wellbeing with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your wellbeing journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
- Savings and investment opportunities
- Locationspecific 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 worldclass 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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/careers to learn more about our current opportunities.
Moderna is a smokefree alcoholfree and drugfree 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 committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can 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 . (EEO Employer)
#LIKH1Required Experience:
Exec
Employment Type
Full-Time
