RICHARD J. SAWYER
Arlington,MA
Summary
Seasoned Clinical Operations Manager and talented leader with 28 years of experience applying exceptional planning and problem-solving abilities toward enhancing business plans and day-to-day activities. Results-driven and resilient in developing teams while improving processes and increasing productivity. Bringing solid understanding of industry trends, excellent communication skills, talent for spotting areas in need of improvement and implementing changes with strategic approach.
Overview
28
28
years of professional experience
Work History
Head, Clinical Operations Managers
Takeda Pharmaceuticals
06.2022 - Current
- Provide supervision for 6 Director COM Managers in managing 80+ COMs/Study Leads and 20 consultants, including hiring/staff selection and assignment of individual studies across all non-Oncology Clinical Development Programs
- Responsible for onboarding, overall training, completion of goals, development plans, performance reviews and Talent Management for all staff.
- Empowered employees to take ownership of their responsibilities, leading to increased accountability and improved performance outcome.
- Achieved higher employee retention rates by fostering a positive work environment and providing opportunities for professional growth.
- Directed initiatives to improve work environment and company culture which contributed to overall organizational success.
- Study Operationalization Advisory Co-Lead for the New Way of Working Initiative in focusing efforts on building out processes and capabilities for in-house sourcing model.
Senior Director, Clinical Operations Team Lead (Neuroscience)
Takeda Pharmaceuticals
04.2019 - 06.2022
- Accountable for clinical operations strategy, execution and management of clinical programs (representing Phase 1 – 3 studies) in Neuroscience Therapeutic Area Unit (TAU).
- Responsible for Global Clinical Operations financial planning/forecasting and budget management for Neuroscience TAU.
- Represented Global Clinical Operations as primary point of contact for TAU Head, internal stakeholders and Strategic Partners and vendors.
- Responsible for functional leadership for clinical operations, including hiring, training, staff assignments, coaching, mentoring, and performance management (including compliance) of various Directors, Associate Directors and Sr. Managers.
- Optimized project timelines by effectively delegating tasks and prioritizing workload among team members.
- Fostered work culture of collaboration and inclusion to increase morale and reduce turnover.
- Led the development of consistent Clinical Operations processes and creating the support for unified approaches across all TAUs.
Director, Clinical Operations Team Lead (Neuropsychiatry/Gastroenterology)
Takeda Pharmaceuticals (formerly Shire)
12.2015 - 04.2019
- Accountable for oversight, strategic and operational management (including financial management), execution, and delivery of clinical development programs (representing Phase 2 – 3 studies) in Neuropsychiatry and Gastroenterology Therapeutic Areas (TAs).
- Worked closely with organizational leadership to guide operational strategy.
- Responsible for integration of new acquisitions/assets into TA.
- Responsible for direct line management, professional development and mentorship of Associate Director, Clinical Program Leads as well as Sr. Clinical Project Managers (CPMs) and various CPM Contractors.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Established culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
- Represented programs on Clinical Research Organization (CRO) oversight management committees such as Joint Operations Committee (JOC) and Governance meetings.
- Responsible for strategic initiatives for process and business improvements.
Associate Director, Clinical Operations Sciences
Biogen
07.2014 - 12.2015
- Clinical Development Team (CDT) Lead for various early stage (Phase 0 – 2) Immunology (Sjogren’s, Systemic Lupus Erythematosus (SLE) and Scleroderma) Program.
- Responsible for merging in-depth clinical and scientific expertise with broad operational knowledge in leading teams in partnership with Lead Medical Director in building effective and innovative Clinical Development Plans (CDPs) while leveraging expertise from other various functions.
- Established program level operational strategy in support of CDP for studies within programs to ensure that all studies within programs are completed, on time, within budget and in compliance with Standard Operating Procedures (SOPs), regulatory regulations and ICH/GCP guidelines and in alignment with Therapeutic Area strategies and goals.
- Responsible for leading various CDT Working Groups in delivery of key components of the CDP as well as participation in various business development evaluations as operational expert.
