Head, Clinical Operations – Rare Disease - Full-time

Head, Clinical Operations – Rare Disease Location: Bedford MA Job Code HCO-0001-18   Homology Medicines is searching for a Sr/Director and Head of Clinical Operations. This person will lead and build a team of Clinical Operations professionals who will oversee the strategy for implementation and the execution of all sponsored clinical trials by Homology Medicines. The ideal candidate will need to have documented experience driving clinical programs across all phases of clinical development. Homology Medicines is focused on the development and commercialization of a highly innovative gene therapy and gene editing technology in rare genetic diseases with unmet medical need. This position will report directly to the VP, Clinical Development and is focused on several areas including, but not limited to, design and implementation of clinical studies in conformance with Good Clinical Practices (GCP) and the International Conference of Harmonization (ICH) Guidelines; building and managing relationships with Contract Research Organizations (CROs); overseeing the creation and implementation of a Clinical Operations team and of standard operating procedures for clinical development; define and implement the overall clinical strategy of Homology Medicines. Essential Functions and Duties Provide leadership in Clinical OperationsWork with the VP, Clinical Development and other clinical function colleagues to design clinical trials and clinical development plans for Homology pipelineBuild Homology Medicines Clinical Operations infrastructureEnsure that staff is properly allocated with appropriate resources to achieve project deliverables and timelinesOversee clinical development budgets and participate in budget reviews and revisions per the needs of the businessSelect and interface directly with CROs, ensuring quality and expectations are metFoster an environment of communication, productivity, creativity and team workActively participate in staff development to include training, performance reviews, mentoring and recruiting Skills and Experience Bachelor's Degree in Life Sciences or equivalent degree. Master's Degree in health-related fields is a plus but not requiredAt least 10-year experience in clinical operations in industry, biotechnology and pharmaceutical companies or contract research organizationsDemonstrated track record of successful drug development and strong experience managing multicenter or global clinical trials from design to clinical study reportProven leadership skills managing cross-functionally in a matrix environmentProven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activitiesCollaborative and flexible in personal interactions at all levels of the companyHave a solid knowledge of Good Clinical Practices (GCP), ICH Guidelines and FDA RegulationsExperience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.Experience in Rare Diseases and/or multiple therapeutic areasExcellent problem solving skills and the ability to adapt to changing priorities and deadlinesExcellent planning, organization and time management skills including the ability to support and prioritize multiple projects.Effective communication and interpersonal skills; effective interaction with senior managementHighest level of scientific integrityExcellent interpersonal, verbal and written communication skills Interested candidates should forward a cover letter and Resume / CV to careers@homologymedicines.com www.homologymedicines.com   Homology Medicines, Inc. (HMI) has built foundational intellectual property on gene editing and gene therapy vectors derived from naturally occurring human adeno-associated viruses (AAVs). The Company's technology is precise, on-target and highly efficient for in vivo editing of genetic mutations. This transformative platform technology, combined with an elite leadership team of biopharmaceutical industry veterans, create a significant opportunity for HMI to rapidly advance a diverse pipeline of new medicines that address and potentially cure the underlying cause of genetic diseases. Life Sciences Job Network. Keywords: Clinical Services Director, Location: Bedford, MA - 01730