Management Manager

DEBORAH M. MANZO, MScOL

** ******* ******, **** *

Hampstead, NH 03841

Cell: 978-***-****

********@*****.***

EXPERTISE: Biopharmaceutical industry, organizational and change leadership, R&D

program and project management, clinical trial operations, quality and compliance

excellence, global clinical trial execution, relationship and stakeholder management,

training and development, solution oriented strategic management, operational

excellence and process improvement.

EDUCATION:

Southern New Hampshire University

M.Sci. in Organizational Leadership

BS in Business Studies

Boston University, Metropolitan College

CRA Certificate Program, B.S. Program in Biomedical Technology & Laboratory Sciences

Aquinas Junior College, Milton, MA

Associate Degree, Science; Certified Medical Assistant, Administrative/Clinical

EXPERIENCE:

April 2014 – Present – Independent Consultant

Consulting/contracting services for various biopharmaceutical companies and service

organizations in the areas of strategic study management, operational excellence, project and

program management, clinical quality and compliance, clinical operations, etc.

February 2013 to April 2014 – AbbVie Inc. (Post-split restructuring; return to Boston area for

family health reasons)

Senior Director, Clinical Business Operations and Transformation

Responsible for Clinical Planning and Resource Management, Clinical Systems

Management, Compliance Standards and Training, Strategic Start-up and Patient

Recruitment and Retention, Pharmaceutical Development Communications, Vendor

Strategic Partnership Management, KPIs Metrics and Predictive Analytics,

Transformation Program Office

Developed 5-year strategic improvement plan to drive productivity, efficiency, cost

savings, improved cycle times, and drive organizational cultural change and pipeline

advancement.

Established cross-functional R&D Transformation Program Office with R&D Executive

Leadership to engage and align on innovation, define and implement strategic goals and

program execution

Established Compliance, Standards and Training department to drive quality initiatives

for inspection readiness; SOP and process redesign and harmonization; and staff

development and performance enhancement

Developed project management infrastructure for cross functional R&D core teams to

execute improvement projects to improve cycle times, processes and deliver clinical

programs

Financial and resource management for internal (~$25M) and study (~$5B) budgets,

strategic sourcing, and financial reporting (internal, Sunshine Act, SOX, etc)

Established centralized start-up and patient recruitment function to improve efficiency,

accelerate study timelines

Leadership of R&D Strategic Transformation Team for key initiatives including systems

integration, Centers of Excellence for Business Analytics, Portfolio level resource

projections, Transcelerate Biopharma initiatives ( investigator database, risk based

monitoring, site qualification and training, change management, etc.) Geographic

Strategy and Strategic Partnership Management.

May 2012 to February 2013 – Vertex Pharmaceuticals

Senior Director, Clinical Development

Responsible for oversight and governance of clinical development operations including,

but not limited to, clinical quality and compliance initiatives, SOP governance, process

improvement/redesign and training for clinical development stakeholders.

Establish R&D Training and Development Function to evaluate and enhance clinical

training modules and opportunities internally and externally to drive to higher

performance and accountability internally, at sites and partners

Establish Clinical Compliance and Risk Management function to collaborate with

relevant functions to assess audit and risk identification processes to enhance overall

performance, drive scalable and sustainable change; develop and maintain strategies to

achieve a state of compliance and inspection readiness.

Facilitate broad based quality initiatives and engage external parties and agencies where

applicable

Clinical Planning and Performance – Data Warehouse development, Key Performance

Metrics, clinical systems, business analytics, financial and budget development,

management and tracking

Strategic Sourcing – Outsourcing strategies across all of GMDA for all vendors and

functional service providers; establish strategic partnerships, develop internal and

external, long and short term resourcing strategies.

