Douglas A. Jamieson Email & Phone Number

California, United States

Jersey City, Nj, Us

Mitsubishi Tanabe Pharma America Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), a research-driven pharmaceutical company with over 300 years of history. MTPA is committed to discovering and delivering innovative treatments for serious diseases, with a focus on improving patient outcomes and quality of life. MTPA's mission is supported by a robust pipeline of investigational treatments and a dedication to bringing significant therapeutic advancements to market.MTPA manages the research, clinical, regulatory, medical affairs, sales, marketing, and business development functions in North America.As Senior Director - Global Development Office (GDO), play a critical role in regulatory and clinical alignment, risk analytics, and the application of innovative tools and approaches to improve the probability of success for the clinical development process. Facilitate cross-functional collaboration, optimize regulatory strategies, and drive the integration of advanced analytics to improve decision-making and project outcomes.Regulatory and Clinical Integration and Alignment++ Advance the progress of MTPA drug development projects and initiatives.++ Optimize global R&D priorities to ensure alignment with MTPA strategic objectives.++ Perform risk analytics, analysis, and evaluations of global MTPA projects.++ Exercise due diligence of AI/ML innovations and partnerships.

Greenwich, Ct, Us

Provide cross-functional team management, collaboration, and facilitation of complex projects, initiatives and activities to biopharmaceutical companies dedicated to discovering, developing and providing novel therapies to improve the lives of patients with unmet medical needs. Skilled in overseeing the planning, operation, execution, and completion of critical projects in product development, clinical trials, and research initiatives. Foster effective communication and collaboration between cross-functional teams, including Preclinical, Clinical/Medical Operations, Regulatory, Quality, TechOps (CMC), Data Management, Business Development, and Commercial. Influence and partner with functional leaders and teams, successfully aligning objectives, resources, and timelines, resulting in optimized resource allocation and reduced project timelines.Collaborate with Regulatory Affairs and Quality Assurance (RA/QA) to plan and track the preparation and review of documentation for regulatory submissions, including INDs and clinical protocol amendments, ensuring compliance with regulatory requirements. Provide transparent and accurate project updates to executive and senior management, showcasing effective communication and presentation skills.Utilize project management tools to develop and manage integrated project plans, ensuring adherence to established timelines across the projects. Identify and mitigate project and regulatory risks to implement contingency measures and ensure successful project execution.Drive implementation of best practices across programs. Collaborate with stakeholders to refine project management frameworks, methodologies, and standards while actively driving the adoption of tools and technologies to enhance project planning, execution, and reporting capabilities.MBA Finance and MS Engineering degrees; Project Management Professional (PMP)®.

Mountain View, California, Us

SanBio, Inc. regenerative medicine advanced therapy (RMAT) cell-based products focus on neurological disorders in various stages of research and development. FDA has granted RMAT Designation of lead cell therapy for treatment of chronic neurological motor deficits secondary to traumatic brain injury (TBI). The designation is based on clinical results of SB623 including Phase 2 Study of Modified Stem Cells in Traumatic Brain Injury (STEMTRA) trial.Regulatory Affairs++ Managed cross-functional team charged with completing Japan regulatory submissions (PMDA) securing approvals for all research and clinical sections in the Japan Biologics License Application (BLA).++ Formulated strategy scenarios for regulatory pathways under FDA RMAT designation; coordinated FDA interactions and meetings to facilitate regulatory approvals.++ Executed plan for CMC regulatory and device delivery submissions, ensuring compliance with FDA requirements and combination product regulatory pathway.Global R&D++ Led and managed cross-functional teams across Research, Clinical, CMC, and Regulatory/QA (Clinical, CMC, Device Delivery) to drive outcomes to support PMDA/FDA interactions.++ Implemented integrated project plans, optimizing team efficiencies and partnerships for development of cell therapy products to achieve key clinical milestones for Japan BLA filings.Clinical Development & Operations++ Oversaw work of contract research organization, external service providers, and suppliers directly involved in the drug development process.++ Framed clinical strategic and operational issues, enabling informed decisions, project status, issue resolution, and scenario planning.Finance & Corporate Planning++ Consulted with Finance on annual budget forecasts, optimizing financial planning for R&D and regulatory activities.++ Partnered with Finance and Corporate Planning to support long-range corporate forecasts for pipeline development, aligning business objectives with financial goals.

