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Senior Program Manager, CMC, BLA

3 months ago

Cambridge, United States MEDIPOST America, Inc. Full time

About MEDIPOST:

Not only is MEDIPOST the most trusted and largest umbilical cord blood bank in Korea, but we are also a commercial-stage cell therapy company developing novel umbilical cord-derived stem cell therapies to treat inflammation-driven degenerative diseases such as Alzheimer’s, Diabetic Neuropathy, and Osteoarthritis across the globe.


Our lead product, CARTISTEM, is the world’s first allogeneic stem cell therapy and treats patients suffering from moderate to severe knee Osteoarthritis (OA). Approved in Korea in 2012, we have treated over 28,000 patients to date. MEDIPOST has recently formed a joint venture with the Centre for the Commercialization of Regenerative Medicine (CCRM) to form Omniabio, a cell and gene therapy contract and development organization (CDMO) in Toronto. Leveraging our in-depth scientific and stem cell therapy development expertise, our 10 years of commercial and clinical experience with CARTISTEM, and our CDMO joint venture, Omnianbio, we now have a developing Phase III clinical program to expand CARTISTEM into the North American and European markets.


As MEDIPOST embarks on a journey to halt degenerative diseases such as osteoarthritis, we are seeking talented and experienced project management leadership who will manage globally the CMC, clinical, and regulatory tasks needed to achieve CARTISTEM BLA approval. In joining MEDIPOST, you will have a challenging and fulfilling role at the forefront of industry revolutionizing the healthcare sector.


As a pivotal member of our team, the Senior Program Manager (CMC) will report directly to the CEO, providing comprehensive support to internal project teams across cross-functional clinical trial, regulatory, and CMC endeavors. Collaborating closely with functional departmental leaders, this role will spearhead project management activities for CARTISTEM, spanning CMC, Clinical Development, and Regulatory functions, while also contributing to the enhancement of overall project management capabilities.


Serving as the primary liaison between MEDIPOST and our CDMO partners, the Senior Program Manager will orchestrate seamless collaboration between internal teams and external manufacturing partners, ensuring the successful execution of drug substance and drug product manufacturing. Moreover, this role will interface with clinical operations to oversee the clinical CRO engaged in supporting the CARTISTEM clinical trial. With accountability for all aspects of project design and execution, including CMC, clinical, and regulatory initiatives, the Senior Program Manager will provide strategic leadership to drive cross-functional project delivery aligned with our overarching disease and pipeline strategy. This entails directing project management operations across the developmental continuum, from preclinical research through registration, to realize our vision for transformative stem cell therapies.


Responsibilities:

• Develop and maintain comprehensive global project plans encompassing CMC, clinical, and regulatory workstreams, ensuring alignment with internal & external requirements and managing critical interdependencies to achieve corporate objectives effectively

• Direct and coordinate multiple projects to ensure delivery of project quality, budget, and deadlines

• Drive the development of an efficient process for scenario planning and option analysis for each project, optimizing resource allocation through effective resource planning and forecasting in collaboration with the finance team

• Identify, define, prioritize, and communicate risks for successful project execution; develop and manage risk mitigation and contingency plans, fostering a culture of analytical risk assessment and mitigation within the CARTISTEM program team

• Establish an operational framework for the CARTISTEM program team, including meeting structures, best practices such as agenda and minutes, and maintaining RAID logs, fostering efficient communication and decision-making

• Support the development and implementation of project management systems and best practices to ensure operational effectiveness within and across functions and departments

• Manage external suppliers, including contract manufacturing and development organizations (CDMOs), to ensure timely and high-quality delivery of CMC-related activities

• Facilitate integration among key cross-functional stakeholders to ensure alignment, operational efficiency, and program success, managing interdepartmental communication to ensure effective hand-off and coordination to achieve essential project milestones

• Collaborate closely with governance members and senior leaders to prepare, implement, and follow up on scientific and pipeline-related stage gates, decisions, and actions

• Mentor and develop junior project management staff to foster their professional growth and enhance the overall capabilities of the project management team.


Qualifications:

  • Bachelor’s degree required with a specialization in science, engineering, or related discipline; advanced degree (Ph.D, MS, MD) and/or PMP Certification is preferred. Advanced knowledge and experience in CMC Drug Development, namely for Cell & Gene Therapy, typically gained as a lead in CMC Development for Cell & Gene Therapy or Biologics modalities.
  • 10+ years post-graduate experience engaged in/leading projects in an industry environment. Previous experience working with or at CDMO; previous experience working with or at CRO a plus. Experience with late stage clinical programs and BLA submissions.
  • 7+ years project management experience and 5+ years leading cross-functional teams to execute on technical projects.
  • 6+ years of CMC experience supporting projection operations within biotechnology or pharmaceutical environment, experience operating, with at least 3 years of experience in cell or gene therapy manufacturing preferred.