Mike Bracken

Results-driven and seasoned professional with 35+ years of experience in delivering technology solutions and products/applications to customers in diverse industries, including high-tech, Internet/eCommerce, medical devices, transportation/intermodal, recruiting, health care, retail, higher education and real estate. Experienced technical project and program manager who has a proven track record of successfully managing highly visible and complex projects through the product lifecycle (from planning through implementation and support) under the pressure of fast-paced, time-sensitive environments. Decisive, energetic, focused team leader/player who leads high-performing cross-functional teams through implementing change and improvements.

Exceptional interpersonal communicator who effectively interacts with clients and all levels of management. Creative thinker and analytical problem-solver with demonstrated ability to manage and lead. Dedicated, self-motivated achiever who is committed to success and adept at juggling multiple initiatives in a high-pressured environment.

Senior Technical Project Management Consultant - Takeda - Cambridge, MA

(2026-01 - 2026-07)

Served as a project manager on a large initiative to create a custom-built Data Review Center, which is the centralized platform for planning, managing, and governing Clinical Data Reviews under the Cross-Functional Data Review process. This system is integrated with elluminate to bring data review plans, review cycles, meetings, approvals, and attestations into a single, structured workflow, replacing fragmented and manual approaches.

• Managed the development team
• Created detailed project schedules and resource plans for the entire initiative
• Managed project resources and vendor resources for project execution activities, including QA and GxP validation activities
• Used ServiceNow to create and track change requests and release records for software releases
• Provided monthly/quarterly governance meeting presentations and weekly status reports
• Managed the SOW and budget
• Managed $1M+ project involving a core team of 10 people and extended team of 30 people using Takeda's SDLC methodology

Senior Technical Project Management Consultant - Alnylam Pharmaceuticals - Cambridge, MA

(2025-03 - 2025-10)

Served as a project manager providing consulting services within their IT PMO. Managed projects to support two large business-critical Phase 3 clinical trials set to initiate in Q2 2025. One project integrated the data between the CTMS and eTMF (GxP validated systems) to provide a scalable operational infrastructure.

The other project created dashboards to provide real-time visibility into trial execution. In addition, took part in a project for R&D to implement an ELN (electronic laboratory notebook).

• Created detailed project schedules and resource plans
• Managed project resources and vendor resources for project execution activities, including QA and GxP validation activities
• Provided monthly/quarterly governance meeting presentations and communications plan
• Provided weekly status reports including deliverables matrix
• Managed the project financials within the overall program

Senior Project Manager - The Bill & Melinda Gates Medical Research Institute - Cambridge, MA

(2023-11 - 2025-05)

Served as a project manager providing consulting services for the Pharmacovigilance team. Managed the implementation of LifeSphere Signal & Risk Management, an end-to-end drug safety platform that helps hundreds of pharmacovigilance teams around the world save time and effort, ensure future-proof compliance, and unlock deep insights from safety data.

• Created detailed project schedules and resource plans
• Managed project resources and vendor resources for project execution activities
• Managed project budget and quarterly forecast
• Provided monthly/quarterly governance meeting presentations and communications plan
• Provided weekly status reports including deliverables matrix

Senior Technical Program Manager - Takeda Pharmaceutical Company - Cambridge, MA

(2023-07 - 2024-12)

Served as an IT project manager providing consulting services for manufacturing, supply chain, and quality projects in Takeda's Vaccine Business Unit (VBU). As part of Vaccine Data Digital & Technology, managed various projects for Manufacturing, Supply Chain and Quality organizations. Specific projects included Advanced Analytics and Artificial Intelligence, CMO Network Expansion and Discoverant.

• Created detailed project schedules and resource plans
• Managed project resources and vendor resources for project execution activities
• Managed project budget and quarterly forecast
• Provided monthly/quarterly governance meeting presentations and communications plan
• Provided weekly status reports including deliverables matrix

Senior Program Manager - Exelixis Inc. - Oakland, CA

(2022-04 - 2023-06)

Served as a program manager for Exelixis, an oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers.

• Planned, coordinated, and managed program/project activities related to the Commercial Supply Chain roadmap
• Ensured execution of decisions and direction set forth by the Supply Chain Subject Matter Expert (SME)
• Maintained program/project risk mitigation plans
• Worked closely with IT business partners as necessary
• Executed oversight of implementation vendors

Senior Technical Project Manager - Agios Pharmaceuticals, Inc. - Cambridge, MA

(2022-10 - 2023-04)

Served as a project manager for Agios, a pioneering leader in cellular metabolism, advancing therapies for patients with unmet needs. Responsibilities included planning, coordinating and managing a SAS Office Analytics major software upgrade. This project involved resources from IT, Infrastructure, QA and Biometrics, and also involved managing the vendor who is performing the upgrade.

Senior Technical Program Manager - Calliditas Therapeutics - Stockholm, Sweden

(2021-02 - 2022-03)

Served as the IT program manager for Calliditas Therapeutics, a clinical-stage global biopharmaceutical company focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. As part of the PMO, managed all of the IT components of their first commercial drug launch in the United States. This included the implementation of many applications, including BI/Analytics (ZS REVO), CRM (Veeva) and Finance (Concur).

This was a $5M+ project involving a team of 30 people which also included vendors.

• Coordinated all IT activities related to the IT launch roadmap
• Maintained the IT roadmap in alignment with business roadmap
• Executed oversight of implementation vendors
• Drove readiness across business functions

Senior Technical Project Manager - Alkermes, Inc - Waltham, MA

(2020-05 - 2021-02)

Served as a Senior IT Project Manager for Alkermes on a variety of R&D initiatives, including the implementation of SaaS-based products Benchling (large molecule biologics) and Xybion (business process management), and a data platform that enables automated data collection and ingestion, file and data management, import frameworks and data processing.

Senior IT Program Manager - Momenta Pharmaceuticals, Inc - Cambridge, MA

(2019-08 - 2020-05)

Served as a Senior Project Manager for Momenta Pharmaceuticals on a variety of IT Infrastructure initiatives, including a migration of all company devices to Windows 10 and Office 365 and a change of telephony and collaboration solution to RingCentral & Glip.

Senior IT Program Manager - TESARO, Inc - Waltham, MA

(2018-08 - 2019-08)

Served as a Senior Program Manager for TESARO on a major initiative to replace their existing CRM system (MI) with Veeva CRM, which will be used by both the Commercial and Medical teams. It also involved the migration of data from the old CRM system to the new one, and the integration of their BI/Analytics platform (SHYFT) to their new CRM system. This was a $600K+ project involving a core team of 7 people and an extended team of 15 people using a modified Agile methodology.

• Oversaw and monitored inter-connected projects, which included the CRM customization, data warehouse integration and system integrations to the CRM system (Pharmagin, ProPharma, and Content Management System)
• Managed teams consisting of project managers, business and technical resources from TESARO and outside vendors
• Created and managed the overall program plan, which included application configuration, integrations, data migrations, testing and training
• Maintained the issues, milestones and risks for the program