Director, Project Lead, Combination Products and Devices

Position Summary:

Upstream Bio is developing innovative therapeutics in inflammation. We are a nimble company with solid financial backing from high-quality investors. We have acquired a clinical stage asset with proof of concept in inflammation and plan to expand indications and seek to add at least one clinical program to build a pipeline in immunology/inflammation. Our offices are in Waltham, MA. We have a hybrid working model, with Tuesdays-Thursdays in the office and Mondays and Fridays flexible to work remotely if desired. Fully remote / non-local candidates may be considered on a case-by-case basis.

The Director. Project Lead, Combination Products and Devices will serve as the project’s leader for the combination products and device development and manufacturing efforts leading to regulatory submissions and subsequent clinical and commercial use. The ideal candidate will be a hands-on and multi-disciplinary project leader with a strong background in leading drug delivery device development projects. The candidate will provide overall project leadership in all phases of drug-device combination product development and manufacturing while working with internal and external stakeholders.

Key Responsibilities:

• Provide overall project leadership to cross - functional combination device teams including internal stakeholders and external partners through conceptualization, clinical development, product registration and commercialization.
• Lead the Combination Device Core Team and manage project management tools such as project schedule, risk registers, action items and dashboard updates to ensure smooth and efficient execution and communications, timely decisions, and effective risk mitigations.
• Direct planning and execution of the development and manufacture of combination products and devices by managing CDMOs.
• Assume overall ownership of project risks, timelines and budget as we as leverage relationships to lead strategy, planning and execution activities around combination device development and manufacturing projects.
• Leverage stakeholder relationships and knowledge of drug-delivery device development to influence stakeholders and ensure smooth and efficient execution of the project.
• Ensure that device development and manufacturing activities are aligned with the overall CMC plan and serve as the project representative to the CMC team.
• Lead stakeholders through risk identification and escalation and the ability for out-of-box thinking to solve issues that may impact project execution.
• Perform all other duties as assigned.

Qualifications:

• Degree in engineering, management or related field with a minimum of 15 years of experience in FDA Class II or Class III medical devices.
• A minimum of 7 years of experience in leading drug delivery and combination products development projects.
• Proficiency in working with drug development and manufacturing teams to ensure smooth interactions at the transition points.
• Proficient in managing external stakeholders and vendors.
• Extensive working knowledge and application of 21 CFR 820/Part 4, EU MDR, ISO 14971, ISO-13485 and other standards as well as drug cGMPs as they relate to the design and manufacture of medical devices and combination products.
• Must be able to communicate and collaborate effectively at all levels, both verbally and in writing.
• Proficiency in project management tools (MS Project, Smartsheet)
• Must be able to work with ambiguity and use good judgement in making decisions.
• Must be able to travel around 20% of the time.

The Following Additional Qualifications are a Plus:

• Experience in leading projects around combination projects (PFS, auto injector, on-body devices) through development and commercialization.
• Experience in working with drug development functions such as formulation, fill/finish and Analytical Science
• Knowledge of related functions such as Human Factors Engineering and drug fill/finish
• Knowledge of the latest development in the industry and provide key input into new device technology development.

Compensation

Target Salary Range: $196,537 - $240,212

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

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