October 2011 to January 2012 – Biogen Idec Hemophilia (position discontinued in

restructuring/integration process)

Director Clinical Development Operations

Global responsibility for operational execution of clinical development programs and

studies, with integrated timelines, reporting and budget management to meet corporate

milestones

Directs and implements action plans for improvements within the Global Clinical

Operations department and across R&D functional lines

Develops and drives strategies for the selection, negotiation, and monitoring of

outsourced service providers to facilitate the achievement of corporate and department

objectives (time, quality, cost)

Ensures departmental compliance with GCP, regulatory and other applicable standards

and guidelines.

Integrates Clinical Business functions and other Clinical Operations functions (i.e.,

Medical Writing, Data Management, Biostatistics and Programming) ensuring alignment

and harmonization across disciplines.

Primary focus during short tenure was to drive inspection readiness for the successful

submission of two planned BLAs.

June 2007 to October 2011– Novartis Vaccines & Diagnostics

Jan 2008-October 2011 Global Head Clinical Trial Governance and Execution

Leadership of Global Clinical Trial Operations function - responsible for oversight of

clinical trial execution, clinical supply chain management, vendor selection and

management, clinical compliance, cross-regional process harmonization, operational

excellnce

Direct line management for operational functional heads; functional management

globally for operational execution of all clinical trials

Operational Executive for Trial Allocation Board including region/country, resource and

budget allocation and management; Chair of Trial Review Committee for ongoing

review of trial execution and risk management

Established infrastructure for project life cycle management processes and procedures;

implementation of global operational infrastructure for clinical R&D programs

Clinical Operations Excellence workstream leadership for scalable process re-

engineering/improvement initiatives and best practices; Development and ownership of

clinical operations SOPs and processes

Establish harmonized matrix-based program and process, clinical trial team structure,

roles and responsibilities.

Translated broad organizational strategies and objectives into specific objectives and

action plans, utilizing data-driven and analytical approaches, including tools and

processes, to support strategic planning, decision making and problem solving.

Relationship management with internal and external key stakeholders, including

functional heads, senior management and vendor management; Clinical representative for

Global Expansion Project initiative

Lead and/or participated in inspection preparation for 3 FDA and 3 EMEA new product

approvals in 2009-2010

6/2007-1/2008 – Novartis Vaccines and Diagnostics

Director Clinical Operations Region Americas

• Leadership of Clinical Operations Region Americas (staff management, development and

training, operational infrastructure, resource allocation, clinical plans, budgets and

timeliness) to drive program management through development and lifecycle

management

• Establish matrix model for regional program and process team structure, roles and

responsibilities.

• Oversight of CRO and vendor selection and management,

• Manage relationships with key stakeholders, including cluster team members, functional

departments, key opinion leaders, investigators and management

9/2005 to 5/2007 – Bristol Myers Squibb Medical Imaging

Director, Global Clinical Operations

• Leadership of Clinical Operations department (staff management, development and

training, operational infrastructure, resource allocation, clinical plans, budgets and

timeliness) to drive program management through development and lifecycle

management

• Developed and implemented global operational infrastructure and project lifecycle

management for clinical research and development programs

• Developed clinical development SOPs, tools and processes; Collaborate with cross-

functional R&D functions to drive and deliver clinical trials.

• CRO and vendor selection and management, establishing preferred provider relationships

and effective vendor management processes.

• Oversight, development and execution of clinical development programs utilizing data

and analytical approaches, including tools and processes, to support strategic planning,

decision making and problem solving.

• Manage relationships with key stakeholders, including clinical team members, global hub

managers key opinion leaders, investigators and management with a service mentality to

achieve global stakeholder alignment

10/02 to 9/2005 Quintiles Transnational, Inc., Strategic Research Services

2003-2005 Director, Project Management,

2002-2003 Associate Director Project Management,

Project Director for several large Phase IIIB/IV projects in various indications

Development and management of client and investigator relationships

Manage cross functional teams (clinical operations, data management, biostatistics,

medical writing, pharmacovigilance)

Development and management of overall program and project development plan,

timelines, budgets, and resourcing to achieve program objectives and client corporate

milestones.

