Sr. Director, Global Safety Physician

Initial Therapeutics, Inc.; Cambridge (MA); On-site; USD 90,000 - 160,000; Full time

Job summary

An established industry player is seeking a passionate clinical leader to drive pharmacovigilance efforts in mRNA therapies. This role offers the opportunity to collaborate with diverse teams and external partners while ensuring patient safety through effective risk management. You will lead safety assessments, engage in regulatory communications, and mentor others in a fast-paced environment. Join a company that values innovation, teamwork, and a culture of belonging, where your contributions directly impact global health and the future of medicine.

Qualifications

• MD or D.O. required with residency training preferred.
• 2-4 years experience in pharmacovigilance in an industry setting.

Responsibilities

• Provide clinical leadership in pharmacovigilance and engage with internal teams.
• Perform case series analysis and lead safety sections of regulatory documents.

Skills

Pharmacovigilance

Clinical Leadership

Communication Skills

Analytical Skills

Problem-Solving

Education

MD or D.O. or non-US equivalent

Residency training & board certification

Tools

Regulatory Reporting Technology

Job description

The Role:

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’s 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.
• Serve as an exemplary leader, mentor, and trainer.

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.
• 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.

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.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office 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.com/careers 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 contact the Accommodations team at [e-mail]. (EEO/AAP Employer)