Prieya Pavana Wason
Danville,CA
Summary
Dynamic Senior Director of Clinical Operations with a proven track record at Taiho Oncology, driving operational excellence and achieving 30% of R&D goals ahead of schedule. Skilled in alliance management and team leadership, I excel in cross-functional collaboration and strategic planning, ensuring successful execution of Phase I-IV studies and enhancing clinical operations efficiency.
Overview
26
26
years of professional experience
Work History
Senior Director, Clinical Operations
Taiho Oncology, Inc.
Pleasanton, CA
01.2024 - Current
- Lead clinical operations for Taiho’s key hematology trials, driving operational strategy and execution
- Successfully achieved 30% of company R&D goals by enrolling trials 1-2 months ahead of target for 2024
- Leader for the integration of two companies (Astex and Taiho), evaluating SOPs, processes, and operational tools, while promoting best practices and harmonization
- As a senior leader, responsible for resource planning, key hiring decisions, and fostering cross-functional collaboration and efficiency
- Active member of the Core Project Team, managing portfolio and lifecycle for key assets
- Conduct scenario planning to ensure study designs and clinical development plans are operationally feasible
- Lead CRO governance to ensure high-quality clinical studies within timelines and budgets, holding CROs accountable through detailed Key Performance Indicators
- Established and maintained strong relationships with Key Opinion Leaders, leading successful meetings at major US/EU Hematology conferences (ASH/EHA)
- Oversee the implementation of Risk-Based Monitoring and sponsor oversight through oversight plans
- Lead Diversity and Inclusion initiatives on Phase 3 trials in alignment with new FDA guidance
- Manage alliance and collaboration with key hematology program partners
- Partner with patient advocacy groups to raise clinical trial awareness
- Manage a team of 6+ employees and contractors within the department
- Continuously improve clinical operations deliverables and maximize the use of technologies like SAAMA and J-Review
Senior Director, Clinical Operations
ASTEX Pharmaceuticals
Pleasanton, CA
09.2020 - 12.2023
- Company Overview: (acquired by Taiho 12/2023)
- Oversee 3 molecules in the AML and MDS indications (Phase 1-3), including Astex’s two lead programs
- Provide operational strategy and direction to ensure clinical operational excellence
- Achieved 20-35% of company goals on time over 3 years
- A key strategic member of Project Core Teams for multiple molecules
- Lead alliance management with AbbVie for the 727/Venetoclax combination study
- Lead strategic meetings across departments to manage product lifecycle, study design, and develop Clinical Development Plans and Target Product Profiles for each compound
- Review and provide input on key trial documents, including Protocol, DSUR, PSUR, IB, CSR, and Briefing Book
- Oversee vendor operational activities, including study management, monitoring, specifications development, UATs, and issue escalation
- Implemented Risk-Based Monitoring for Phase 2 studies
- Actively engage with key stakeholders at major scientific conferences, including ASH (American Society for Hematology) and EHA (European Hematology Association)
- Developed and implemented departmental SOPs, WIs, and processes, including a Study Management Oversight Plan for department-wide use
- Managed and mentored 3+ direct reports, conducting performance appraisals and successfully completing promotion paperwork for 3 employees
- (acquired by Taiho 12/2023)
Director, Development Operations
NEKTAR THERAPEUTICS
San Francisco, CA
10.2018 - 08.2020
- Oversee multiple global studies from Phase 1 to 2 in NSCLC, Bladder, Melanoma, and other tumor types
- Represented Development Operations at Product Strategy leadership meetings regarding study design, operational strategy, and timelines
- Ensured the achievement of project and department objectives
- Developed Clinical SOPs and reviewer for cross-functional SOPs involving Development Operations
- Managed resource and workload utilization of direct report and contract staff
- Mentored and developed Development Operations staff, performance management, including hiring, training, coaching and performance reviews
- Developed clinical trial dashboards, monitor, and report on key performance indicators across programs to Sr
- Management
- Managed and coordinated with external laboratory service providers and vendors and others, serving as primary escalation point of contact, ensure thorough preparation of scope of work, ensuring agreed deliverables are achieved on time, and monitoring budget and key performance indicators
Sr. Clinical Operations Specialist II Lead (Director)
VERILY LIFE SCIENCES (Google)
South San Francisco, CA
03.2018 - 07.2018
- Contribute to strategic planning and development for clinical device studies and largest Baseline Health Registry
- Provided gap analysis on systems and processes needed for operational efficiency
- Improved sponsor communication with clinical sites and vendors
- Provide executive oversight and management for CRO and serve as escalation point for CRO issues
- Worked with Google engineers to contribute to software design involving site and patient user interface for eConsent and other tools for clinical trial management
Director, Clinical Operations and Associate Director, Clinical Operations
ADURO BIOTECH INC.
