Head of Toxicology

Head of Toxicology

Requirements

• 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 managing others on developing toxicology 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.
• Experience with and a passion for people management, team building, and creative solution seeking.
• 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

• In alignment with the corporate mindsets, provide strategic leadership and direction for and build capabilities of the Toxicology team to execute on Moderna’s ambitious and dynamic agenda to deliver transformational medicines and vaccines to patients.
• Apply in-depth knowledge of how toxicology 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 toxicology 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 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 toxicology 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 Toxicology umbrella via collaborative partnerships with study monitors and other partner line program representatives (e.g., pathology, DMPK, bioanalytical, operations, etc.). Accountable for toxicology assessments supporting extractable/leachable and contaminant risk assessments and/or impurity qualification.
• Collaborate closely with and establish positive working relationships with leaders of/colleagues from other nonclinical disciplines (e.g., pathology, DMPK, bioanalytical, therapeutic and infectious disease research, study management & outsourcing, writing, strategic operations) to deliver on integrated nonclinical safety data packages for programs, as well as with clinical development and safety colleagues when interpreting nonclinical data as it pertains to active clinical pipeline programs.
• Provide strategic advice to project teams and senior management including evaluation of conclusions and impact of study results on program and clinical/regulatory strategy.
• 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.
• 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 Toxicology 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.

Preferred Qualifications

• Experience in significantly impacting departmental and organizational initiatives that have shaped research strategies.