Director, Clinical Operations, Clinical Development Operations

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Job description

Omega Therapeutics is a development-stage biotechnology company pioneering a new class of programmable, mRNA-encoded therapeutics to transform human medicine. The OMEGA Epigenomic Programming™ platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. The OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers™, target specific intervention points amongst the thousands of validated novel DNA-sequence-based epigenomic targets we have mapped to tune single or multiple genes to treat and cure disease through Precision Genomic ControlTM. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

About the Role:

Omega Therapeutics, Inc. is seeking a Director, Clinical Development Operations, to join our Clinical team. This role will play a key role in advancing the near-term pipeline and contribute to future programs in various stages of development. The successful candidate will provide operational leadership and expertise in the implementation of clinical development programs. In conjunction with the cross-functional project team, the Director is responsible for overseeing the coordination, management and operational aspects of Clinical Programs to ensure successful completion of projects and ensure delivery of company goals on time, within budget, and in compliance with SOPs, Regulatory Authorities and ICH/GCP guidelines. The position offers the opportunity to interact with all levels of management at Omega, peers and leaders from academic centers involved in key collaborations, external stakeholders in the medical and scientific community, along with global regulatory authorities.

Key Responsibilities:

• Provide operational and implementation expertise to Omega's development teams to enable timely progression of clinical development programs
• Manage and lead direct reports within clinical trial management (Clinical Trial Managers and Clinical Trial Associates)
• Ensure successful enrollment planning, implementation and conduct of all assigned clinical trials
• Assist with the development of the clinical components of regulatory submissions
• Ensure that goals and objectives for clinical development programs are met by providing strategic and tactical input by developing study specific goals, tracking metrics, and producing and presenting summary reports
• Monitors budget for clinical program, and reviews budgets and contracts with CROs, vendors, and investigative sites (as applicable); provides input into contracts, change orders, and/or work orders
• Oversee and approve the development of specific study documents (informed consent forms, study guidelines, operation manuals & training materials)
• Responsible for planning and conducting investigator's meeting
• Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites
• Responsible for the ensuring the integrity and successful transition of the Trial Master File
• Provides input as the subject matter expert for the study during regulatory inspections

Required Skills:

• Demonstrated ability to build mutually respectful relationships with colleagues; trouble shoot challenges and provide direction, guidance, and support to the team to deliver on near term goals
• Strategic and critical thinker, with proven success in managing clinical trials that have supported regulatory filings (experience with regulatory submissions is advantageous)
• Strong communication skills, professional presence, and ability to engage effectively with stakeholders at all levels
• Collaborative and able to motivate and energize cross functional team members to achieve aggressive goals
• Strong problem-solving, and analytical skills, able to facilitate discussions among groups with diverse technical expertise, and progress decisions on complex issues

Required Qualifications:

• Bachelor's degree or nursing qualification in a scientific field of study with 8+ years of relevant experience within pharmaceutical/biotech industry working in Clinical Operations in the Pharmaceutical/Biotech industry or a CRO
• Excellent working knowledge of FDA & ICH/GCP regulations and guidelines and experience in clinical operations groups
• "Hands-on" ability to think strategically and tactically
• Knowledge and experience with managing contracts and budgets (vendor and site) and interfacing with finance group
• Strong knowledge of applicable computer and project management software packages
• Available for up to 25% domestic and/or international travel

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