Associate Director, Clinical Operations Management
Biogen
04.2013 - 07.2014
- Key architect in building the new Clinical Operations Management (COM) group by defining, developing and embedding operational expertise across the COM group to secure excellence in operational strategy and execution through the developing CRO partnership model
- Early Phase (Phase 0 – 2) direct line management, responsibilities for a group of 13 high functioning Clinical Operations Leads whose primary responsibilities were setting the strategic operational direction of various studies for their CRO counterpart.
- Developed close collaboration with key stakeholders across Global Clinical Operations, Development Sciences and other Biogen functions to secure alignment in operational direction and delivery while also ensuring consistent, efficient processes across the entire the COM group.
- Primary owner of the Clinical Program Strategy Process space (consisted of the CDP template as well as various SOPs and other supporting documents).
Clinical Program Leader
Biogen
02.2012 - 04.2013
- Managed all global operational aspects of two early stage Programs (Alzheimer’s Disease and SLE) while leading the CDT in development of the CDP in partnership with the Lead Medical Director.
- Leveraged TA strategy and scientific input when planning program feasibility, developing strategies for country selections, CRO/ 3rd Party Vendor evaluations and planning for contingencies.
- Direct line management responsibilities for two Clinical Trial Managers.
Associate Director, Clinical Research
Genzyme Corporation
03.2008 - 02.2012
- Global Clinical Leader for a rare genetic disease Program, Niemann-Pick Disease (NPD).
- Responsible for leading a global clinical team in strategic development, implementation, and completion of relevant clinical components of the global development plan in accordance with product profile, GCP and SOPs.
- Responsible for ensuring effective clinical team dynamics, developing strong strategic relationships outside the clinical team with all key stakeholders, working closely with all functional groups (e.g Regulatory, Data Management, BioStatistics, Safety, and Medical) in developing detailed program timelines and milestones, identifying clinical resources (internal and external) needed to achieve program objectives, and in working collaboratively with the Business Unit program manager to track and maintain accurate clinical forecast with meaningful accountability.
- Managed all clinical start-up activities including selection of sites and development/review of all study related documents (including but not limited to Protocols, Project Management Plan, Informed Consent Form, Study Operations Manual (SOM), Case Report Form and Study Site Contracts) for a Phase II NPD Study.
- Responsible for operational oversight and performance management for two internal Clinical Research Associates (CRAs) as well as eight contract employees (Senior CRAs, CRAs and Clinical Trial Assistants) for a key Small Molecule Gaucher Disease Program.
- Responsible for implementation of all clinical components of a Phase II Small Molecule Study.
- Key member of the project management process team.
Manager, Clinical Research
Genzyme Corporation
12.2004 - 03.2008
- Lead Clinical Project Manager (CPM) for NPD, instrumental in implementation of all clinical components of a pivotal Phase 1 Study as well as both Prospective and Retrospective Natural History Studies.
- Responsible for leading team meetings, managing vendors, reviewing CRA site monitoring reports, completion of study budgets and forecasting, development/review of all study related documents, oversight of all study related timelines, as well as line management responsibilities for one Clinical Research employee.
- Played key role in design of three Pompe Disease Studies, as well as Clinical representative on following committees: Harmonizing Global Clinical Standard Operating Procedures, Clinical/Data Management Sub-Team and Recruitment Team.
Principal Clinical Research Associate
Genzyme Corporation
07.2002 - 12.2004
- Responsible for managing and coordinating all clinical activities for two Phase 4 studies and Investigator Initiated Gaucher Disease Studies.
- Also participated in development/review of all study related documents as well as presented at Investigator Meetings, responsible for management of multiple vendors and in oversight and development of a Clinical Research Coordinator.
Senior Clinical Research Associate
Genzyme Corporation
07.2001 - 07.2002
- Managed, coordinated and monitored all clinical activities for two Phase 4 Gaucher Disease Studies.
