Douglas Baker Email & Phone Number

United States

Integral component of Jazz's Medical Operations and Effectiveness team as part of the Global Medical Affairs department and report directly to the Head of Medical Operations and Effectiveness. Will support the GMA Leadership Team in overseeing activities essential to the timely execution and tracking of Medical Affairs projects.

Gilbert, Arizona, United States

As an Oversight Director, accountable for strategic indication or client-specific portfolio management within a Therapeutic Unit; expertly navigates the need to dive in/ dive out of situations while ensuring the Project Lead remains empowered; provokes critical thinking in Project Lead related to execution of delivery, financial negotiations, prioritization; provides insight into proposal strategy in preparation for bid defense; works with Therapeutic Unit Head in development of business growth strategies; maintains awareness and engages as appropriate in the Contract Modification process; communicates with People Managers to support the development of employees; and provides expertise and perspective related to client needs, indication,and therapeutic knowledge.

Research Triangle Park, Nc

- Provides leadership and is accountable to mentor and support the work of professional staff and managers assigned in his/ her therapeutic area- Ensures compliant and profitable project delivery that meets or exceeds customer and industry standards- Ensures successful management and coordination of efforts to support milestone achievement and overall program delivery to the customer- Ensures adherence to program budget and scope of work to realize program profitability- Ensures all program tasks are completed in accordance with program plans and in compliance with standard Premier Research processes, policies and procedures- Ensures effective communication is maintained and program status reports are provided both internally and externally- Ensures adequate resourcing is available to meet program deliverables and milestones- Oversees and/or manages the program team to ensure program progress is according to client and Premier Research requirements and recommends and drives necessary courses of action to keep program on track- Oversees and chairs OMCs and Joint Steering Committees as key team member with customers- Actively contributes to cross-functional discussions both from a PM functional perspective, and a cross-functional strategic perspective- Monitors the health and growth of mission-critical accounts and provides support to the PM leadership for such accounts- Assists in the creation, development and nurturing of key strategic customer relationships- Recruits, develops, motivates, trains and retains staff- Assesses the performance of the core team members- Facilitates communication within the program and cross-functional teams- Evaluates program progress based on company tracking systems, program timelines and budget reviews provided by Project Management staff

Raleigh-Durham, North Carolina Area

- Owner for the operational strategy of New Bids and Bid Defense Meetings in the Neuroscience and Pain Therapeutic areas- First reviewer/approver for proposals as assigned by the Vice President and Member of Oversight/Operations Committees for assigned Customers- Render oversight to project managers and project directors for large multinational projects, while leading the activities of the Neuroscience/Pain therapeutic areas- Administer the profit and loss (P&L) of the company by reviewing large national or global projects/programs and complex projects in terms of customer and deliverables - Measure project progress, risks and trends using metrics and KPI approach to achieve project milestones delivery in the Neuroscience/Pain portfolio - Create action plans to minimize inefficiencies when recovery from the customer is not possible- Ensure PM/PD’s and team have all relevant strategies in place to maintain profitability through thorough review of financial projects, estimates cost to complete and timely execution of contract modifications for awarded projects- Monitor the performance of project leaders assigned to manage clinical research projects - Display efficiency in managing several projects simultaneously, which involved defining and overseeing project resource needs as well as implementing contingency plans for key resources- Create individualized career development plans and supports individual staff needs as appropriate while assessing PM/PD staff performance

Morrisville, Nc

- Supervision of project managers and senior project managers for large multinational projects, while leading the activities of a therapeutic area- Efficient handling of the P&L of the company through the evaluation of large national or global projects/programs and complex projects in terms of customer and deliverables- Proactive collaboration with various divisions in administering and delivering projects and program within cost, time, and quality requirements- Development of business processes to ensure uniform, complete, and appropriate instigation of tasks among cross-functional teams by working closely with management- Vital role as liaison on business development, bids and contracts, in support of client presentations and proposal development- Close monitoring of the performance of project leaders assigned to manage clinical research projects- Simultaneous management of several projects, which involved definition and oversight of project resource needs as well as implementation of contingency plans for key resources- Active communication with the senior management to convey all project-related matters- Strict compliance of all project deliverables with company and client expectations- Oversight of project expenditures, identification of potential efficiencies, and establishment of strategies in collaboration with the WCT Leadership Team, finance personnel, and functional group leaders, which led to the successful growth of clinical research projects profits- Attainment of design, implementation, tracking, and revision of project plans for all assigned projects