Direct, mentor and manage clinical staff, including six project managers, site

management and clinical trial monitoring staff.

Provide senior scientific and strategic support for clients and project teams

Provide leadership, direction, process and support for all project operational activities.

Global SOP Task Force Member – Project Management

Co-manage Boston office of QSRS

10/01 to 10/02 Antigenics, Inc.

Therapeutic Area Manager

Program Manager for key oncology, immunology and infections disease products;

Develop and manage overall program and project timelines, budgets, resourcing to

achieve program objectives and corporate milestones; Develop and implement program

and project process tools from program design regulatory submission

Line management of clinical staff, including global project managers, CRAs and clinical

trial monitoring staff.

Prepare clinical sections of required regulatory documents, including clinical sections of

the following: IND updates, safety reports, annual reports, final study reports, and

NDA/BLA filings.

Develop and facilitate multidisciplinary and international team communication plan

Interface with thought leaders and investigators for study recruitment and training,

program development and to build key corporate relationships

6/01 to 10/01 Ardais Corporation

Senior Manager, Clinical Data Acquisitions Group

Initiate and oversee the use of Ardais’ web-based clinical report forms (eCRF) software

applications to each partner institution.

Interfacing with senior investigators/medical directors, site coordinators, and data

abstractors at each site to ensure the quantity and quality of data flowing into Ardais.

Identify, hire, manage and work with local monitors, CROs, site coordinators and clinical

research associates/data abstractors at each partner medical institution.

Provide technical feedback to the Ardais software engineering group on systems

enhancement to improve the electronic CRF

Develop a short term and focused data collection strategy to avoid unnecessary delays

and bottlenecks in final information delivery

Millennium Pharmaceuticals, Inc.

5/99 – 6/01

Clinical Project Manager

Manage 60+ Investigator Sponsored Trials in oncology, bone marrow transplant in

oncology and autoimmune disease, renal transplant, islet cell transplant

Supported FDA and EMEA approved submissions

Management of Global Project Team for Clinical Development Plan; CRO management,

responsibility for all operational activities,

Oncology Core Team – multidisciplinary management; responsibility for all internal and

outsourced operational activities, Sponsor Designee for joint venture partnership

Protocol and CRF development, and initiation of three Phase 2 and one Phase 1 asthma

studies, managing all operational activities

SOP writing, coordination and training

1995-1999 Diatide, Inc.

1996.1999 Clinical Research Associate

1995-1996 Clinical Research Coordinator

IB, protocol and CRF development for Phase 1, 2 and 3 clinical trials for indications in

oncology, vascular medicine and infection; Arrange Investigator Meetings, conduct site

qualification, initiation, management and close-outs; Study drug shipments and

accountability; data collection, monitoring, query and resolution; Author and Review SOPs

CRO selection and management for all study activities ; Assisted with the preparation and

submission of two successful NDAs, Leader of Pre-Approval Audit and FDA Inspection

preparation and process, Assisted with the preparation of Briefing Documents for two

MIDAC meetings. Coordinate administrative and operational activities across all clinical

trial projects. Establish and maintain document control/central files management system;

SOP management and compliance

.

1987 - 1996 Quality Transcription Services

Owned and managed a medical transcription service

1993-1995 New England School of Business Services

Designed and instructed - Medical Secretarial/Assistant Program.

1979 - 1993 Office Manager/ Clinical Assistant, Administrator Coordinator/Medical

Assistant

Various positions, performed all administrative aspects of the front office and management of

office staff in both clinical and hospital settings. Performed clinical assisting duties including

direct patient care, outpatient clinical management and clinical laboratory procedures

Professional Associations

• Association of Clinical Research Professionals

• Drug Information Association

• American Association of Medical Assistants

• American Health Information Management Association

• Project Management Institute

Academic Affiliations

• Instructor – Boston University School of Medicine, Master’s Program in Clinical

Investigations

• Instructor/Module Director – University of Siena, Masters in Vaccinology Program –

Clinical Trial Operations module.

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