External Animal Activities Manager/Senior Manager

Job Description Summary

The role of the Global Risk Review Team (GRRT) Manager/Senior Manager is a business critical position within the Novartis Animal Welfare & Integrity Assurance function responsible for leading the review body that provides ethical oversight of outsourced in vivo activities sponsored by Novartis. This role is essential for ensuring the proper care and welfare of animals enrolled on Novartis studies at external partner sites, that data and trends on animal engagement are monitored and reported as applicable, and that all GRRT processes are compliant with applicable Novartis Corporate Policies and Controls and External Party Risk Management (EPRM) policies and processes. This role is also responsible for day-to-day operations and administration of all oversight programs related to Novartis outsourced in vivo engagements.

#LI-Hybrid

The ideal location for this role is Cambridge, MA but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to Cambridge for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 5-10% travel.

 

Job Description

Key Responsibilities:

Global Risk Review Team Management: Serve as Chair of the Novartis Global Risk Review Team (GRRT) the ethical review body that provides oversight of Novartis External Animal Activities. Manage and adapt GRRT ways of working as business needs and external in vivo environment change. Apply principles of process and operational excellence to GRRT management. Create and implement vision for future use of novel technologies (ex. AI) into program management. Conduct AW assessments, including virtual and physical AW audits, and support oversight needs for large animal (dog, NHP) engagements. Manage protocol review databases and stakeholder communications. Directly perform or oversee post-approval monitoring activities.

GRRT Subteam and NHP Experts Management: oversee and implement administration of both GRRT subteams responsible for reviewing and approving in vivo study protocols. Manage the review queue for the GRRT subteam protocol review process in Jira.

External Party Risk Management: Act as lead AW risk assessor for the Novartis External Party Risk Management (EPRM) system. 

Novartis Creative Marketplace Liaison: Serve as liaison and administrator of AW approvals in research service platforms (ex. scientist.com)

External Animal Activity Data Analysis: Collect raw data related to external animal activities and analyze trends.

Training and Education: Develop and deliver training programs to raise awareness and educate employees conducting Novartis sponsored external in vivo studies on AW processes and requirements. Train staff members on Novartis Animal Welfare Policy and work flows for submitting animal welfare audit requests and external animal study plans for ethical review. Support scientists as a consultant and subject matter expert on animal welfare topics

Stakeholder Management: Interface with key stakeholders within Novartis and at third parties involved in conducting Novartis-sponsored in vivo activities. Stakeholder management will include identifying and following up on concerns, resolving conflicts, fostering positive relationships, and practicing emotional intelligence and resiliency. Use a collaborative approach to research community and laboratory animal care programs to facilitate both scientific studies and animal welfare excellence. 

Innovation in Administration: Use available technologies including AI and automation to efficiently administer all components of the outsourced in vivo program oversight including AW audit related communications, study protocol reviews, scientist.com, EPRM, Jira, and others.

Role Requirements:

• Bachelor’s Degree in a scientific discipline, advanced degree (MS, PhD, DVM) strongly preferred.
• Passion for and understanding of research animal welfare and the 3Rs
• Direct in vivo experience working with large animal species highly desirable
• Experience with preclinical safety assessment studies is a plus.
• Strong knowledge of animal welfare regulations (ex. US, EU) and AAALAC expectations including standards, best practices, and core animal welfare principles.
• Strong experience in conducting vendor due diligence assessments related to animal welfare is a plus.
• Experience managing multiple diverse workstreams using technologies such as: Microsoft 365 suite (Sharepoint, Teams, Copi