Berkeley, CA
03.2015 - 02.2018
- Oversaw planning and implementation of early-stage Phase 1-2 clinical trials for Pancreatic Cancer, Gastric Cancer, and Melanoma using modified Listeria vaccine technology
- In a small company environment, helped establish the Data Management and Medical Writing departments
- Collaborated with the Chief Scientific Officer and VP to develop resourcing plans based on company milestones and funding acquisition
- Contributed to strategic planning and development of GMO and antibody drug candidates
- Managed department resource planning, hiring, coaching, and overall management of Clinical Operations staff, including revamping job descriptions and career paths
- Provided executive oversight for clinical CROs, serving as the primary escalation point for CRO-related issues
- Led budget forecasting and functional budget reviews, ensuring adherence to clinical budgets
- Monitored CRO performance through key performance indicators (KPIs), attending CRO/study team meetings and regularly engaging with study teams
- Managed business partner alliances, including contract negotiations, pharmacovigilance and supply agreements, and providing program updates
- Worked closely with CPMs to ensure timelines, budgets, and plans aligned with operational goals and corporate objectives
- Developed and implemented internal SOPs and Clinical Work Instructions to ensure compliance with FDA and EMA regulations
Sr. Clinical Operations Consultant
INTERMUNE
Brisbane, CA
04.2013 - 03.2015
- Company Overview: (acquired by GENENTECH)
- Provided strategic operational leadership and direction for the Systemic Sclerosis- Interstitial Lung Disease program
- Lead cross functional project team meetings to ensure study execution and enrollment targets for key Phase 2 program
- Managed and mentored clinical team, regional CRAs, in addition to global CRO
- Responsible for identifying, securing and managing resource needs for clinical program
- Liaised with medical monitors on study design, protocol development and clinical program strategy
- Provided executive study updates to senior management and Steering Committee
- Lead for managing and executing Investigator and Study Coordinator Teleconferences and In person Meetings
- (acquired by GENENTECH)
Sr. Clinical Program Manager, Clinical Program Manager, and Senior CRA
ACTELION PHARMACEUTICALS, INC.
South San Francisco, CA
04.2007 - 04.2013
- Led the largest registry in the Pulmonary Arterial Hypertension (PAH) space, recognized by over 100 publications and medical school board exams
- Co-authored 7 abstracts and manuscripts related to the REVEAL registry
- Managed multiple studies, including Phase I, III, IV, and post-marketing trials across therapeutic areas such as PAH, connective tissue diseases (SLE, scleroderma), and orphan diseases (Gaucher’s disease)
- Organized and executed over 10 Investigator and Study Coordinator Meetings (200+ attendees) over 6 years
- Key strategist for 10+ steering committee meetings with leading KOLs in the PAH field
- Managed and resourced clinical operations team, including training, professional development, and performance reviews for 4+ FTEs
- Played an integral role in medical launch teams for new products in commercialization
- Developed and managed budgets for multiple clinical trials, including CRO negotiations for large-scale trials
- Delivered program updates to senior management and executive leadership, including scope changes, resource needs, and timeline adjustments, and presented program status at multiple Product Development Committee meetings
Clinical Research Associate II
PDL BIOPHARMA
Fremont, CA
09.2005 - 04.2007
- Lead CRA and study manager for Phase 2 and 3 studies in Multiple Sclerosis, Asthma, and Pediatric Hypertension
- Managed all CRO activities, central laboratories, IVRS and central reading centers
- Lead implementation teams for global studies and worked with international regulatory authorities