South San Francisco, California, Us

Provided management and nonclinical regulatory advisory (contract) to company discovering and developing drug candidates that play key roles in the control and regeneration of many essential organs and tissues, with potential for treatment of degenerative diseases and tissue injuries. Advised on input and content for research, regulatory, and production strategy plan, ensuring alignment with IND-enabling activities and regulatory requirements.++ Collaborated with research team leaders to develop in-vivo study plans, timelines for non-GLP toxicology, and nonclinical efficacy/dosing studies, ensuring efficient and timely execution of IND-enabling data.++ Developed CMC/PD (Chemistry, Manufacturing, and Controls/Process Development) timelines, including lead-time requirements, for gene synthesis sequences, contributing to seamless first production runs.++ Articulated written strategic plan decision scenarios, assisting company in making informed decisions during lead candidate selection to highlight regulatory implications and prioritize IND-enabling projects.

Irvine, Ca, Us

Provided expert-level, value-driven program management, business analysis, and project execution services to industry-leading global Fortune 500® companies in biopharma and technology. Provided acquisition integration management and execution across infrastructure. Enabled market-leading portfolio through strategic acquisition integration and change management.RGP is recognized by Forbes on its list of the World's Best Management Consulting Firms for its role in helping organizations throughout the world adapt to some of their biggest challenges.Expertise: Project Planning & Execution; Business & Team Performance; Business Strategy Implementation & Execution; Business Analysis & Risk Management; Problem Identification, Isolation & Resolution; Corporate Development Integration and Organizational Change Management; Communication Strategy, Plans & CorrespondenceBusiness Specialties: Program and Project Management Office; Business Transformation and Change Management; Corporate Development Integration; Strategy, Marketing & Branding; Regulatory Compliance; Information ManagementCorporate Development - Integration Change Management++ Execute business change management and corporate development integration strategy to successfully integrate acquired employees, products, services, operations, systems, and processes.++ Execute faster, more effective integration of acquired companies by building continuous development of integration expertise and applying integration best practices.++ Assist senior leaders achieve business readiness for organizational change management initiatives, generate accurate reporting to senior management, including identify and measure acquisition synergy/value.++ Provide guidance to Business Relationship Owners to conduct efficient integration activity throughout company and deliver on performance monitoring objectives.++ Successful integration and optimization of strategic acquisitions for enterprise and consumer business units.

Waltham, Ma, Us

Provided program management and core team leadership to Project Management Office of industry-leading, multinational, biotechnology product development company. Led core team collaboration with key OEM partner (Roche), stakeholders and business functions including Strategic Business Development, Quality & Regulatory, Supply Chain Management, Manufacturing and Finance.++ Identified, documented and communicated project risks and contingency plans through robust project management: tracking and communicating project status, key milestones, plans, issues, timelines, action items and budgets.++ Contributed to development and continuous improvement of Program Management Office processes, related SOPs, and supporting materials including business collaboration agreements, development plans and timelines.++ Oversaw and coordinated the work of key external partner and supplier (Roche) directly involved in the success of the product development process.++ Collaborated and coordinated with Business Development group to prioritize and start executing key business collaboration agreement with Roche to ensure partners’ business requirements were translated into achievable deliverables.++ Developed and communicated clear project goals, concrete actions, and compelling business case describing financial impact, importance for the business, feasibility, and complexity of implementation and risk management.++ Rolled-out technology integration tool with PMO that enhanced project coordination and efficiency, and increased transparency of project performance metrics and communication with senior management.

