Senior Project Manager

Medasource; Lake Forest (IL); On-site; USD 100,000 - 140,000; Full time

Job summary

Medasource in the United States is seeking a Senior Project Management Specialist to lead multiple CDx programs across clinical development and regulatory submission.

You will coordinate domestic and international teams, manage scope, timelines, budgets, and drive milestones with external pharmaceutical partners while ensuring FDA-regulated project standards.

Qualifications

• Bachelor's degree in a scientific/engineering/clinical/business field.
• Minimum 5 years in the medical device/biotech/diagnostics/pharma or FDA-regulated industry.
• Minimum 5 years of project management or related experience managing complex cross-functional projects.
• Experience with regulatory filings or submissions.
• Strong written and verbal English communication; ability to interact with senior leadership and external partners.

Responsibilities

• Lead 3–4 CDx projects across clinical development and regulatory submission.
• Serve as external-facing representative to pharmaceutical partners and global vendors.
• Define project scope with charters, integrated plans, milestones and success criteria.
• Establish project structure and cross-functional teams for new programs.
• Develop detailed schedules covering clinical, regulatory, R&D, quality, and design transfer.
• Lead cross-functional teams across Regulatory Affairs, Clinical, Quality, R&D, Design Transfer, PM.
• Manage risks, dependencies, budgets, and schedule changes throughout the lifecycle.
• Coordinate and facilitate meetings with agendas, minutes, decisions, and action items.
• Present status, risks, timelines, and metrics to leadership and external stakeholders.

Skills

Cross-functional leadership

Project management

English communication

Regulatory knowledge

Risk management

Education

Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, Clinical Research, or related field

PMP certification

GMP / Quality Systems training

FDA regulatory training (FDA device/IVD/Clinical/GCP)

Advanced degree (MS, MBA)

Tools

Smartsheet

Excel

Power BI

Job description

Job Title: Sr Project Management Specialist, CDx

Hours: 40 hours week, onsite 5 days

Start Date: ASAP

Client Overview: Our global diagnostics organization focused on developing molecular testing solutions that help detect, diagnose, and guide treatment for a variety of diseases. The team develops FDA-regulated diagnostic products and technologies across areas such as molecular diagnostics, PCR, and FISH. This particular group supports Companion Diagnostics (CDx), partnering with pharmaceutical companies to develop diagnostic tests that help identify patients who may benefit from specific therapies.

Job Description: The Senior Project Management Specialist will lead multiple projects across the full project lifecycle, working with domestic and international cross-functional teams supporting Companion Diagnostic (CDx) programs. The ideal candidate will take ownership of assigned programs, develop a strong understanding of the underlying clinical and regulatory requirements, and proactively drive teams toward key milestones and deliverables. This individual will collaborate closely with internal stakeholders across the broader Companion Diagnostics portfolio while serving as a key point of contact for external pharmaceutical partners. Strong communication, professionalism, attention to detail, and the ability to effectively lead and influence cross-functional teams will be critical for success.

Responsibilities:

• Manage approximately 3–4 Companion Diagnostic projects across various phases of clinical development and regulatory submission.
• Serve as a key point of contact and external-facing representative of pharmaceutical partners and global vendors.
• Clearly define and manage total project scope, including development of project charters, integrated project plans, milestones, deliverables, and success criteria.
• Lead significant upfront project planning, establishing project structure, identifying required stakeholders, and developing cross-functional teams for new programs.
• Develop and maintain detailed project schedules covering clinical, regulatory, R&D, quality, design transfer, and other program activities.
• Lead cross-functional project teams involving approximately 6–7 core stakeholders across Regulatory Affairs, Clinical, Quality, R&D, Design Transfer, and Project Management.
• Drive teams toward milestones and deliverables agreed upon with leadership and external partners.
• Manage project risks, dependencies, resource requirements, budgets, and schedule changes throughout the project lifecycle.
• Identify project issues early and work collaboratively with cross-functional teams to establish mitigation and resolution plans.
• Coordinate and facilitate internal and external meetings, including preparation of agendas, meeting minutes, decisions, action items, and follow-up activities.
• Ensure action items are appropriately assigned, tracked, and completed within established timelines.
• Recognize the broader clinical, regulatory, quality, and business implications of project decisions and incorporate those considerations into project planning.
• Support programs involving clinical studies and regulatory filings for FDA-regulated medical devices and diagnostics.
• Track project budgets and variances and recommend contingency options when necessary.
• Prepare and present project status, risks, timelines, metrics, and recommendations to senior leadership and external stakeholders.
• Utilize Smartsheet, Excel, Power BI, and other project management/reporting tools to maintain program visibility and communicate project performance.
• Partner effectively with international stakeholders and vendors, including teams in China, Japan, and other global markets.
• Create a collaborative working environment that drives accountability and cross-functional team effectiveness.

Requires Qualifications

• Bachelor's degree in a scientific, engineering, clinical, business, or related discipline.
• Minimum 5 years of experience within the medical device, biotechnology, diagnostics, pharmaceutical, or other FDA-regulated industry.
• Minimum 5 years of project management or closely related experience, with demonstrated success managing complex cross-functional projects.
• Experience within organizations engaged in the R&D, development, manufacture, or commercialization of FDA-regulated products.
• Working knowledge of medical device regulations, quality systems, GMP, and applicable industry standards.
• Experience supporting or managing clinical studies and/or clinical development activities.
• Experience working within regulatory-driven product development environments, including exposure to regulatory filings or submissions.
• Demonstrated ability to lead cross-functional teams and drive stakeholders toward established milestones and deliverables.
• Experience developing and maintaining detailed project plans, timelines, risks, resources, budgets, and project documentation.
• Strong written and verbal English communication skills with the ability to interact professionally with external pharmaceutical partners and senior leadership.
• Proven leadership skills with a results-oriented, highly collaborative, team-focused, and self-starting approach.
• Ability to operate effectively in a fast-paced environment while managing multiple concurrent projects.

Education/Certification(s)/License(s):

• Bachelor’s degree required in Life Sciences, Biology, Chemistry, Engineering, Clinical Research, or a related scientific/technical field.
• PMP certification preferred, but not required.
• GMP / Quality Systems training or certification is a plus.
• Training or certification related to FDA medical device regulations, IVDs, or clinical research/GCP is preferred.
• Advanced degree (MS, MBA, or similar) is a plus, but not required.