Manager/Sr Manager, Toxicology Operations

POSITION SUMMARY:
Gossamer Bio is seeking an experienced and highly motivated Manager/Sr Manager to join our development team. This individual will manage internal day-to-day operational activities for outsourced non-GLP and GLP toxicology and safety pharmacology studies for several Clinical Stage Programs. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Work directly with members of the Program Teams, including Program Team Leads, Program Managers, and Toxicology Lead to assist in toxicology study preparation, execution and finalization to support clinical program development
• Facilitate CRO vendor selection and oversight, including negotiating contracts and approval; establish consulting agreements with relevant and specialized subject matter experts
• Coordinate CRO contracts Clinical Toxicology by facilitating preparation of statements/scope of work documents, contract approvals, ensuring efficient review of protocols and reports, and driving activities to support program development and regulatory activities.
• Review toxicology study proposals and collaborate with key stakeholders to ensure that they fulfill all requirements of the program development plan
• Assist in the preparation, review, and/or finalization of study protocol and reports
• Coordinate shipping/receipt of test article and study-related samples to appropriate CROs
• Manage study updates, data and documents, and track and maintain study specific milestones
• Apply project management and technical expertise to build and monitor detailed timelines for toxicology and safety pharmacology studies
• Assist in monthly forecasting; participate in quarterly and annual budget planning
• May conduct site visits to monitor critical phases of toxicology studies at CROs
• Participate in the preparation and/or QC of regulatory submissions (INDs, DSURs, IBs, and NDAs)
• Other tasks as assigned
  

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• BS/MS in biological sciences with at least 7 years of related experience. Level will be commensurate with experience.
• Previous toxicology experience in a biotech, pharmaceutical company, or CRO setting preferred
• Experience in outsourcing non-GLP and GLP toxicity studies and interfacing with CROs preferred
• Strong communication (written and oral) and interpersonal skills with an ability to effectively function within a matrix environment
• Familiarity of FDA, EMA, and ICH guidance documents
• Excellent organizational skills and ability to prioritize a diverse workload
• Excellent critical problem-solving ability
• Familiarity with program management software and tools (ie. SmartSheet)
• This position can be Hybrid based out of our San Diego, CA office or Remote.

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.