- Participated in development/review of study related documents.
Senior Clinical Research Associate
Muro Pharmaceuticals, Inc.
04.2000 - 07.2001
- Managed, coordinated and monitored all clinical activities for a Phase 1 Oncology and Phase 2/3 Respiratory Studies.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Participated in development of study related documents.
- Communicated project status to management verbally and through technical documentation and presentations.
Clinical Research Associate
Quintiles, Inc.
06.1997 - 04.2000
- Lead CRA for a multi-center, Phase 3, Cardiovascular Study.
- Responsible for coordinating and monitoring clinical activities across offices and working closely with management to oversee study progress, timelines, and deliverables to management and customers.
- Participated in development of Protocols and Study Operations Manuals as well as in organization of investigator meetings and project specific CRA training.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Coordinated mentoring program for new clinical staff.
- As CRA on Phase 3 and 4 Cardiovascular Studies, responsibilities included: Investigator recruitment and evaluation, site selection, study initiation, periodic monitoring and study close-out visits in accordance with FDA regulations, GCP and ICH guidelines, internal SOPs, and project specific requirements.
Clinical Research Assistant
Quintiles, Inc.
03.1996 - 06.1997
- Assisted Clinical Research Associates with in-house monitoring; performed on-site monitoring under Associate supervision; maintained clinical study and regulatory files; edited clinical administrative database; maintained verbal and written correspondence with clinical personnel for multi-center studies for various Cardiology Phase 4 and Diabetes Phase 3 Studies.
- Performed on-site co-monitoring for multi-center studies for various Cardiology Phase 4, Diabetes Phase 3, and CNS Phase 3 Studies.
Education
Organizational Behavior Class -
Harvard University Extension School
Cambridge, MA01.2004
Bachelor of Science - Zoology
University of Rhode Island
Kingston, RI01.1995
Skills
- Team Management
- Clinical Trial Management
- GCP Knowledge
- Adverse event reporting
- Site monitoring
- Study design
- Patient recruitment
- Investigator relations
- Protocol development
- Clinical Leadership
- Document Management
- Effective Communication
Timeline
Head, Clinical Operations Managers
Takeda Pharmaceuticals
06.2022 - Current
Senior Director, Clinical Operations Team Lead (Neuroscience)
Takeda Pharmaceuticals
04.2019 - 06.2022
Director, Clinical Operations Team Lead (Neuropsychiatry/Gastroenterology)
Takeda Pharmaceuticals (formerly Shire)
12.2015 - 04.2019
Associate Director, Clinical Operations Sciences
Biogen
07.2014 - 12.2015
Associate Director, Clinical Operations Management
Biogen
04.2013 - 07.2014
Clinical Program Leader
Biogen
02.2012 - 04.2013
Associate Director, Clinical Research
Genzyme Corporation
03.2008 - 02.2012
Manager, Clinical Research
Genzyme Corporation
12.2004 - 03.2008
Principal Clinical Research Associate
Genzyme Corporation
07.2002 - 12.2004
Senior Clinical Research Associate
Genzyme Corporation
07.2001 - 07.2002
Senior Clinical Research Associate
Muro Pharmaceuticals, Inc.
04.2000 - 07.2001
Clinical Research Associate
Quintiles, Inc.
06.1997 - 04.2000
Clinical Research Assistant
Quintiles, Inc.
03.1996 - 06.1997
Organizational Behavior Class -
Harvard University Extension School
Bachelor of Science - Zoology
University of Rhode Island
Similar Profiles
Nico JohnsonNico Johnson
Technician II at Takeda PharmaceuticalsTechnician II at Takeda Pharmaceuticals
Darima KhalzanovaDarima Khalzanova
Project Manager at Takeda PharmaceuticalsProject Manager at Takeda Pharmaceuticals
Milissa ShirleyMilissa Shirley
Lead Phlebotomy Technician at Takeda PharmaceuticalsLead Phlebotomy Technician at Takeda Pharmaceuticals