Nicole Marie Turcotte Mathes
Durham
Summary
Methodical and solutions-driven clinical operations leader with over 20 years of experience driving global clinical trial execution, operational excellence, commercial strategy, and cross-functional alignment across biopharma partnerships and biotech clients. Proven success in leading enterprise-level governance, optimizing portfolio performance, and championing innovation across all phases of clinical development (I–IV). Adept at navigating complex stakeholder environments, influencing senior leadership, and translating strategic vision into operational results. Recognized for building high-performing teams, fostering collaboration, and delivering measurable impact across neuroscience, rare disease, and metabolic therapeutic areas.
Overview
21
21
years of professional experience
6
6
Certifications
Work History
Senior Director, Strategic Alliance Lead
PPD, a part of Thermo Fisher Scientific
Durham
11.2025 - Current
- Collaborated with cross-functional teams to drive innovation in product development.
- Facilitated executive meetings to promote alignment on key initiatives and projects.
- Oversaw stakeholder communication, ensuring clarity of vision and project status updates.
- Developed and implemented strategic plans to maximize organizational efficiency, effectiveness, and profitability.
- Lead cross-functional teams in developing creative solutions to challenging problems.
- Promoted a culture of collaboration among staff members through regular communication, feedback, and recognition.
- Coordinated with stakeholders across multiple departments to develop innovative strategies for problem solving.
- Established key performance indicators to track progress towards goals.
- Built relationships with external partners, vendors, and customers in order to foster collaboration.
- Facilitated meetings between internal teams to ensure alignment on initiatives.
- Collaborated with executive leadership team to develop long-term objectives that would drive success.
- Assessed current organizational systems and infrastructure, recommending changes as needed.
- Created policies and procedures to improve operational efficiencies within the organization.
- Monitored industry trends and made recommendations on how they could be leveraged by the organization.
Senior Director, Development Operations
PPD
Durham
01.2024 - 10.2025
- As Development Operations Lead/Support, serve as operational escalation across assigned Sponsor partnership working in concert with commercial and operational colleagues to provide cohesive portfolio strategy and operational consistency.
- Responsibilities include: Serve as operational leader of the sponsor partnership business unit within PPD to support key operational relationships across all Phase I-IV therapeutic areas, functional departments, and any additional PPD business units.
- Represent Operations at governance meetings and work with Biopharma Account Lead to ensure appropriate escalation process and stakeholder management is supported at the correct levels within PPD.
- Oversees and facilitates governance within the partnership at the R&D enterprise level; champions innovation and cross-functional process improvement opportunities.
- Provide operational consistency of sponsor expectations across business segments and functional departments and proactively identify and implement innovation/solutions to address client growth drivers.
- Serve sponsor advocate within PPD and liaise with all business functions and study teams.
- Review KPIs, KQIs, KFIs and project performance, risk management and quality metrics at project, program, regional and partnership level to identify trends in risk or issues that present opportunities to leverage risk mitigation or PPD solutions across the portfolio/business unit.
- Review overall finances across portfolio/business unit to identify trends and liaise with therapeutic/business lead to mitigate risk and provide support in issue resolution and communicate mitigations/resolutions across partnership.
- Provide support and sponsor-specific training/onboarding of PPD resources to fully enable alignment with sponsor’s priorities.
Director of Development Operations
PPD
Durham
06.2022 - 12.2023
- As an Oversight Director, accountable for strategic indication or client-specific portfolio management within a Therapeutic Unit; expertly navigates the need to dive in/dive out of situations while ensuring the Project Lead remains empowered; provokes critical thinking in Project Lead related to execution of delivery, financial negotiations, prioritization; provides insight into proposal strategy in preparation for bid defense; works with Therapeutic Unit Head in development of business growth strategies; maintains awareness and engages as appropriate in the Contract Modification process; communicates with People Project Delivery.
Director of Project Delivery
PPD
Durham
04.2022 - 06.2022
Associate Director
PPD
Durham
04.2020 - 03.2022
Project Lead/ Senior Project Manager
PPD
Durham
11.2015 - 03.2020
Senior Director of Operations
NeuroCog Trials
Durham
09.2013 - 10.2015
- Active member of the senior management team, including SOP development, process improvement, meeting company objectives and emerging trends, new hire onboarding, and training; Advisor for technology development projects and innovative company strategies to improve efficiencies and reduce costs; Supervised and directed global project teams, preparing project associates and assistants for roles in project management; Provided extensive consultation between sponsors and in‐house teams cross‐functionally (DM, regulatory, clinical operations, etc.), scope of work decisions and building a comfort level with the internal teams; Selected to implement new business development and marketing strategy; increasing visibility into diverse therapeutic areas; Developed and implemented short and long-range operational objectives.
