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Director, Global Safety Physician, Rare Therapeutics
3 months ago
Director, Global Safety Physician, Rare Therapeutics
Apply
locations
Cambridge, Massachusetts
Clinical Development
time type
Full time
posted on
Posted 2 Days Ago
job requisition id
R15548
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 mRNA-based vaccines and therapeutics to benefit patients.
Here's What You'll Do:
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
Here's What You'll Bring to the Table:
MD, D.O. or non-US 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 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.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including:
- Vacation, sick time and holidays
- Volunteer time to participate within your community
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific 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 world-class 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.
to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free 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 proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society.
We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at. (EEO/AAP Employer)
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About Us
Our Mission and Vision
At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA).
This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.
We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.
Our Mission :
To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.
Our Vision :
To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.
Third Party Staffing AgenciesM oderna does not accept unsolicited resumes from any source other than directly from candidates.
For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position.
Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.
Reasonable Accommodation NoticeModerna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws.
Please inform the company's personnel representative by calling or emailingif you need assistance completing any forms or to otherwise participate in the application process.
Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
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