Job Description

Position Summary:

The Director of Combination Device Development positionwill lead the strategic and technical direction for the development and commercialization of combination products. This individual will serve as the project’s technical lead across internal and external device development efforts leading to clinical and commercial regulatory submissions and subsequent commercial product release. The ideal candidate will be a multi-disciplinary technical leader with a strong background in engineering biologic drug delivery systems. The candidate will provide engineering leadership in all phases of drug-device combination product development while working with internal and external stakeholders.

The successful candidate will report to the VP, Head of Technical Operations, and will be responsible for the following:

Key Responsibilities:

• Provide technical leadership to cross functional internal and external development teams through clinical combination product development, product registration and commercialization.
• Manage project budget and model resource allocation for combination product development programs.
• Develop and implement comprehensive development strategies for combination products, including design control and project timelines.
• Lead and manage external partnerships responsible for combination product development by establishing strong collaborative relationships and demonstrating ability to influence internal teams and external design and development partners, suppliers, and contract manufacturing service providers.
• Use technical expertise and engineering rigor to lead all technical project execution activities and assume overall ownership of the design and development process including but not limited to product requirements, design and development documentation, combination product test methods, deviation investigation & root cause analysis, design verification and validation (V&V) strategy and execution.
• Support the optimization of design and development process while maintaining compliance to all relevant regulatory requirements and international standards.
• Provide oversight to all suppliers, vendors, and contract manufacturing organizations supporting the design and development process of the combination product.
• Provide strategic technical input into the regulatory, clinical, and commercial program decisions.
• Lead and maintain the combination product risk management process inclusive of leading risk assessments, and identification & implementation of risk control measures with the cross-functional team.
• Collaborate closelywith the drug product and formulation team throughout the design and development process to ensure development of safe and effective product.
• Work with project and program managersto formulate and maintain the project plan and schedule to meet all business and regulatory milestones.
• Stay current with industry trends,new technologies, and regulatory changesrelated to combination products.

Qualifications:

• Bachelor’s degree in engineering with a minimum of 15 years of experience in FDA Class II or Class III medical devices (or) a master’s in engineering with a minimum of 10 years of experience in FDA Class II or III medical devices.
• A minimum of 10 years of experience in developing drug delivery and combination products such as pre-filled syringes, auto-injectors or on-body devices for biologics
• Proficiency in working with drug development and manufacturing teams to ensure smooth interactions at the transition points.
• Proven leadership in managing complex cross-functional teams.
• Proficient in managing externalstakeholders and vendors.
• Extensive working knowledge and application of 21 CFR 820/Part 4, EU MDR, ISO 14971, ISO-13485, ISO 11040 and ISO-11608 series and other standards as well as drug cGMPs as they relate to the design and manufacture of medical devices and combination products.
• Strong technical expertise with device development methodologies, including Design Control, Risk Management, and Usability Testing
• Must be able to communicate and collaborate effectively at all levels,both verbally and in writing.
• Must be able to work with ambiguity and use good judgement in making decisions.
• Experience in statistical analysispackages (Stat Ease, Minitab) preferred.
• Experience with regulatory submissions and meeting support.
• Experience in Biologics and Biotechnology
• Knowledge of adjacent functionssuch as Human Factors Engineering
• Knowledge of the latest development in the industry and provide key input into new device technology development.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at upstreambio.com.

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