Open to opportunities

Alysha McDonald

@alyshamcdonald

Message

Results-oriented Program Director with expertise in project management.

United States

Message

What I'm looking for

I am looking for a role that allows me to lead impactful projects, foster team collaboration, and drive innovation in clinical research.

I am a results-oriented Program Director with a proven track record of independently delivering projects on schedule and within budget. My experience spans various therapeutic areas, including Oncology and Neurology, where I have successfully managed complex clinical trials and led cross-functional teams to achieve top-tier deliverables.

At Celerion, I bridge the gap between strategic vision and operational execution, ensuring that programs are well-planned and effectively managed. I thrive in ambiguous settings, identifying potential risks and developing strategies to mitigate them. My leadership style fosters a collaborative atmosphere, mentoring project managers and ensuring that teams are high-performing and accountable.

With a strong educational background in biomedical sciences and certifications in regulatory sciences, I am committed to driving project success and fostering professional development within my teams. I am passionate about advancing clinical research and ensuring that projects meet sponsor objectives while maintaining compliance with regulatory standards.

Experience

Work history, roles, and key accomplishments

Current

Program Director, Global Project Management

Current

Celerion, Inc

Apr 2025 - Present (3 months)

Acts as the bridge between strategic vision and operational execution, ensuring that programs are well-planned, effectively managed, and ultimately deliver on sponsor objectives. Identifies potential risks and challenges that could impact program success and develop strategies to mitigate them.

Program Management Risk Mitigation Strategic Planning Team Leadership Budget Management Cross Functional Team Leadership Mentorship Stakeholder Management Clinical Trials

Global Project Manager II

Celerion, Inc

Apr 2024 - Present (1 year 3 months)

Independently managed Phase 1 clinical studies for a variety of therapeutic areas including Oncology, Neurology/Central Nervous System, and Hepatology. Served as the primary point of contact for projects, effectively bridging communication between internal functional groups and external stakeholders.

Vendor Management Mentorship Project Coordination Clinical Trials Communication Skills

Global Project Manager I

Celerion, Inc

Feb 2023 - Present (2 years 5 months)

Vendor Management Mentorship Project Coordination Clinical Trials Communication Skills

Clinical Trials Project Leader I

Duke Clinical Research Institute (DCRI)

Feb 2022 - Present (3 years 5 months)

Successfully managed timelines, resources, and budgets for government-sponsored Phase 1b-3b and 510(k) trials within a large infectious disease consortium. Led and mentored Associate Project Leaders in managing interventional and observational studies, fostering their professional development and ensuring project success.

Project Management Budget Management Resource Management Clinical Trials Infectious Diseases Mentorship Regulatory Compliance Clinical Research Team Leadership

Associate Project Leader

Duke Clinical Research Institute (DCRI)

Jan 2020 - Present (5 years 6 months)

Partnered with senior Project Leaders to manage complex clinical trials within a large infectious disease consortium. Developed and managed comprehensive project budgets based on approved scope of work.

Budget Management Process Improvement Clinical Trials Data Management Communication Collaboration

Project Assistant

Pharmaceutical Product Development (PPD), Inc

Jun 2019 - Present (6 years 1 month)

Maintained an audit-ready Trial Master File (TMF) through meticulous document review, query resolution, and system management. Reviewed study documents for completeness and adherence to regulatory standards before uploading to the TMF.

Trial Master File Document Review Regulatory Compliance Quality Assurance Clinical Operations Document Control Communication

Education

Degrees, certifications, and relevant coursework

University of Georgia

Master of Science, Comparative Biomedical Sciences

Completed a Master of Science in Comparative Biomedical Sciences. Thesis focused on how fibrinogen-depleted platelet lysate modulates monocyte and neutrophil function.