- Investigator and site selection for clinical trials, Pre-study visits, site initiations and routine monitoring visits
- Managed regional CRAs, reviewed visit reports, and addressed outstanding site issues
- Designed CRF completion guidelines and case study for trials of which the templates which resulted in a standard for other PDL studies
Clinical Research Associate II and Clinical Research Associate I
SCIOS INC. (acquired by JOHNSON & JOHNSON)
Fremont, CA
10.2002 - 08.2005
- Lead CRA for post marketing studies and largest registry in Congestive Heart Failure (ADHERE Registry)
- Responsible for investigator selection, site start-up, management, and close-out activities for 25 Clinical sites
- Planned and implemented multiple large scale in person Investigator and Study Coordinator meetings
- Implemented 3 different EDC systems along with CRF design (PhaseForward, Rave, MedNet)
Chemist I, II, III, Project leader - Research and Development
MICROGENICS CORPORATION
Fremont, CA
11.1998 - 10.2002
- Developed diagnostic assays for clinical laboratories in Therapeutic Drug Monitoring (immunosuppressants and antipsychotics) and Drugs of Abuse
- Led external evaluation sites and clinical trials for Class II devices
- Extensive experience in immunoassay research, including optimization, test method development, design control, antibody selection, and feasibility studies
- Contributed to the preparation of 510(k) submissions and Ministry of Health, Labor and Welfare filings for new products
Education
B.S. - Biological Sciences with emphasis in Molecular & Cellular Biology
University of California, Davis
Certificate - Clinical Trials Design and Management
UC Sant Cruz Extension
Skills
- Clinical Operations Strategy and Execution
- Organizational Leadership and Strategy
- Alliance and Partnership Management
- Clinical Finance Management
- Building and Leading Teams
- Clinical Operations Resource Management
- Phase I-IV and Post Marketing Studies/Registries
- Cross Functional Team Leadership
Publications
- Mannis G., Griffiths E., Savona M., Odenike O., Roboz G., Casey O’Connell C., Dillingham J, Wason P., Zhu L., Chan D., Keer H., Oganesian A., Dao K., DiNardo C., A Phase 1 Study Evaluating ASTX727 (decitabine and cedazuridine) and Venetoclax Combination Therapy in Newly Diagnosed AML Patients Unfit for Intensive Induction Chemotherapy., Volume 138, Supplement 1, 11/23/2021, 1245
- Ronan K., Thomas A., Catenacci D., Wainberg Z., Lin B., Enstrom A., Whiting C., Wason P., Murphy A., Brockstedt D., Moon A., Walling J., Lai R, Ku G., A Phase 2 trial of CRS-207 and pembrolizumab in adults with recurrence of metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinomas., Journal of Clinical Oncology, 02/26/2018, 36, 4 suppl
- Frost AE, Badesch DB, Barst RJ, Benza RL, Elliott CG, Farber HW, Krichman A, Liou TG, Raskob GE, Wason P, Feldkircher K, Turner M, McGoon MD., The Changing Picture of Patients with Pulmonary Arterial Hypertension in the United States: How REVEAL Differs from historic and non-US Contemporary Registries., Chest, 01/01/2011, 139, 1, 128-37
- Barst RJ, Ivy DD, Badesch DB, Benza RL, Elliott CG, Farber HW, Frost AE, Krichman A, Liou TG, Raskob GE, Wason P, Feldkircher K, Foreman A, McGoon MD., REVEAL Registry: Comparison of Patients With Childhood-Onset and Adult-Onset Pulmonary Vascular Disease Associated With Congenital Heart Disease., International Society for Heart and Lung Transplantation - 29th Annual Meeting., 01/01/2009, J Heart Lung Transplant., 28, 2 Suppl, S312
- Barst RJ, Ivy DD, Badesch DB, Benza RL, Elliott CG, Farber HW, Frost AE, Krichman A, Liou TG, Raskob GE, Wason P, Feldkircher K, Foreman A, McGoon MD., REVEAL Registry: Comparison of Patients With Childhood-Onset and Adult-Onset Idiopathic Pulmonary Arterial Hypertension., International Society for Heart and Lung Transplantation - 29th Annual Meeting., 01/01/2009, J Heart Lung Transplant., 28, 2 Suppl, S146
- Barst RJ, Ivy DD, Badesch DB, Benza RL, Elliott CG, Farber HW, Frost AE, Krichman A, Liou TG, Raskob GE, Wason P, Feldkircher K, Foreman A, McGoon MD., REVEAL Registry: Pediatric IPAH Versus Pediatric Pulmonary Vascular Disease Associated With Congenital Heart Disease., International Society for Heart and Lung Transplantation - 29th Annual Meeting., 01/01/2009, J Heart Lung Transplant., 28, 2 Suppl, S203
- Farber HW, McGoon MD, Benza RL, Wason P, Miller DP, Badesch DB., REVEAL Registry: Implications of Functional Class and Hemodynamics on Outcome in Patients with PAH., The Journal of Heart and Lung Transplantation., 01/01/2009, 28, 2 Suppl, S156
- Krichman A, Turner M, Wason P, Graves Jones A, McGoon MD, Farber HW., REVEAL Registry: Comparison of Functional Status in Adult PAH Patients With and Without Comorbid Medical Conditions., International Society for Heart and Lung Transplantation - 29th Annual Meeting., 01/01/2009, J Heart Lung Transplant., 28, 2 Suppl, S311-S312
- Shapiro S, Traiger G, Turner M, McGoon MD, Wason P, Barst RJ., Gender Differences in Pulmonary Arterial Hypertension: Are there differences regarding diagnosis, treatment, and outcome based on the REVEAL Registry., American Thoracic Society - 105th International Conference., 01/01/2009, Am J Respir Crit Care Med., 179, A2648
- Frantz, Barst, Turner, Wason P, McGoon., Regional Heterogeneity in Prostanoid Utilization for Pulmonary Arterial Hypertension in the United States., American Thoracic Society - 105th International Conference., 01/01/2009, Am J Respir Crit Care Med., 179, A3350
- Loor, Reuyming, C. Lingenfelter, P.P. Wason, K. Tang, D. Davoudzadeh., Multiplex Assay of Amphetamine, Methamphetamine, and Ecstasy Drug using CEDIA Technology., The Journal of Analytical Toxicology, 07/01/2002, 26, 5, 267-273
Awards
- Circle of Excellence, 2012, 1 of 25 in company to be honored for superior performance
- E-MAX Thank You Award, 2011, Executing flawless Investigator Meetings
- E-MAX Thank You Award, 2010, Meeting Enrollment timelines for Phase IV study
- E-MAX Thank You Award, 2009, Meeting FPV for study and executing Investigator Meetings
- Taiho Thanks, 2024, For efficient integration between Astex and Taiho
- Taiho Thanks, 2024, Achieving Corporate milestones for AML and MDS programs
Accomplishments
· Circle of Excellence 2012 – 1 of 25 in company to be honored for superior performance
· E-MAX Thank You Award 2011 – Executing flawless Investigator Meetings
· E-MAX Thank You Award 2010 – Meeting Enrollment timelines for Phase IV study
· E- MAX Thank You Award 2009 – Meeting FPV for study and executing Investigator Meetings
· Taiho Thanks 2024- For efficient integration between Astex and Taiho
· Taiho Thanks 2024 – Achieving Corporate milestones for AML and MDS programs
Timeline
Senior Director, Clinical Operations
Taiho Oncology, Inc.
01.2024 - Current
Senior Director, Clinical Operations
ASTEX Pharmaceuticals
09.2020 - 12.2023
Director, Development Operations
NEKTAR THERAPEUTICS
10.2018 - 08.2020
Sr. Clinical Operations Specialist II Lead (Director)
VERILY LIFE SCIENCES (Google)
03.2018 - 07.2018
Director, Clinical Operations and Associate Director, Clinical Operations
ADURO BIOTECH INC.
03.2015 - 02.2018
Sr. Clinical Operations Consultant
INTERMUNE
04.2013 - 03.2015
Sr. Clinical Program Manager, Clinical Program Manager, and Senior CRA
ACTELION PHARMACEUTICALS, INC.
04.2007 - 04.2013
Clinical Research Associate II
PDL BIOPHARMA
09.2005 - 04.2007
Clinical Research Associate II and Clinical Research Associate I
SCIOS INC. (acquired by JOHNSON & JOHNSON)
10.2002 - 08.2005
Chemist I, II, III, Project leader - Research and Development
MICROGENICS CORPORATION
11.1998 - 10.2002
B.S. - Biological Sciences with emphasis in Molecular & Cellular Biology
University of California, Davis
Certificate - Clinical Trials Design and Management
UC Sant Cruz Extension