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Director of Strategic Development

3 months ago

Ormond Beach, United States Germfree Full time
Job DescriptionJob DescriptionSalary:

Overview:

Germfree Laboratories is currently seeking a Director of Strategic Development to take a pivotal part in crafting innovative strategies for decentralized manufacturing of advanced therapies within our organization. We are in search of a visionary leader who can adeptly merge Germfree's product and services portfolio, digital strategies, core partnerships, and technology to elevate global access to vital therapies for patients worldwide.

 

Key Responsibilities

  • Collaborate closely with the Chief Strategy Officer to define and implement a robust digital framework that supports a decentralized, hub and spoke manufacturing model.
  • Lead the strategic evaluation and development of the business model for commercializing cell and gene therapies post-regulatory approval, leveraging expertise in technology-driven market transformations and high-growth environments.
  • Design and oversee the implementation of scalable manufacturing processes tailored for decentralized settings, particularly in cell therapies and viral vectors.
  • Establish and maintain GMP-compliant facilities internationally, enhancing supply chain resilience and production efficiency.
  • Forge and nurture strategic partnerships with a diverse array of stakeholders including apheresis centers, CROs, CDMOs, academic institutions, equipment providers, and regulatory bodies, with a strong acumen in building collaborations.
  • Coordinate with international regulatory agencies to ensure compliance and facilitate the global scalability of the manufacturing model.
  • Drive business development activities by leveraging existing customer engagements and identifying new opportunities within the decentralized manufacturing space.
  • Spearhead innovation in core technologies identified as critical to the decentralized manufacturing model, ensuring Germfree stays at the forefront of technological advancements.

 

Qualifications:

  • A minimum of 15 years of experience in strategic roles within the pharmaceutical or biotechnology industry, with significant expertise in cell and gene therapy operations and process development.
  • Demonstrated leadership in managing technology-driven transformations and strategic planning in high-growth environments.
  • Profound knowledge and practical experience with digital systems such as Electronic Data Capture (EDC), Electronic Medical Records (EMR), Manufacturing Execution Systems (MES), and/or Quality Management Systems (QMS).
  • Proven track record of developing technologies and services solutions that enhance production efficiency.
  • Experience in navigating regulatory and market access challenges, proficient in organizational change management.
  • Understanding of regulatory environments and experience engaging with international health authorities.
  • Exceptional leadership skills with a track record of building and maintaining high-performing teams and partnerships.
  • Exposure to the complexities of delivering cell therapy products through the healthcare system. Payer expertise a plus.
  • Experience working in service environments like CDMOs, CROs a plus.
  • Advanced degree preferred in Business, Biology, or a related field, with substantial knowledge of cell and gene therapy markets.

 

Skills:

  • Strategic thinking with a clear ability to design and implement complex business models.
  • Strong analytical and problem-solving skills, capable of navigating high-stakes decisions.
  • Excellent communication and interpersonal skills, adept at engaging with diverse international stakeholders.
  • High level of integrity and dependability with a strong sense of urgency and results-orientation.
  • Start-up company experience is highly regarded.