Morristown, New Jersey, Us

Directed project management of global biopharmaceutical company cross-functional core project teams responsible for strategy execution of global drug development and commercial programs.++ Provided program, project and operational management expertise across all drug development phases (preclinical to commercialization) to successfully drive strategic planning and execution.++ Developed project team system infrastructure to operationalize team high performance, effectiveness and efficiency, i.e., technology (MS Project, SharePoint), resource allocation (FTEs & budget), goal prioritization & schedule (key milestones/critical path), and communication plans (dashboards, KPIs, metrics) to executive team.++ Enhanced program management role to enable effective implementation of global Program Management Office (PMO) for drug development and commercialization related activities.++ Implemented comprehensive strategic plan to support corporate goals; executed against plan to enable successful and timely completion of team objectives and milestones.++ Collaborated with Preclinical, CMC, Regulatory, Clinical Development/Operations, Medical Affairs and functional areas to develop plans and regulatory submissions to move program forward.++ Created and drove timelines; identified program risks, issues, and deviations from plans; aligned with senior management and finance department to track project budgets and resourcing needs.++ Communicated with project team to ensure each team member is aware of both individual and team responsibilities and deliverables and that team members follow through on execution.++ Aligned outputs across key functional areas including facilitating Regulatory filings and protocol development for FDA briefing package content, filing strategy and timelines for IND submissions.++ Ensured collaborative and productive team meetings; prepare and distribute team meeting agendas and minutes; and identify action items and manage program execution.

Foster City, Ca, Us

Provided project management, best practices implementation and PMO advisory to industry-leading biopharmaceutical company, including management and leadership for key organizational and cross-functional initiatives developing and executing solution strategies to enable business operations.Clinical Operations PMO++ Designed, implemented and executed effective Project Management Office and business process improvements for Clinical Operations organization and study management teams.++ Provided project management for the executive-sponsored Study Management Team (SMT) Working Group driving goals to enhance execution of SMT start-to-finish study delivery.++ Led, facilitated and drove SMT Pilot Program sub-team to implement and execute high performance team management & leadership with SMT study leads and cross-functional members.Pharmaceutical Development & Manufacturing++ Drove identification of viable short/long-term business & technology solutions to enable Gilead’s ability to scale business operations by leveraging partnerships and expertise.++ Promoted solutions to Gilead leadership and senior management; led and facilitated project team meetings, leadership workshop and key stakeholder interactions (Lab Information Systems, Analytical Development, IT Quality Security) to successfully complete milestones and deliverables.++ Interfaced with impacted stakeholders, senior management and leadership to align expectations, provide project updates and solutions towards resolution of challenges and issues.++ Developed all Project Management Office documentation, including: project plan & schedule, change management communication plan and dashboards. Managed project risks, actions, issues, decisions, and resources to meet deliverables. ++ Managed execution of the project, including assigning and tracking project staff assignments, managing project scope and ensuring the quality of deliverables.

South San Francisco, California, Us

Assisted Regulatory CMC Program Management group with design, development, and execution of Program Management Office (PMO), including project management services, advisory and best practices support to regulatory management, leaders and teams on products for global market applications, life-cycle activities, and key departmental and cross-functional initiatives.++ Partnered with PMO head, Regulatory CMC group leaders and senior management; facilitating team interactions to enable successful delivery on agreed objectives.++ Identified and implemented effective processes, methodologies, and tools to promote and develop high performance organizations and teams.++ Collaborated with Regulatory CMC team leader and members to coordinate updates, ensure accurate input to activity timeline, and communicate regulatory activities.++ Managed team meetings: prepare agendas, meeting minutes, and track action items; assist with preparation of project summaries, dashboard updates and communication for management.++ Ensured product information flows between team members to enhance communications, informed decision making, and optimal alignment of technical regulatory goals and deliverables.

Wayne, Pa, Us

Provided subject matter expertise for a national professional services firm focused on strategy execution of complex situations through applying proven project delivery models and designing custom solutions. Supported corporate development integration by facilitating alignment of new company strategies with operations executing organizational change and optimization activities across global functional areas.Execute activities across global functional areas through integration completion; drive work stream schedule, analyze impact and devise solutions; facilitate and manage project meetings, agendas and actions; execute communications plan and manage team collaboration site; identify, manage and report risks, issues and decisions.++ Led project management of 10+ member Site & Infrastructure Technology Enablement (SITE) team successfully integrating 18 sites (domestic and global) into corporate portfolio.++ Aligned SITE execution with employee enablement model for acquired business. Integrated and transitioned processes and policies to environment enabling full site operations for acquired employees and teams. Successfully transitioned workstream execution activities to run the business.++ Identified and promoted project management lessons learned and ideas for continuous improvement in future deals; communicated recommendations for implementation in process improvement reviews.

