3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow the replacement of each individual patient’s parts with tissues designed and created specifically for them. 3DBio has developed unique capabilities toward the creation of living tissue implants for therapeutic applications. The technology platforms include a full suite of features to meet the FDA’s requirements for therapeutic manufacturing, including novel and proprietary: 3D-bioprinter (GMPrint™), bio-ink (ColVivo™), and cell processes. In preclinical studies, the platform has demonstrated the ability to generate functioning living tissues and 3DBio is currently in clinical Phase 1/2a.

The Vice President of Product Development will lead the product development function. The successful candidate will expand the function to support multiple product development teams each with a focus on a different therapeutic area. The VP will develop and lead robust development processes for stage gate product development of Biologics and Class II & III medical devices. Facilitate multi-discipline convergence and synergy within matrixed cross-functional teams to move products efficiently through the pipeline from early phases through product launch in US and Global markets. The role includes all aspects of development including resource planning, filling competency gaps, budgeting, and talent and leadership development. The VP will be involved in strategic pipeline planning, external KOL development, as well as BD assessments.

Responsibilities:

  • Ensure that portfolio products are managed and developed from feasibility to market launch.
  • Drive the strategy of all Product Development teams to align with the company’s broader vision for growth and market expansion.
  • Oversee management of project priorities, coordination of development activities, project deliverables, and resources across all product development teams.
  • Develop and expand our high-performing team by effectively hiring to fill talent/skill gaps and leading and coordinating activities for talent and leadership development.
  • Ensure that appropriate technologies, capabilities, and capacities are identified, evaluated, and implemented on a continuing basis to deliver on critical milestones.
  • Oversee collaborative efforts and knowledge/technology transfers with other functional areas of the company based on agreed-upon timelines
  • Liaise with leadership to translate pipeline strategy and project goals into project plans, tactical and functional executable roadmaps for the appropriate teams
  • Report directly to Chief Scientific Officer and serve as functional expert and strategist for R&D and product development space

REQUIRED EDUCATION, EXPERIENCE, AND SKILLS:

  • Accredited Ph.D. in relevant scientific discipline and 15+ years of experience in the development and manufacturing of biologic therapeutics and/or related medical devices in the regenerative space
  • Demonstrated experience successfully leading two or more functional business areas
  • Demonstrated experience successfully managing external vendors for outsourced development and manufacturing
  • Strong ability to drive decision-making using data and influence to achieve team alignment
  • Demonstrated experience establishing effective strategic plans to execute on needs of the company’s portfolio, including risk identification and mitigation, capability building, resource management, etc.
  • Demonstrated experience championing a people strategy that attracts, retains, and engages employees
  • Demonstrated experience with regulatory submissions, developing technical sections of submissions, and interacting with global regulatory authorities on science and technical matters
  • The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation

PREFERRED EDUCATION, EXPERIENCE, AND SKILLS:

  • Prior experience managing Biologics and/or Class III Medical Device product development, cartilage scaffolding, orthopedics, neurosurgery, or reconstructive surgery
  • Business experience involving intellectual property, technology transfer, budgeting, operations management, quality assurance & regulatory affairs
  • Experience with international collaboration