Senior Director, Nonclinical Safety Evaluation

The Role

At Moderna our mission is to deliver the greatest possible impact to people through mRNA medicines. We foster a dynamic diverse and innovative workplace where every individuals contribution is vital.

We are seeking a seasoned scientific leader to serve in a senior leadership role within Nonclinical Safety Evaluation providing strategic and operational leadership for Toxicology and Pathology. This role will serve on a leadership team with other nonclinical leaders and will partner closely with other cross-functional stakeholders to ensure scientifically rigorous acceptable and compliant nonclinical safety strategies and data packages to support regulatory submissions. This role will have specific emphasis and accountability for products in Modernas emerging and / or established Cancer Antigen Therapy and Infectious Disease portfolios with additional responsibilities in other therapeutic areas as needed based on evolving business needs.

Heres What Youll Do

In alignment with the corporate mindsets provide direct and matrix management of a high performing team of Toxicologists and Pathologists across a range of job levels cultivating a culture of innovation collaboration excellence and continuous learning.

Provide integrated strategic leadership for Toxicology and Pathology in support of nonclinical safety evaluation of products within the assigned therapeutic area(s) from discovery to post-marketing.

Apply in-depth knowledge of how nonclinical safety disciplines (including but not limited to general toxicology safety pharmacology genotoxicity developmental and reproductive toxicology and carcinogenicity) integrate with other areas across the business.

Evaluate nonclinical safety challenges in a complex or fast-changing environment and direct the development of new or innovative solutions with in-depth analysis and interpretive thinking.

Provide strategic oversight on and coach / guide team members on the development of scientifically-sound nonclinical safety strategies to provide expert support to discovery and development projects.

Accountable for the design execution critical analysis and reporting of GLP / non-GLP nonclinical safety in vitro and / or in vivo studies conducted in multiple species under the nonclinical safety assessment umbrella for the assigned therapeutic area(s) via collaborative partnerships with study monitors and program team representatives (e.g. DMPK bioanalytical operations etc.).

May be accountable for toxicology assessments supporting extractable / leachable and contaminant risk assessments and / or impurity qualification.

Serve as a key scientific contributor in regulatory agency interactions internal governance and / or leadership meetings when nonclinical data package conclusions and impact of GLP / non-GLP study results on program and clinical / regulatory strategy are presented.

Apply expert scientific and regulatory writing experience when critically reviewing editing and authoring submission application documents (INDs CTAs BLAs and MAAs) and health authority interaction documents (e.g. briefing documents regulatory query responses) ensuring effective integration of toxicology results with DMPK and pharmacology for the assigned therapeutic area(s). Ensure alignment of toxicology narratives with clinical development plans and regulatory strategies.

Oversee the preparation and presentation of nonclinical safety data for project teams portfolio management internal / external partners and / or scientific groups in a concise and meaningful way.

Maintain extensive scientific awareness and presence internally and externally leading initiatives to publish manuscripts and posters present at scientific conferences and other scientific forums engage with consultants and advisors in the field as well as the scientific community at large.

In addition to providing direct and matrix management the incumbent will also serve as an independent contributor for a select number of discovery and / or pipeline programs as a Toxicology Lead.

Heres What Youll Need (Basic Qualifications)

PhD & 11 or more years spent overseeing aspects of nonclinical safety assessment activities in pharmaceutical development. Strong consideration will be given to those with experience in nucleic acid-based and nanoparticle modalities immune-modulating therapeutics oncology and / or infectious disease vaccine drug development.

Experience serving in and / or managing colleagues serving in the capacity of a Toxicology representative role on drug development programs in the pharmaceutical / biotechnology industry and corresponding experience in designing and executing nonclinical toxicology strategies and GLP / non-GLP studies to support clinical development and regulatory submissions.

Experience in mentoring coaching and / or managing others.

Experience applying regulatory guideline knowledge in the conduct of nonclinical safety studies to support regulatory filings.

Direct experience in writing reviewing and critiquing nonclinical sections of regulatory submission documents (e.g. INDs / CTAs / BLAs / MAAs briefing documents regulatory query responses) and interacting with regulatory agencies.

Passion for people management team building and creative solution seeking for organizational development.

Outstanding written and verbal communication skills and the ability to develop and deliver clear and concise presentations for both internal and external stakeholders.

Attention to detail and quality and ability to deliver work on time.

Demonstrated ability to work successfully in a fast-paced and dynamic work environment with the agility to quickly pivot in the face of new data and / or strategic directions.

A desire to make an impact as part of a high-growth transformational company that is Bold Relentless Curious and Collaborative.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

Best-in-class healthcare coverage plus voluntary benefit programs to support your unique needs

A holistic approach to well-being with access to fitness mindfulness and mental health support

Family planning benefits including fertility adoption and surrogacy support

Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown

Savings and investment opportunities to help you plan for the future

Location-specific perks and extras

The salary range for this role is $196700.00 - $353400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individuals position within the salary range will be based on several factors including but not limited to specific competencies relevant education qualifications certifications experience skills performance and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus other incentive compensation or equity award subject to company plan eligibility criteria and individual performance.

The successful candidate may be eligible for an annual discretionary bonus other incentive compensation or equity award subject to company plan eligibility criteria and individual performance.

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.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Our Working Model

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.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

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 .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements only individuals who qualify as U.S. persons (citizens permanent residents asylees or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

#LI-NH1

Required Experience :

Exec

Key Skills

FDA Regulations,Management Experience,Manufacturing & Controls,Biotechnology,Clinical Development,Clinical Trials,Drug Discovery,Project Management,Filing,Team Management,Leadership Experience,Chemistry

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 196700 - 353400