Senior Director, Nonclinical Safety Evaluation Job at Moderna (Cambridge)

Job Description

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 Systemic IV portfolio (spanning Autoimmune, Immuno-Oncology, and/or Rare Disease), with additional responsibilities to partner with Platform Science teams to support the safety evaluation and optimization of novel and existing technologies, as well as in other therapeutic areas as needed based on evolving business needs.

Job Responsibility

Provide direct and matrix management of a high performing team of Toxicologists and Pathologists
Provide integrated strategic leadership for Toxicology and Pathology in support of nonclinical safety evaluation
Apply in-depth knowledge of how nonclinical safety disciplines integrate with other areas across the business
Evaluate non-clinical safety challenges in a complex or fast-changing environment and direct the development of new or innovative solutions
Provide strategic oversight on and coach/guide team members on the development of scientifically-sound nonclinical safety strategies
Accountable for the design, execution, critical analysis, and reporting of GLP/non-GLP nonclinical safety in vitro and/or in vivo studies
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
Apply expert scientific and regulatory writing experience when critically reviewing, editing, and authoring submission application documents
Oversee the preparation and presentation of nonclinical safety data for project teams, portfolio management, internal/external partners and/or scientific groups
Maintain extensive scientific awareness and presence internally and externally
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

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs
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
Annual discretionary bonus, other incentive compensation, or equity award

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Senior Director, Nonclinical Safety Evaluation

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