Senior Director, Nonclinical Safety Evaluation

Moderna • Cambridge, MA

23d

About The Position

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 individual’s 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 Moderna’s 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. Here’s What You’ll 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.

Requirements

• PhD & 11 or more years spent overseeing aspects of nonclinical safety assessment activities in pharmaceutical 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.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.).
• 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).
• 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.
• Serve as an independent contributor for a select number of discovery and/or pipeline programs as a Toxicology Lead.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree