Pablo Caiceo
Weston,FL
Summary
Accomplished bilingual Pharmacist with over a decade of experience, renowned for my proactive approach, unwavering commitment to quality, and proven track record of delivering results. My journey has been marked by successful leadership within multicultural and global teams, driving projects to success in the clinical trials and pharmaceutical industry.
My technical proficiency extends to pivotal aspects that steer global businesses toward triumph in clinical trials and pharmaceutical enterprises. With a comprehensive skill set encompassing new business development, regulatory compliance, operational excellence, leadership and coaching, as well as quality assurance, I possess a wealth of experience in the end-to-end project management of global clinical supply management for investigational medicinal products (IMP), clinical supplies, medical devices, and GMP/GCP/GxP regulated environments (CMO, P&L).
As a trailblazing change management expert, I have played pivotal roles in organizations undergoing rapid transformation, championing efficiencies and LEAN practices within teams. My focal point remains on elevating client satisfaction and upholding rigorous quality benchmarks. With a comprehensive financial acumen, I have effectively managed company and client budgets, seamlessly aligning forecasts with overarching corporate objectives.
I bring exceptional interpersonal finesse to the table, underscored by my talent for fostering cohesive teams and cultivating the professional growth of individuals. My leadership philosophy is rooted in nurturing high-performance cultures that seamlessly align with company values and long-term vision
Overview
7
7
years of professional experience
Work History
Director, Project Management Global Clinical Supplies
Thermo Fisher Scientific-PPD CRG
04.2023 - Current
- Assemble a synergistic task force with the purpose of precisely delineating the ramifications of incorporating lean organizational structure principles into the scope of global clinical supply services
- Explore potential Process Performance Improvement (PPI) models that could offer valuable contributions to the team's effectiveness
- Amplify the occurrences of collaborative engagements with internal as well as external stakeholders, fostering a more interconnected clinical supplies landscape
- Steer and empower team members through periods of change, fostering their active involvement and dedicated commitment to achieving business deliverables.
Associate Director, Project Management Global Clinical Supplies
Thermo Fisher Scientific-PPD CRG
04.2022 - 04.2023
- People Management: Global 2nd-line people leader with 4 direct reports (managers) and 54 indirect reports (project managers) in a global project management organization supporting clinical supplies
- Organizational Development: built clinical supply project management teams to align with business and sponsor needs, providing direct oversight of team members including development, training, coaching, and feedback
- Team Operations: met regularly with direct reports and indirect reports to provide mentorship/support, understand business landscape, resolve issues, and endorse next steps
- Performance Management: led team of managers and measured performance through goal setting aligned to company expectations and through development plans to support individual career growth
- Resource Management: support hiring by screening applicants, interviewing, and setting expectations
- Administration: review and approve timecards (detailed project-specific line items), expense reports, purchase orders, personal time off requests, requests for leave, etc
- Strategy: Strategy leader that develops and executes strategies and provides operational oversight to ensure team delivers projects compliantly, within scope, and are aligned to business requirements
- Strategic Initiatives: collaborated with cross-functional stakeholders to develop, plan, and drive a strategy that included strategic initiatives, projects, and workstreams that increased operational effectiveness, improved processes, and supported organizational change
- Change Management: led the updating of processes, standards, and governance (ensuring compliance within policies and procedures relevant to company SOPs, regulatory guidelines, and departmental written procedures) during company integration
- Forecasting: collaborated with data support teams on monthly basis to collect necessary data that provided resource forecasting and identified headcount needs.
Associate Director, Global Clinical Supplies
PPD
07.2021 - 03.2022
- Leader of the PPD GCS PMO management team team in Americas, EMEA and APAC region; specifically committed to develop and execute the PPD GCS PMO strategy and operations, including supervision of the team to ensure that PPD GCS PMO delivers projects in accordance with GxP and customs regulation to its clients and achieves agreed revenue margins covering all products offered by PPD GCS PMO
- Collaborates with senior management and executive staff on strategic planning and business development activities
- Develops and/or implements process improvements and makes recommendations in workload organization, managing and developing staff and their performance, continuously striving for operational excellence of the department by focusing on end results using metrics and key performance indicators to manage performance
- Responsible to ensure that appropriate management practices are in place (e.g., retention and development plans) to retain staff and maintain project and business continuity
- Ensure compliance with employment legislation, company policies and procedures relating to employees, relevant company SOPs, regulatory guidelines, and departmental written procedures, operate within the departmental budget and in accordance with departmental goals and objectives
- Responsible for client oversight of COVID-19 study managed in NA and APAC region.
Client Oversight Manager
PPD
07.2020 - 06.2021
- Manage full supply chain and interactive response technology oversight for global clinical trials
- Ensure project/study activities are in compliance with company and sponsor requirements
- Meet with internal teams to coordinate efforts, provide recommendations and risks, and update project reports/spreadsheets
- Serve as a GCS/IRT escalation contact with clinical project management teams and sponsors
- Develop GCS/IRT bidding strategy for each assigned bid
- Present and explain GCS/IRT capabilities to sponsors and aid in business acquisition
- Represent the GCS/IRT department for internal, sponsor and regulatory audits as needed
- Provide consultation services to sponsors and develop and update sponsor-specific manuals/standards
- Build and maintain sponsor relationships.
Senior Project Manager
PPD
03.2019 - 06.2020
- Responsible for providing overall global coordination of the entire clinical supplies lifecycle for the projects assigned
- Responsible for managing the full spectrum, least complicated to highly complex, without guidance
- These studies require primary and/or secondary packaging and labelling design, drug projections, drug distribution and returns, drug inventory management, budgeting and developing project specific material for multiple projects at the same time
- Provides consultation services to clients regarding global packaging, labelling, and distribution requirements
- Serves as the main point of contact between the client, clinical project teams, third party vendors, and study sites for entire programs that may include up to 5-10 individual studies
- Act as mentor to junior level Global Supply Project Managers.
Senior Manager. Country Head
Parexel International
02.2017 - 01.2019
- During this period in addition the ongoing Senior Manager role and responsibilities, I took the challenge to contribute as Technical Director and Legal representative for local Ministry of Health Chilean Authorities
- As Pharmacist (Pharm
- D) professional managing all aspects of administrative, technical and local communications with vendors, clients and health authorities
- In addition, representative of PAREXEL Asociación Gremial de Contract Research Organization de Chile (ACROCHI)
- Contributed in the elaboration of one of the training modules 'Nuevas Drogas de Investigación' in the first GCP course organized by ACROCHI Chile for clinical trial professionals in Chile
- Contributed in the negotiations with local facility vendor, Ministry of Health and legal entities in a business risk situation, which allowed a continuity of services and no impact to patient delivery
- Responsible for global initiative to manage project team and vendors responsible for translation of standard operating procedures (SOPs) to GER, SPA and POR with the objective to comply with global regulatory requirements and harmonize training scheme of operational staff.
Education
Ph.D. - Pharmacist
Universidad De Chile
Santiago de Chile, Chile01.2005
High School Diploma -
Instituto Alonso de Ercilla
Santiago de Chile, Chile01.1998
Skills
Strategic Planning
Verbal and written communication
People Management
Operations Management
Change Management
Financial Acumen
Supply Chain Management with GMP environment
Process Improvement
Affiliations
- Florida Soccer Referees
- Global Clinical Supplies Group
Professional Development
- Good Clinical Practice, 11/2018, ACROCHI Chile
- Business Acumen for Project Management, 05/2017, Insight Experience, PAREXEL International, Argentina
- Business Acumen and Client Communications, 01/2017, PAREXEL International, Argentina
- Managing Across Cultures, 05/2016, PAREXEL International, Massachusetts, USA
Therapeutic Experience
- Vaccines: COVID, Influenza
- Other Areas of Expertise: E.g., immunotherapy, CAR-T, rare disease, healthy volunteers, pediatrics
Audit experience
- Vendor or Sub contractor Audit
- Process Audit
- Computer Systems Validation Audit
- Clinical Supplies Facilities Audit
- Central Laboratory Facilities Audit
- Study File Audit
- Study Document Reviews/Audit
Computer Experience
- MS Word
- Word Perfect
- MS Excel
- MS Access
- Trackwise
- Veeva Vault
Hobbies-Soccer Referee
I have experience as a soccer referee in Florida, specializing in youth leagues. Over the past year, I have officiated numerous matches for various age groups, from U10 to U18. My role has involved enforcing the rules of the game, ensuring player safety, and maintaining a fair and enjoyable environment for all participants. I take pride in my ability to make quick, accurate decisions and communicate effectively with players, coaches, and parents. My commitment to fostering a positive sporting experience has earned me recognition and respect within the local soccer community.
Languages
Spanish
Native or Bilingual
English
Native or Bilingual
Timeline
Director, Project Management Global Clinical Supplies
Thermo Fisher Scientific-PPD CRG
04.2023 - Current
Associate Director, Project Management Global Clinical Supplies
Thermo Fisher Scientific-PPD CRG
04.2022 - 04.2023
Associate Director, Global Clinical Supplies
PPD
07.2021 - 03.2022
Client Oversight Manager
PPD
07.2020 - 06.2021
Senior Project Manager
PPD
03.2019 - 06.2020
Senior Manager. Country Head
Parexel International
02.2017 - 01.2019
Ph.D. - Pharmacist
Universidad De Chile
High School Diploma -
Instituto Alonso de Ercilla
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