Nick Brattan Email & Phone Number

• Drive clinical supply activities for both on-going and new clinical trials. This includes demand forecasting, trial monitoring & resupply planning, label design, packaging vendor management activities, IRT set-up and.
• Manage label development and production planning / operations with established CMO vendors
• Partner & build relationships with Clinical Research Organizations (CRO’s) for effective utilization of drug supply materials
• Work collaboratively with Clinical Operations, Quality Assurance, CMC and Regulatory Affairs to efficiently deliver clinical supplies as needed while ensuring compliance to all applicable laws and regulations
• Support both Program and Protocol level leadership across all functional areas and levels of the organization
• Develop risk mitigation plans to proactively identify any potential issues that may impact drug supply

Lexington, Massachusetts, United States

• Managed clinical supply packaging, labeling, and distribution for multiple clinical studies
• Maintained a continuous supply of clinical material, providing monthly reports, spreadsheets, and dashboards outlining current clinical supply levels to senior leadership
• Maintained robust long-range demand forecast and supply plans, based on study and program requirements
• Acted as the project lead for CMO partners, ensuring thorough oversight of manufacturing execution while maintaining strong partnerships
• Liaised with Clinical Operations, Clinical Development, QA, and CMC colleagues to support critical development milestones, while always ensuring on-time delivery of drug to patients in accordance with GCP regulations
• Prepared and actively managed program budget and purchase orders for multiple clinical programs

• Managed and led both internal and external project teams through manufacturing and development of multiple clinical stage antibody drug conjugate oncology therapies
• Established and drove project timelines and action items, while ensuring effective communication to senior management by articulating project progress and key milestones
• Built and fostered strategic vendor relationships, acting as the central point of contact for project communication, while aligning project progress to the overall program goals
• Identified and removed roadblocks to allow the cross-functional team to execute project deliverables within the established timelines

Manchester, New Hampshire, United States

• Managed the marketing team and created strategies for expanding market reach and growing business
• Developed and regularly reported overall marketing budget to senior management
• Led meetings with leadership to align business operations to the overall business strategy

Waltham, Massachusetts

• Managed a budget of $4M dollars on a pipeline product through FDA approval and product launch
• Defined and implemented detailed project plans, requiring cross-functional collaboration between Technical Operation SMEs, Quality Assurance, QC, Regulatory CMC and external vendors
• Identified potential risks to schedule, scope, resources, or budget and through judgment and application of project management expertise, suggested and drove resolution
• Facilitated management of critical project issues and risk mitigation strategies in real time by employing complex problem solving techniques
• Developed regular status updates and presentations on issues/risks/mitigations to be shared and/or presented to many senior levels of the AMAG organization
• Determined when issues or risks required escalation within the project team or to executive leadership

Waltham, MA

• Managed the RFP, installation, qualification, and validation of serialization software that met regulatory needs for the pharmaceutical industry
• Partnered with external project and site leads to verify and validate software use cases
• Ensured project tasks were being completed within the established timeline
• Assisted in developing and managing communications (regular reporting of project timeline and spend vs. budget) to team leaders, project team members, and senior management

• My daily responsibilities included, but were not limited to:
• Identifying key project stakeholders
• Defining project requirements and milestones
• Working with senior stakeholders to formulate a strategic vision
• Communicating project scope to external stakeholders
• Documenting, tracking, and managing curriculum development

• This position required me to manage the course development process for the eLearning Team at Southern New Hampshire University. My daily responsibilities included:
• Managing the course development process, from concept to delivery, across cross-functional teams
• Providing direction and support to stakeholders to ensure projects were delivered on time and on budget
• Communicating project scope to third party Subject Matter Experts and maintaining strong working relationships
• Collaborating with curriculum team members to ensure project needs were met following sudden organizational shifts
• Researching workflow software to provide more effective communication within a cross functional environment, while improving efficiency throughout the course development process

Manchester, New Hampshire

This position required me to have specific knowledge about the functionality of Blackboard and the Southern New Hampshire University course model. Through a collaborative passion for success, I worked on a team that ensured each course was built with exceptional quality and instructional clarity.

Master Of Business Administration (M.B.A.), Project Management

Bachelor Of Applied Science (B.A.Sc.), Business Administration And Management, General

Activities and Societies: 3 years of Alternative Spring Break

Master Of Business Administration - Mba, Project Management