Vice President and Head, Drug Delivery and Formulation

Omega Therapeutics is a Clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming™ platform. The OMEGA™ 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. Using a suite of technologies, paired with Omega’s process of systemic, rational and integrative drug design, 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 mapped and validated proprietary and novel DNA-sequence-based epigenomic loci, EpiZips™ to durably tune single or multiple genes to treat and cure disease through Precision Genomic Control™. 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 highly innovative and experienced Head of Drug Delivery and Formulation (VP level) to join our growing R&D team.  Reporting to the Chief Scientific Officer, this role will lead the design, development and implementation of novel formulations for Omega’s Epigenomic Programming platform products. They will be responsible for defining strategies, overseeing design and execution of empirical studies, and managing the technical and operational aspects of our drug formulatin and delivery team. They will be an experienced leader with a strong background in LNP formulation discovery, technical development and optimization, including design and screening of lipid nanoparticle (LNP) libraries.  They will provide expertise and leadership to internal and partnered therapeutic programs, and will collaborate with interdisciplinary teams within R&D to develop and manage formulation and delivery strategy, plans, timelines, key deliverables, and reporting to achieve Omega’s company-wide initiatives.

Key Responsibilities:

• Design strategies for developing formulations and drug product, including early process development and scale-up, for preclinical, and clinical studies
• Responsible for developing and executing innovative (LNP and non-LNP) drug delivery strategies, approaches and technologies
• Author and oversee preparation of technical reports, data summaries and formulation-related Nonclinical and CMC-related regulatory submission documents and module sections
• Identify relevant academic and industry collaboration partners, CROs, and state-of-the-art technologies to further develop Omega’s platform and pipeline
• Build and maintain effective partnerships with internal and external key stakeholders and CROs to ensure high quality and on-time execution
• Represent Drug delivery and Formulation function on multidisciplinary project teams, working collaboratively to ensure project progression
• Collaborate in a fast-paced, interdisciplinary team environment with all related and stakeholder functions within drug development (i.e., discovery research, nonclinical development, process and analytical development, regulatory and clinical) to ensure comprehensive assessment of product formulation properties as key aspect of compound optimization and candidate selection
• Work with eary research teams to develop fit-for-purpose early formulations to support in vitro and in vivo (pharmacology, DMPK) studies
• Manage and mentor the growing Formulation and Drug Delivery team, including resource planning, budgets, staff development, and performance management

 Required Skills:

• Demonstrated ability to lead, build and manage an innovative and collaborative team
• Broad experience using a wide variety of formulation concepts across multiple development programs to deliver to a project's Target Product Profile
• A proven track record in designing, screening, optimizing, characterizing and developing lipid nanoparticle (LNP) formulations from preclinical through late-stage clinical development
• Extensive hands-on experience in the development of novel formulation technologies
• Ability to assess the formulation and process technologies landscape to effectively identify and implement enabling formulation technologies or unique delivery systems
• Proficiency with Quality by Design (QbD) concepts and design of experiments (DoE)
• Experience as primary author of relevant sections of INDs and other regulatory documents
• Strong analytical, problem solving and critical thinking skills
• Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform key updates and issues to executive leadership

Required Qualifications:

• Graduate degree in life sciences, chemistry, or related field with 15+ years’ experience in the Biotech/pharma industry (advanced degree preferred)
• A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment
• Experienced leader and scientist with a strong background in discovery and development of novel formulations, including lipid nanoparticles (LNP) vehicles.
• Available to travel if/when needed