Operations Director
NeuroCog Trials
Durham
01.2006 - 09.2013
- Collaborator on development plans, including protocol designs, conference organization, competitive intelligence, strategies on global trials, KOL relationships, and advisory boards; Core member in the planning and execution of bid proposals and defense; securing company’s largest program to date; Financial and timeline responsibility for studies from scenario/option development to program execution: budgets, invoice approvals, forecasting, utilization, etc.; Managed/mentored project leads while maintaining operational responsibility for studies including site selection, investigator meetings, CRA training, resourcing strategies, risk management, data cleaning planning, preparation of study reference manuals, deliverables from multiple functional areas (DM, biostatistics, regulatory submissions, translations etc.); Prepared and executed all sponsor audits; exceeding regulatory and quality expectations; Established and maintained Standard Operating Procedures (SOPs) for company operations; Designed and organized internal IT structure, increasing efficiency throughout company protocols.
Project Lead, Neurocognitive Data Monitor/ Certification Specialist
NeuroCog Trials
Durham
01.2005 - 12.2006
- Operational lead on multiple high intensity Phase II and III global studies; Regions: US, Canada, Latin/South America (Mexico), Western Europe (UK, Spain, Germany, Poland, Italy) Eastern Europe (Ukraine, Russia, Croatia, Romania, Macedonia), the Middle East (Israel), Australia, and India (and start‐up activities in Japan, Indonesia, and China); Managed day-today operational aspects of domestic and global projects, effectively applying company methodology and the defined scope; Assessed rater qualifications for certification on neurocognitive batteries; Interviewed raters; discerning assessment administration and scoring competence.
Education
Master’s Degree - Organizational Leadership
Gonzaga University
Washington05.2013
Bachelor’s Degree - Psychology
Saint Anselm College
New Hampshire05.1998
Skills
- Enterprise Governance & Strategic
- Alignment
- Global Clinical Trial Operations (Phases I–IV)
- Biopharma Partnership Management
- Portfolio Oversight & Risk Mitigation
- Cross-Functional Leadership & Stakeholder Engagement
- Financial Strategy & Contract Negotiation
- Process Innovation & Change Management
- Regulatory Compliance & Quality Assurance
Affiliations
American Society of Gene & Cell Therapy (ASGCT)
Certification
Clinical Development Strategies: Beyond Clinical Trials – Harvard Medical School, 2024
Clinical Trial Experience
- Neuroscience/Rare Disease, Efficacy and safety of XXX combination therapy in patients with symptomatic generalized Myasthenia Gravis
- Neuroscience/Rare Disease, Phase 1 Study to Evaluate Dose Selection, Safety, and Activity of XXX in Adult and Pediatric Participants with Friedreich’s Ataxia
Personal Information
Title: Senior Director
Languages
English, Native
Publications
- Normative Study of the German language TOMMORROW Neuropsychological Battery, 2015, Clinical Trials in Alzheimer’s disease (CTAD) Annual Meeting, Barcelona, Spain
- Normative Study of the Italian language TOMMORROW Neurocognitive Battery, 2015, Clinical Trials in Alzheimer’s disease (CTAD) Annual Meeting, Barcelona, Spain
Professional Development
- PPD Gene Therapy Academy, 2020
- Biotech University, 2019
- General Six Sigma courses, 2016
- LEAD Performance, 2016
- EDGE Certification, 2016
Computer Experience
- ETMF (Veeva Vault platform)
- EDC (RAVE, Inform)
- CTMS (Oracle-based, Veeva)
- EPRO (Virgil, Pathway)
- Adobe InDesign
- MS Office (Word, Excel, PowerPoint, Project, OneNote, Teams)
- Mac OS (Merlin, Numbers)
- Generative AI
Timeline
Senior Director, Strategic Alliance Lead
PPD, a part of Thermo Fisher Scientific
11.2025 - Current
Senior Director, Development Operations
PPD
01.2024 - 10.2025
Director of Development Operations
PPD
06.2022 - 12.2023
Director of Project Delivery
PPD
04.2022 - 06.2022
Associate Director
PPD
04.2020 - 03.2022
Project Lead/ Senior Project Manager
PPD
11.2015 - 03.2020
Senior Director of Operations
NeuroCog Trials
09.2013 - 10.2015
Operations Director
NeuroCog Trials
01.2006 - 09.2013
Project Lead, Neurocognitive Data Monitor/ Certification Specialist
NeuroCog Trials
01.2005 - 12.2006
Master’s Degree - Organizational Leadership
Gonzaga University
Bachelor’s Degree - Psychology
Saint Anselm College