Head of Nonclinical Safety Evaluation

ModernaTX•Cambridge, MA

15h•$209,000 - $376,000

About The Position

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 individual’s contribution is vital. We are seeking a seasoned scientific leader to serve as the Head of Nonclinical Safety Evaluation, overseeing both Toxicology and Pathology functions. This role will be instrumental in driving nonclinical safety strategies across Moderna’s mRNA pipeline and platform technologies, leading a multidisciplinary team to ensure scientific rigor, regulatory compliance, and an integrated risk assessment for programs from discovery through clinical development. The experienced incumbent will fulfill a key leadership role within our organization, responsible for building team capabilities, overseeing and advancing the Toxicology and Pathology functions and collaborating with leaders from other departments across the Moderna ecosystem to deliver life-changing medicines and vaccines to patients. The incumbent will play a critical role as an enterprise leader, proactively planning for and executing on an organizational design and team structure that enables the team to flexibly support programs across a diverse early- and late-stage pipeline. A track record of superior communication skills, innovative problem-solving skills that navigate complex challenges, and comfort working in a dynamic, fast-paced, cross-functional team environment are required.

Requirements

DVM (ACVP board certification preferred) and/or PhD & 15 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.
A distinguished reputation in the global scientific community as a Toxicology expert.
Experience serving in/managing colleagues serving in the capacity of a Toxicology representative on drug development programs in the pharmaceutical/biotechnology industry and corresponding experience in designing and executing nonclinical toxicology strategies and studies to support clinical development and marketing applications.
Experience in mentoring, coaching, and/or managing others on developing nonclinical safety strategies.
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.
Familiarity with regulatory guidelines for the conduct of nonclinical safety studies to support regulatory filings.
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.
Experience in significantly impacting departmental and organizational initiatives that have shaped research strategies.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Responsibilities

Lead and develop a high-performing team of toxicologists and pathologists, cultivating a culture of innovation, collaboration, and excellence.
Provide integrated strategic direction for the Toxicology and Pathology functions to support nonclinical safety evaluation for all stages of drug development.
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 and utilize business/market expertise to differentiate Moderna from the competition.
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.
Lead and manage a team of toxicologists and pathologists (including but not limited to clinical pathology and/or anatomic pathology subject matter experts) across a range of job levels and experience (may include people leaders), fostering a culture of innovation, collaboration, functional excellence, and continuous learning and development within the team, supporting career growth and professional development opportunities for team members.
In conjunction with platform and pipeline program teams and a cross-functional and integrated Nonclinical Drug Development Sciences team, 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, and critical analysis of nonclinical safety in vitro and/or in vivo studies conducted in multiple species under the nonclinical safety assessment umbrella via collaborative partnerships with study monitors and other partner line program representatives (e.g., DMPK, bioanalytical, operations, etc.).
Accountable for toxicology assessments supporting extractable/leachable and contaminant risk assessments and/or impurity qualification.
Collaborate cross-functionally with research, clinical, DMPK, bioanalytical, operations, clinical development, clinical safety, and regulatory colleagues to ensure holistic safety assessments.
Serve as a key voice in regulatory agency interactions, internal governance and/or leadership meetings when nonclinical data package conclusions and impact of 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) and integrate results with DMPK and pharmacology.
Ensure alignment of toxicology 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 serving as Head of the Nonclinical Safety Evaluation line function, the incumbent may also serve as an independent contributor for a select number of discovery and/or pipeline programs as a Toxicology representative.

Benefits

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

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