Manager, Nonclinical Research & Development

The Manager, Nonclinical Research & Development will be responsible for the planning, execution, and management of nonclinical investigations at contract research organizations to support development of Xeris pipeline. Duties of the role include, CRO selection and management, study execution oversight, and reporting results to ensure project milestones and objectives are met, and study deliverables are consistent with program/company goals.

• Establish and manage interactions with CROs and other external partners to generate high-quality data adhering to GLP standards for evaluating Xeris drug candidates in nonclinical pharmacology and toxicology studies in collaboration with the Sr. Director of Nonclinical Research & Development and Product Development Group.
• Review and contribute to study protocols, data analysis, and interpretation of Pharmacokinetic (PK), Toxicokinetic (TK), and Pharmacodynamic (PD) data for nonclinical studies and oversee report generation and approval.
• Prioritize deliverables and ensures goals and objectives are met; collaborate with internal and external team members to facilitate the creation of realistic plans to track operational tasks, timelines, and milestones.  
• Manage budget and accrual tracking of executed Nonclinical investigations.
• Collaborate with Legal and Finance teams on developing and managing study-specific agreements, such as non-disclosure agreements, statements of work, and payment terms; ensure contracts and budgets are developed in accordance with Xeris financial and legal requirements.
• Contribute to department process development, such as developing and writing Standard Operating Procedures (SOPs).
• Maintain a current awareness of evolving technologies and scientific developments that could be applied to advance programs and contribute to diligence efforts
• Present findings and data analysis in internal and external research meetings/conferences.

• A bachelor, master’s, or doctorate in biology, physiology, pharmacology, toxicology, or a related field is required.
• Minimum 0-2 years (doctorate), 3 years (master) or 5 years (bachelor) industry experience in Nonclinical Research & Development required.
• Experience utilizing in vitro and in vivo models for evaluating drug candidates, including evaluating drug delivery technologies and/or routes of administration.
• Knowledge of noncompartmental analysis recommended.
• Must have experience in CRO oversight and vendor management.
• Detailed knowledge of GLP, ICH Guidelines and current US FDA regulations related to nonclinical requirements.
• Experience reviewing or contributing to nonclinical protocols and reports.
• Competencies: Organizational skills, Project Management, Time Management, Functional Leadership, Teamwork & Collaboration, Independent Judgement, Adaptability, Verbal and Written Communication skills.
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Domestic and international travel required, (up to 35%).

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law.  It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.