About Omega Therapeutics:

Omega Therapeutics is a privately held, development-stage biotechnology company leveraging its proprietary epigenomic programming platform to biologically engineer a new class of programmable epigenetic medicines, known as Omega Epigenomic Controllers. Using these epigenomic controllers, Omega is seeking to transform the practice of human medicine through highly selective and direct control of the human genome to treat and cure disease.

Omega Therapeutics leverages its pioneering Epigenomic Programming™ platform to identify novel targets, develop first-in-class programmable epigenetic medicines, and enable rational drug development and manufacturing. Omega examines Insulated Genomic Domains (IGDs), the three-dimensional architecture of the human genome and its accompanying regulators and has identified and classified thousands of genomic “zip codes” across the ~15,000 IGDs as new drug targets. Omega’s new class of medicine, called Omega Epigenomic Controllers™, modulate IGDs using therapeutics that can be programmed to precisely up or down regulate single or multi-gene expression with controlled durability. These epigenomic controllers intervene at the pre-transcriptional level and they function without altering the native human genetic code or nucleic acid sequences. Using a rational and robust target identification and validation process, enhanced by a strong computational and data driven foundation, Omega is able to efficiently design and optimize potential epigenomic controllers from its platform. This entirely new and breakthrough approach allows the Company’s product candidates to also drug previously ‘undruggable’ targets across a broad range of diseases.

The Company is strategically pursuing specific disease targets that have not been successfully addressed through conventional modalities, including certain oncology indications, liver disease, serious inflammatory conditions, and acute respiratory distress syndrome (ARDS) among others. Omega’s mission is to deliver the transformative therapies of tomorrow.

About the Role:

Omega Therapeutics, Inc. is seeking a Director/Associate Director, Supply Chain (commensurate with experience) to join our Technical Operations team.  Reporting to the VP and Head, Technical Operations, this role leads a team responsible for establishing, implementing and managing supply chain activities within the organization and across a network of external vendors used for the clinical supply of Omega’s portfolio of products. This role will drive the activities leading to the implementation of clinical inventory management and distribution systems consistent with meeting cGMP and cGCP, clinical development programs and corporate objectives. He/She will be responsible for the management of vendors including performance metrics and contractual agreements and manage clinical supplies documentation. The Director/Assoc. Director, Supply Chain works with a minimal level of supervision that will support programs and protocols; label creation, labelling activities, shipment and drug return logistical operation by interacting with internal and external customers and suppliers in order to accomplish project objectives.

Key Responsibilities:

  •  Work actively and align with Clinical Operation/Study team to create forecast for each study and program including enrollment rate
  • Support country logistics for shipping and importation
  • Responsible for developing and formalizing robust processes/procedures related to Clinical Supply Chain activities in compliance with global regulations
  • Develop an Inventory strategy per program, study and region
  • Regularly monitor drug expiry and the appropriate inventory re-supply
  • Monitoring of enrolment, drop-out rates and actual supply needs; ensure continuous re-assessment of Project needs
  • Responsible for the sourcing of comparators and matching placebo as needed
  • Design, develop, implement and drive processes for label creation and approvals, including translations for all countries
  • Capable of developing a budget for each study
  • Develop and support a vendor management process including Vendor selection for each program/study, RFP and SOWs with vendors; develop and support the governance process with external vendors
  • Work with vendors to generate inventory reports and regularly review budget and spending
  • Support of regulatory filings including IND submission information
  • Monitor conformance to Clinical Supplies Inventory Management with Interactive Response Technology (IRT) standards
  • Design, implement and oversee return and destruction of IMPs from sites
  • Hire, train, mentor and retain Supply Chain team; plan, direct and monitor work activities such that goals and objectives are accomplished efficiently, completely within established timeframes and compliance

 Required Skills:

  • Complete and advanced understanding cGMP and cGCP requirements for clinical supply chain
  • Strong leadership skills; demonstrated ability to lead a team and influence at all levels of the organization
  • Ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion
  • 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
  • A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment, who communicates effectively with executive leaders and key external partners

Required Qualifications:

  •  Bachelor’s degree in scientific/pharmacy field
  • A minimum 12+ years of leadership experience in Clinical Supply and Supply Chain operations required, along with strong understanding of cGMP and cGCP practices
  • Comprehensive knowledge of IRT design for control of drug distribution and inventory management
  • Knowledge of Import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance
  • Strong understanding for IMP QP requirements
  • Experience in managing third-party clinical supply operations
  • Experience in building and managing inventory management systems
  • Experience in building and managing strong teams
  • Available to travel if/when needed

 

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