Morrisville, Nc

- Full responsibility as regional operations leader for AstraZeneca, in charge of directing the delivery of the global studies portfolio while working for the global MEOR team- Execution of all operational aspects of the CR comprised of feasibility assessments on study proposals as well as partnership with local AstraZeneca Marketing Companies- Performed continuous assessment on the appropriate compliance to ensure the success of each project- Accordance with all AstraZeneca procedural documents and international guidelines, such as ICH, GCP, and relevant local legislation during operations in outsourced environment- Provision of sound recommendations in planning for projects while ensuring proper execution of all proposed studies- Orchestration of specific projects to ensure the compliance of remits and deliverables with the agreed priorities across the portfolio as regional contact point to assigned ESP/CRO teams- Identification of the impact of new requests or project time, cost, and quality changes on deliverables by working within the ORC Team environment- Efficient delivery of projects within budget and with high-quality region-wide while guaranteeing the achievement of reliability and productivity goals of the Observational Research Centre- Assistance in evaluating ESPs; reviewing initial RFP; and selecting subsequent ESP agreement on significant out of scope changes and general high level issue management toward the attainment of the highest level of ROI- Enablement of exchange of information while maintaining support from AstraZeneca resources through the implementation of an effective communication plan between the ORC stakeholders and external providers- Successful completion of several assignments which included:o Global Diabetes Studies-Observationalo Oncology Registry–Food and Drug Administration (FDA) Mandatedo Oncology Pregnancy Registry-Safety Surveillanceo Oncology-PD-L1 Protein Expression

Durham, Nc

- Expert direction to the daily operations of Neuroscience Medicine (CNS) and Peri-operative clinical research projects- Facilitation of training to project leaders to ensure on-time and within budget completion of all assigned projects while adhering to all applicable regulatory requirements based on sponsor specifications- Escalation and resolution of all problems/challenges across all CNS and Peri-op projects- Engagement in several sponsor meetings in support of business development efforts while tracking the financial performance of all CNS and Peri-op projects- Effectual guidance to personnel to identify and hire a number of qualified investigative sites; establish effective strategies; and educate sites while increasing their enthusiasm and interest in CNS/Peri-op clinical research projects- Integral role as the resource for CNS/Peri-op Faculty and DCRI personnel to manage all aspects of the CNS/Peri-op clinical research- Development of a library of standard case report form (CRF) modules to guarantee consistency of data definitions across all CNS/Peri-op projects in partnership with the CNS/Peri-op Core Team members; while overseeing the aggregation and assessment of data sets from diverse projects- Completion of several CNS and Peri-op clinical research projects as delegated by the departments of Neuroscience and Anesthesia leadership- Improvement of site selection and performance through the application of key data elements in the investigator database for all sites participating in CNS/Peri-op trials while ensuring proper usage of metrics in collaboration with DCRI personnel- Keen assessment of audit reports and post-project debriefing sessions to determine diverse opportunities toward the development of the CNS/Peri-op clinical research projects- Significant increase of the profit of CNS/Peri-op clinical research projects by monitoring project expenditures, identifying potential efficiencies, and establishing strategies

Virginia Beach, Virginia

- Creation of proposal and budget development to comply with all customer and vendor outsourcing requirements- Collaboration with the client’s internal staff and independent consultants to guarantee timely project resourcing and project scope in regulatory, clinical, and quality management areas- Planning and oversight of clinical studies and related projects while guiding project teams to meet milestone requirements and deliver projects on time and within budget- Leadership to global product clinical development, regulatory, and commercialization along with assistance to pharmaceutical, biotech, and medical device companies in obtaining products from discovery through development while mitigating risk- Proactive support in managing clinical operations, which included setting up the Data Safety Monitoring Boards and Data Review Committees; integral role as the primary contact responsible for providing key safety data for review; as well as ensuring medical reviews of datasets- Determining and selection of team members to guarantee the successful outcome of each project- Optimization of processes and decrease of risk by providing strategic advice from early stage phase I through clinical development and commercialization- Enforcement of regulatory development, compliance, and quality systems solutions which significantly enhanced efficiency, minimized risk, and achieved commercial success

Rockville, Md

- Successful completion of all assigned studies in compliance with financial budgets, regulatory requirements, and internal quality standards by administering several operational activities of Phase I-IV studies while assisting in the establishment of departmental goals and standard operating procedures- Formulation of business model to provide the needs of sponsors as well as to implement innovative and creative ways to retain business by working with Strategic Planning Group- Spearheading of the establishment of new budget templates and financial systems- Provision of expert recommendations to the president/chief executive officer (CEO) of client matters as DP Clinical business plan- Compliance with budget guidelines and objectives in leading the planning and allocation of DP clinical corporate financial budgets- Delegation of staff and resources to achieve objectives and assess processes toward the enhancement of efficiency of service/operations- Establishment of a risk mitigation group to enable the assessment of projects for quality, timelines, budgetary needs, as well as potential risks and challenges- Delivery of significant growth of business opportunities with in-depth knowledge of external needs and internal capabilities

Silver Spring, Md

- Administration of the Phase I, II and Open-Label Extension clinical research trials with an inhaled prostacyclin for primary pulmonary hypertension as well as ensured the quality and consistency of Lung Rx services in accordance with all applicable regulatory guidelines, GCP/ICH, GLP, and SOPs through direct line management support- Proactive communication with the strategic planning group in developing various outcome scenarios to respond promptly to dynamic situations- Close monitoring of the maintenance and control of batch records and labeling for inhaled treprostinil sodium, encompassing 10 countries, including Austria, Brussels, Israel, Italy, France, Germany, Poland, Spain, United Kingdom, and the United States- Maintenance of the inventory for double-blind and open label study phases for TRIUMPH 1

Winston-Salem, Nc

Bachelor Of Science, Biology

Masters Of Health Administration

Masters Of Business Administration, Concentration In Health Care

Master Of Business Administration (Mba), Health/Health Care Administration/Management