Todd D. Greer II

Experience

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  US Navy

  Oct 1986 - Oct 2002

  Naval Officer

  •Served 16 years in the U.S. Navy with various assignments: including 3 years on fast attack submarine, several major staff duty assignments at squadron, group level & in a training command. Assigned to several joint task forces, including: Operation Desert Storm/Desert Shield as a prisoner detention officer, Joint Task Force Guantanamo Bay as a personnel administrator (non-commissioned officer in charge (NOIC)), a military nurse in Kandahar, Afghanistan following September 11, 2001, w/ the 26th MEU from Camp LeJeune with the Fleet Hospital. •Selected number 1 of 50 candidates from 2,500 potential candidates for the Medical Enlisted Commissioning Program in 2001. •Successfully managed $100 million budget for major staff command of 10,000 sailors.•Completed U.S. Navy training as a TQM/TQL trainer & delivered training to peers on Deming’s management/leadership approach.•Received 16 Admiral Citations & 26 military decorations, ESS Warfare Device, MT Specialist, CCC badge & two Sailor of the Year selections.•Attained certifications as EMT/P (specialized in combat and field medicine) & instructor/trainer for BLS/ACLS/PACLS/NALS/BTLS & First Aid.•As Navy Nurse, utilized problem solving & decision making skills to care for patients w/ various injuries & diseases in a 12-bed Emergency Room (ER). (On average, the ER cared for over 60,000 patients a year at Camp LeJeune Naval Hospital.) Acquired, evaluated, interpreted & communicated information effectively to patients & families. Performed during high stress situations ensuring quality patient care while adhering to operational standards.•Provided patient care in multiple combat situations overseas. •Assisted in JHACO inspections & in training new personnel on proper safety procedures. Supervised staff performance of over 70 personnel to ensure floor safety/treatment compliance in all operational areas. Show less

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  PPD

  Sept 2002 - Oct 2006

  Lead CRA/Quality Systems Auditor III

  •Performed & coordinated all aspects of the clinical monitoring & site management process at 25 global sites with over 100 protocols in accordance w/ ICH/GCP/FDA local & PPD guidelines. •Performed QM & Compliance audits, assessing CRA compliance w/ GCP & all Federal regulations, PPD directives & applicable protocols. Documented audit observations for use by senior management. Evaluated & implemented services based on site-specific internal quality management plans & provided training to enhance implementation efforts of various consumers. •Mentored new QMCS auditors & trained division staff, sponsor & clinical site staff on QM.•Assisted in the preparation of the monitoring guidelines to be used by all monitors on the study & what to review, complete & submit for each monitoring visit.•Personally selected to be a part of the initial PPD mentoring program. Assisted in thecreation & implementation of the entire program.•Assisted in the review of all trip reports, expense reports & protocols.•Considered pharmaceutical expert in storage, handling & dispensation ofinvestigative drugs in studies.•Key trainer for all new staff in policies, procedures & the monitoring process.•Successfully managed several crisis issues related to the report & handling of SAEs. •Provided consulting to internal PPD staff & to the National Institute of Health on GCP compliance. Prepared & presented information at NIH & client sponsored meeting, internal meetings & in-service programs to study team personnel on GCP issues w/ minimal guidance. •Role model & mentor to junior monitors in their monitoring & interaction roles w/ sites. •Assisted in the management of each study budget ensuring that the study team stayedw/in budget.•Reduced overspent man-hours by 15% by verifying time sheets & ensured proper billing to each sponsor. Show less