Raritan, New Jersey, Us

Provided key project management to joint Alzheimer Immunotherapy Program with Pfizer in support of cross-functional work stream priorities on alliance initiatives for lead compound bapineuzumab subcutaneous to treat Alzheimer’s disease, including Joint Clinical Team; PFS/Device Strategy Work Stream and Dominantly Inherited Alzheimer Network (DIAN) Alliance Team. Inform, advise, and assist Senior Director of Project Management Office on enhancing team performance effectiveness and knowledge management capture efforts.++ Led high-level timeline development for DIAN Alliance Team (J&J, Janssen, Pfizer) to align Clinical Operations, Safety Monitoring, and Regulatory approach with clinical trial plans and timing.++ Facilitated strategic decision and scenario planning session with VP of Neurology and Alliance partner to convey DIAN business rationale and chart strategic path forward.++ Assisted senior management to prioritize and catalogue affiliate-wide post-hoc statistical analysis, rationale, timing, and resource allocation needs for future portfolio investment.

San Diego, Ca, Us

Provided leadership, management and oversight of R&D Integrated Project Plan for US and global cross-functional transition activities to ensure full responsibility is regained from collaboration with Alliance partner for novel diabetes therapies: Bydureon (exenatide extended-release for injectable suspension), Byetta (exenatide injection) and related products from its collaboration with Eli Lilly & Co.; identify, mange, and communicate project risks and assumptions, track project progress, report status to senior leadership and create points of contact to facilitate all communication / requests.++ Created comprehensive Integrated Project Plan incorporating 9 cross-functional, interdisciplinary, work stream plans to align and execute on corporate transition strategy to and leading up to acquisition by AstraZeneca.++ Managed and facilitated cross-functional planning and implementation of project to achieve all US and global near-term contractual deliverables regarding collaboration with Alliance partner [28 milestones / deliverables (~60%) completed within first quarter of project start].++ Identified and facilitated collaborative connections among work streams/functions (e.g., Contracts, Call Centers, Clinical Studies, Data Sets/Programs, R&D Document and Samples Transfer, Global Safety, Regulatory, Medical Affairs, and CMC) ensuring integrated strategic planning and execution between interdependent teams.++ Implemented High Performance Leadership framework realizing immediate improvements in team leadership, communication, and engagement.

South San Francisco, California, Us

Provided key project leadership to Device Development organization in support of business, functional, and administrative priorities, including: External Interactions Steering Committee for Devices; Device Testing Laboratory Workgroup, Global Device Platform Team; Global Technology Monitoring; Global Device Laboratory Alignment; and Test Method Optimization.Aligned and directed activities for cross-functional teams in the Device and Delivery Key Focus Area (KFA) while supporting business analysis on KFA team projects, including resource planning and tracking, performance monitoring, and risk management. Collaborated with KFA teams on issues, prioritize activities across multiple areas, and communicate project status/recommendations to senior management.++ Influenced focus as key contributor to team for completing global combination product business process (mapped to drug development as key guidance to Technical Development and Device Teams). ++ Executed kick-off of External Interactions Steering Committee for Devices that successfully developed influencing strategies to ensure company's global recognition as an industry leader.++ Managed short-term strategy and implementation project plan for clinical release/stability testing for Pre-filled Syringe (PFS) and PFS with Needle Safety Device for a Genentech molecule project team. ++ Served as key strategist and contributor to Device and Delivery Key Focus Area initiative, assisting with completion of 6 KFA Team Project Charters subsequently approved by VP of Pharmaceutical and Device Development.++ Provided expert-level guidance and support to KFA teams in preparation for executive-level presentations to key stakeholders of Device and Delivery KFA Steering and Executive Committees.++ Designed and managed communication plans and campaigns to inform global stakeholders of developments and accomplishments regarding internal change initiatives, projects and work streams.

