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Director, Nonclinical at Peptilogics. . Location: Pittsburgh, Pennsylvania, United States, Remote. About Peptilogics: . Leaders in Scalable, Rational Design. . Peptilogics is a clinical-stage biotechnology company that designs and develops novel peptide therapeutics. The company leverages machine learning, automation, and peptide synthesis to build platforms for science at scale. With its foundations in drug development and engineering, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistry, and molecular biology to advance basic research, target validation, and clinical trials.. Position Overview.  . . The Director, Nonclinical will be responsible for building and leading the nonclinical function to support the advancement of novel therapeutic candidates. This role requires a proactive, execution-oriented leader who can independently drive nonclinical strategy, design, and operations across multiple programs. The ideal candidate is hands-on, highly organized, and thrives in fast-paced, dynamic environments where priorities shift, and cross-functional collaboration is critical. Reporting to senior leadership, the Director will be expected to work with limited oversight while consistently delivering high-quality, phase-appropriate data to inform formulation development, candidate optimization, and regulatory submissions.. . Essential Functions.  . . . Lead strategy, planning, design, and execution of nonclinical activities for antimicrobial peptide-based therapies targeting orthopaedic infections, ensuring regulatory and development alignment. . Own implementation of the nonclinical strategy for a controlled-release injectable to prevent orthopaedic infections; experience with open tibia fractures preferred. . Direct nonclinical efforts to advance an irrigation solution for prosthetic joint infections into registration studies and NDA preparation. . Oversee microbiology, pharmacology, toxicology, efficacy, and safety studies. . Collaborate cross-functionally with clinical, regulatory, and CMC teams to align nonclinical plans with broader development strategies. . Develop and manage nonclinical timelines, budgets, and risk mitigation strategies. . Identify, select, and manage external partners, vendors, and contract organizations supporting nonclinical work. . Manage outsourced studies, including interactions with CROs, academic collaborators, and external partners. . Lead development of phase-appropriate bioanalytical and ADA assays. . Observe preclinical studies to inform model development, formulation testing, and design optimization. . Ensure compliance with GLP, FDA, ICH, and contribute to nonclinical sections of IND submissions. . Provide senior leadership with regular updates on program progress, milestones, risks, and strategic recommendations. . Analyze, interpret, and present nonclinical data to internal and external stakeholders • Plan and lead nonclinical advisory board activities and meetings. . . Additional Duties and Responsibilities.  . . . Support drafting and review of regulatory documents, including briefing books, INDs, and investigator brochures. . Assist with preparation for regulatory interactions related to nonclinical strategy and findings. . Contribute to the design and review of clinical protocols by integrating relevant nonclinical insights. . Collaborate with clinical and regulatory teams. . Regularly assess nonclinical strategy and execution, recommending optimizations and improvements. . Stay current on scientific and regulatory advances in antimicrobial drug development, controlled release technologies, orthopaedic infections, and nonclinical methods. . Foster a culture of accountability, transparency, and continuous improvement across nonclinical functions. . Ensure all tasks and functions are performed safely and in accordance with applicable procedures. . Perform other duties as assigned. . .  . Required Qualifications and Skills.  . . . Bachelor’s or advanced degree in microbiology, pharmacology, toxicology, or a related field. . 10+ years of experience in nonclinical drug development, preferably in antimicrobials or infectious disease. . Background in microbiology, pharmacology, and toxicology; experience with infectious disease models, orthopaedic infections, and/or controlled-release injectables preferred. . Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Project. . Deep understanding of nonclinical development from early proof of concept through NDA, including GLP, GCP, ICH, and other regulatory requirements. . Proven track record managing nonclinical development programs successfully. . Skilled in interpreting complex scientific data, developing strategy, and communicating recommendations clearly. . Comfortable in fast-paced, start-up environments with ability to manage multiple priorities. . Strong leadership, organizational, and problem-solving abilities. . Effective communicator with internal and external stakeholders at all levels. . Our Commitment to Equal Opportunity. . Peptilogics is proud to be an equal opportunity employer. We make hiring decisions based on qualifications, experience, and potential—without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status. We welcome candidates from all backgrounds to apply.