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  Roche

  Oct 2006 - Feb 2007

  Contractor - Field Clinical Trial Manager

  • Managed sixteen investigative sites participating in two Phase III Rheumatoid Arthritis clinical studies/trials across the United States. Performed and coordinated all aspects of the clinical monitoring and site management process, ensuring compliance with ICH, GCP and FDA guidelines, local regulations and company SOPs. • Conducted initiation, interim, and close-out visits according to applicable SOPs and FDA guidelines. Assessed protocol and regulatory compliance and managed required documentation. Reviewed all electronic case report forms for completeness, clarity, legibility and conformity to available source documentation. Performed accountability for all investigational drugs (dispensation, storage and proper preparation) and ensured all adverse and serious adverse events were reported accurately, in sufficient detail, and without delay. • Represented company in the global medical research community and developed and maintained collaborative relationships with investigational sites and client company personnel.• Collected and reviewed all essential regulatory documents per required guidelines and utilized the GIZMO monitoring/reporting system for documentation of all site visits and generation of reports for management and the sponsor.• Key Accomplishments:• Contributed to success of project team in receiving FDA approval for tocilizumab(Actemra) in January 2007. • Successfully resolved several crisis issues involving reporting and handling of SAEs, as the liaison for each site overseeing SAE submissions and ensuring the informationwas complete and properly detailed. Show less

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  PPD

  Feb 2007 - Feb 2008

  CRA Specialist

  •Managed 17 nationwide sites in 3 protocols for HIV subjects. Performed & coordinated all facets of the clinical monitoring & site management process as a team lead of PPD’s AVAI Division. Conducted monitoring visits to identify, assess & address/rectify problems & ensure compliance w/ ICH/GCP/FDA/local & company guidelines. •Collected & reviewed essential regulatory documents. Both paper and electronic CRFs to source documentation for adherence to protocol requirements. Conducted monitoring tasks in accordance w/ the approved monitoring plan. Responded to company, client & federal regulatory requirements/audits. Performed IP accountability procedures & ensured prompt reporting of AEs. •Assisted in the preparation of the monitoring guidelines to be used by all monitors on the study & what to review, complete & submit for each monitoring visit.•Represented PPD in the global medical research community & developed & maintained collaborative relationships w/ sites & clients. Identified potential investigators w/ the client. •Lead project team building by mentoring new members, assisting in preparation of project communications & tools & sharing ideas & suggestions w/ team.•Facilitated effective communication between sites, the client and federal government & PPD project team through written, oral & electronic contacts. Documented site visits & issues in management reports & F/U letters to the site. Utilized the CASCADE monitoring reporting system for documentation of all visit information & visit reports. •Served on project team that received FDA approval for TMC114, darunavir (DRV) in 12/2007. •Deemed the CASCADE reporting system expert; provided training to new CRAs & new site staff.•Considered the pharmaceutical expert in storage, handling & dispensation of IP in studies.•Successfully troubleshot crisis issues related to timely reporting & handling of SAEs. Show less

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  Kendle International

  Jan 2008 - Apr 2009

  Clinical Trial Manager

  Managed clinical teams in all aspects of clinical trials for new potential drugs in Phase II-IV clinical trials. Reviewed expense reports, metrics, trip reports for clinical research associates. Daily interaction with peers, employees and clinical research sites all over the United States.

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  PRA International

  Nov 2011 - Feb 2013

  Senior Clinical Trial Manager/Global Trial Manager

  Managed clinical teams in all aspects of clinical trials for new potential drugs in Phase II-IV clinical trials. Reviewed expense reports, metrics, trip reports for clinical research associates. Daily interaction with peers, employees and clinical research sites all over the United States.

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  PPD

  Sept 2014 - Jul 2016

  Manager Strategic Feasibility

  Oversee setup and conduct for allocated feasibility studies according to timeline and quality standards and client expectations.Lead internal planning meetings and contribute to client KOM and interim teleconferences.Oversee, in conjunction with Feasiblity Strategist, the development of initial site list development.Undertakes all required activities to ensure accuracy and quality of survey driven data, including review and QC of departmental deliverables at all stages of the feasibility conduct.Oversee and analyze project status to ensure successful completion of milestones, timelines and deliverables.Liaise with the global, cross-functional team, inclusive of legal, biostatistics, CM and PM.Work with team to identify potential risks and out of scope activity; discusses contingency plans with strategist and/or PM.Manage project budget hour for FS team.Ensure team in entering and updating internal tracking tools.Develop best practice for feasibility conduct.Develop and deliver training of feasibility requirements/processes.Allocate staff to projects and manage workload assignments and priorities.Conduct regular performance appraisals and career discussions with staff.Effectively recruit, induct and retain staff.Contribute to the development, testing and maintenance of eFeasibility system. Show less

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  GLG (Gerson Lehrman Group)

  Aug 2016 - Feb 2018

  Council Member

  Consulting on life sciences for cardiovascular, neurological, general medicine, infectious diseases and overall trial setup and cost.

