Jack DONNELLY

- Responsible for strategic technical oversight, multi-site harmonization, and regulatory guidance across clinical research areas including skincare, haircare, supplements, sunscreen, safety, and claim substantiation.

- Serve as the technical point of contact for sales and business development, advising on clinical study design, marketing compliance, and regulatory feasibility.

- Lead discussions with stakeholders on pipeline development, trial strategy, regulatory pathways, and risk mitigation.

- Provide protocol development support and data interpretation for study reports, ensuring accuracy and compliance with FDA and ISO standards.

- Collaborate with Project Managers on IRB submissions, protocol adjustments, and subject-facing documentation.

- Author new SOPs and oversee implementation across study sites to ensure GCP, ICH E6(R2)/(R3), and site-specific readiness.

- Conduct regulatory intelligence research to keep the company aligned with evolving FDA, MoCRA, and ISO guidelines.

- Travel across North America (New Jersey, Ohio, Winnipeg, and Florida) to train site managers, implement procedural changes, and support site-level operational improvements.

- Participate in international site director meetings to align on budgets, staffing, workload distribution, audits, and best practices.

Key Achievements:

- Led operational integration of newly acquired Ohio facility (20+ staff) following corporate acquisition. Temporarily assumed the role of Site Director (Nov 2024 – Jan 2025) to assess and overhaul site processes, documentation, and infrastructure.

- Redesigned and delivered comprehensive GCP/ICH training across all site personnel, including modules on informed consent for adults, adolescents, and children, data collection, and system usage (Citrix Workspace).

- Recruited and onboarded new hires, building customized training plans to ensure early competency in compliance-critical procedures.

• Led the photobiology research department overseeing SPF, UVA-PF, and anti-pollution efficacy trials. Responsible for technical strategy, regulatory alignment, team supervision, and stakeholder collaboration across U.S. and UK operations.
• Supervised a team of 5 clinical technicians and 1 study supervisor, ensuring trial consistency, training, and high-quality performance.
• Provided ongoing technical guidance to project managers, including review of protocols, statistical outputs, and regulatory justifications.
• Participated in stakeholder meetings with business development and sales teams, delivering scientific insight into ingredient functionality, testing methodology, and claim substantiation.
• Conducted hands-on and virtual training (via Microsoft Teams and Zoom) for staff across departments, focusing on protocol development, legislative updates, clinical reporting standards, and marketing claim compliance.
• Maintained comprehensive logs and records, including staff training, temperature/humidity tracking, instrument maintenance, calibration certificates, test article usage, and budget documentation.
• Ensured GCP, ICH E6(R1)/(R3), and FDA compliance across all departmental processes and documentation.
• Conducted quality reviews of Trial Master Files (TMFs), providing structured feedback to ensure regulatory readiness.
• Ordered and tracked department resources including standard references, PMMA plates, UV bulbs, weights, and calibration materials.
• Utilized Microsoft PowerPoint to develop and deliver recurring training modules on sunscreen testing methods, protocol writing, raw data interpretation, and claim support.
• Maintained central records and documents using Dropbox, including protocol templates, calibration logs, TMF checklists, and IRB submissions.
• Ensured compliance with all relevant regulations, policies and procedures.
• Prepared presentations for board meetings summarizing key developments within the company.
• Served as a public spokesperson at industry events or conferences.

• 21 CFR 352 – Sunscreen Drug Products for Over-the-Counter Human Use & CARE Act (2020)
• Led OTC sunscreen clinical trials in accordance with 21 CFR 352, supporting SPF labelling and broad spectrum claims through FDA compliant efficacy testing, including water resistancy and UVA critical wavelength protocols.
• Coordinated with vendors to ensure the necessary resources are available for projects.
• Prepared study documents such as protocols, informed consent forms, case report forms.
• Communicated effectively with internal teams, external partners, investigators and other stakeholders throughout the lifecycle of a project.
• Conducted regular meetings with stakeholders to review project status and provide updates.
• Monitored progress of all clinical research activities, including data collection, analysis, and reporting.

• Experienced in clinical testing of OTC drugs under 21 CFR, with full adherence to FDA Monograph labelling, ingredients and performance standards.

o 21 CFR 350 – Antiperspirant Drug Products for Over-the-Counter Human Use.

o 21 CFR 333 Subpart D – Topical Acne Drug Products for Over-the-Counter Human Use.

o 21 CFR 358 Subpart H – Drug Products for the Control of Dandruff, Seborrheic Dermatitis and Psoriasis.

• Ensured GCP, GDP, ICH E6 (R1, R2, R3) compliance in all clinical trials.
• Lead pre-study meetings and provided protocol training to site staff.
• Increased site acne and dandruff subject database by 30% from local marketing, reaching out to local clinics.
• Cultivated vital client relationships, achieving an 80% client retention rate through exceptional project management and communication.
• Sponsors specially asked Business development for me to be assigned as the project manager for their trial.
• Received a 100% satisfaction rating from Sponsors in 2020.
• Protocol Development and clinical report writing.

• Provided guidance on GCP and ICH guidelines along with applicable regulations throughout the lifecycle of clinical trials.
• Developed and implemented project plans to ensure timely completion of clinical trials.
• Successfully managed over 30 clinical trials, including HRIPT, 96 Hour occluded patch, 21 Day Cumulative tests. Each trial consisted of 50-100 products from various Sponsors.
• End to end control of clinical trials.
• Complete standardized protocols, filling in client and test article information.
• Complete standardized reports, inserting eCRF’s, test article information, adverse events, writing conclusions.
• First point of contact with sponsor, and internal departments (Principal investigator, Business development, study coordinator, clinical technicians).
• Lead pre-study meetings.
• Create Source Documentation.
• Create eCRF’s.