Emeryville, Ca, Us

Provided results-driven project management, business analysis, and strategic advisory services to a small clinical-stage biopharmaceutical company, which develops innovative products for the treatment of infectious and respiratory diseases. Contributed to strategies, revisions, and submittal of “Adjuvant Development Program” proposal to National Institutes of Health to advance novel class of vaccine adjuvants towards licensing for human use.++ Recognized as key contributor to revised, 5-year, $17 million “Adjuvant Development Program” proposal to NIH. Wrote technical and business proposal “lessons learned” documents.++ Addressed 60 NIH questions and delivered a standout proposal within critical two-week deadline to win contract; established a new best practices approach to use with future funding proposals; and improved cross-functional communication and collaboration within organization.++ Developed matrixed technical and cost requirements against NIH research and technical objectives ensuring company’s key activities and deliverables were aligned with NIH expectations.

Reston, Va, Us

Planned and directed full cycles of projects across multiple functional areas, leading 5 core team members and 3 support personnel in meeting project milestones and goals. Prepared comprehensive communications and project plans, coordinate multiple activities, manage subcontractors and workforce, and develop progress reports for upper management, clients, and stakeholders. Managed annual budgets of $1 million. Worked jointly with all team members to address and resolve issues. Business Analysis and Strategy++ Implemented quality assurance process reducing variations in work product and improving project efficiency by minimizing re-work. Shortened project duration by two months, reducing costs to client by $150,000 while achieving greater accuracy in overall information conveyed to client.++ Evaluated and assessed business operations and environmental systems (natural gas extraction units; particulate removal unit operations) for clients in the integrated energy sector, ensuring full compliance with all applicable regulatory requirements.++ Implemented innovative strategy for aligning core team competencies with the mission of the company by executing a collaborative business model, enabling cross-functional sub-teams to successfully integrate both technical and non-technical work flow requirements for the client.Training & Development++ Recommended inclusion of project technical lessons learned process within senior staffing meetings, with suggestion subsequently adopted. Identified opportunities for staff development, including direct communications with clients increasing cooperation, motivation, and communication among project stakeholders.New Business Development++ Prepared proposals, evaluated and identified new opportunities.++ Contributed to capture of $25,000 data management evaluation contract through strategic business development and marketing project. Played key role in securing consulting contract with major integrated energy company.

Developed and implemented marketing and communication strategies to promote company as leading provider of patented systems using innovative plasma energy technology solutions to generate power, hydrogen, and other chemical products. Conferred with customers and representatives to evaluate solutions; contributed to marketing materials, web site, and technical presentations. Promoted cross-functional collaboration between marketing and engineering departments.Developed and coordinated Environmental, Health & Safety Program to treat various waste streams including medical and infectious waste. Co-created operating procedures for alternate problem solutions; evaluated system capabilities, manufacturing challenges, and economic trends in creating strategies. Modified program to communicate areas of responsibility, personnel requirements, and procedures. Financial Analysis, Strategy and Project Life-Cycle++ Developed economic value model to evaluate financial and marketing feasibility of project to enable data-driven business strategies and decisions to maximize ROI to customers.++ Successfully conducted break-even financial analysis for commercial scale-up and determined 10 ton per day or greater capacity systems could be built cost-effectively.++ Collected project cost data and assisted with economic and financial analysis of system to evaluate cost projections over the project life cycle. Successfully determined 3-year payback period to recover total project costs.Operations++ Created and implemented EnerSol Technologies’ Regulatory Compliance Program, negotiating with regulators and obtaining all system operating permits in less than 6 months.New Business Development++ Played key role in securing strategic business alliance agreement with major integrated energy company by authoring and executing business, marketing and communication plans for new business development projects under the U.S. Department of Energy Clean Fuels Program.

Functioned as national technical point of contact for compliance assistance activities affecting the commercial services sector. Developed guidelines and strategies for use in compliance assessment and assistance plans; provided recommendations for new guidelines to agency HQ, regional representatives, and engineers. Interpreted legislation to determine impact on commercial services sector. Represented agency at high-profile conferences and meetings. ++ Earned Achievement Award for demonstrating industry-based technology and quality management initiatives, with projects successfully received by participating businesses and completed within 1 year and projected cost ($100,000 budget).++ Recommended field testing and implementation of on-site compliance assistance program for businesses participating under the Compliance Assessment Guidance initiative.

Bachelor Of Science (Bs), Chemical Engineering

Master Of Business Administration (Mba), Finance, Strategic Management, International Business

Master Of Science (Ms), Engineering

Education record

Education record