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  DOCS

  Mar 2018 - Feb 2019

  Regional Clinical Trial Manager

  Responsibilities include: Leading the regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan, identifying and resolving issues at a regional level, collaborating with Global CTM to ensure country level study delivery is aligned with the global study project plan, contributing to study-level risk assessments, leading and continually reviewing regional risk mitigation activities to ensure study delivery to plan, overseeing regional insourcing/ outsourcing partner deliverables to the required standards, partnering with Tech Services, Supplier Governance and Electronic Trial Operations to ensure regional, country, and site vendor set-up conduct and quality, leading regional documentation and required tool and systems set-up, contributing to regional aspects of Drug Supply Plan, and ensuring implementation of study(ies) in accordance with SOPs and ICH/ GCP guidelines. Show less

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  Amgen

  Feb 2019 - now

  • Support recruitment of GCTM (FTE) staff• Hub-level functional oversight of the following GCPM roles:GCTM, RCTM, CTS & SMA Staff (FTE and FSP) in collaboration w/ the CPMs• Ensure GCPM staff adherence to operating standards & promote standardization & best practice sharing to ensure operational compliance• Managing Hub level performance issues & providing oversight to issues escalated to the FMT• Provide resourcing allocation oversight of GCTM, RCTM & CTS staff (FTE & FSP)• Provide input into GCPM training & develop standards authorship & review• Lead GCPM on strategic staff-focused process improvement initiativesLead the GCPM FSP FMT & provide input into the GCPM FSP OMT forums• Contribute to ongoing risk assessment & risk mitigation program at a GCPM Hub level• Support Head of Program Resource Management in planning & executing Hub Op Reviews• Responsible for ensuring resolution of performance issues for a given GCPM Hub & monitoring of GCPM Hub KPIs• Partner w/ external suppliers to ensure appropriate oversight of non-permanent staff• Partner & communicate effectively w/ key stakeholders regarding GCPM Hub performance• Oversee GCPM resourcing in close collaboration with key stakeholders• Support GCPM functional goal setting process• Lead/contribute to GCPM forum to drive operational efficiency w/I GCPM function.• Lead functional training to ensure consistent interpretation and application of Amgen process & standards, as well as facilitate best practice sharing w/I GCPM• Support roll-out of new business process & initiatives to ensure consistent application by GCPM staff• Contribute to development & maintenance of policies, SOPs & associated documents• Represent the GCPM function by contributing &/or leading initiatives for the continuous improvement of clinical trial planning & execution• Support the onboarding activity alignment & plans for FTE & FSP staff W/I GCPM• Development & communication of department metrics Show less Develop regional (US) clinical investigator and operational profiling in line with global development portfolio to inform Phase I-IV study designs and targeted country feasibility assessments in support of clinical trial delivery. Manage global, deadline-driven projects with cross-functional teams including vendors and contract research organizations (CROs/FSPs). Develop country operational plans to drive accurate and consistent enrollment and site start-up forecasting. Identify, evaluate and select qualified principal investigators and clinical sites for Amgen’s clinical trials across multiple therapeutic areas (focus on hematology, oncology, immunology). Engage with key opinion leaders, clinical sites, potential investigators, internal and external experts and other stakeholders. Currently oversee Cardiology, Gen Med, Neurology, Bone, Nephrology and Inflammation. Moving to work in Hem/Onc and ED. Show less

  • Senior Manager, Global Clinical Program Resource Management

    Aug 2021 - now

  • Development Feasibility Manager

    Feb 2019 - Aug 2021