Som T.
Head of R&D Program Management @ Eledon Pharmaceuticals, Inc.
About
Experienced Head of PMO, Strategy, and Business Operations with a proven track record of achieving strategic outcomes. Skilled in Financial Planning and Analysis; Project/Program/Portfolio Management; Personnel & Resource Management; and Continuous Improvement. Expertise in establishing a culture of accountability and urgency, supported by robust governance frameworks, business systems, operational processes, and reporting structures.
United States
Greater Boston
Biotechnology
Product Launch, Strategic Thinking, Project Engineering, Timeline Management, Budget Management, Oracle Enterprise Resource Planning (ERP) Cloud, Project Plans, Leadership, Budgeting, Strategic Project Management, Research and Development (R&D), Project Strategy, Large-scale Projects, Decision-Making, Multitasking, Regulatory Requirements, Commercialization, Performance Metrics, Project Portfolio Management, Creative Ideation
Experience

Head of R&D Program Management
Greater Boston
Responsible for planning pre-IND, IND, phase 1, 2, and 3 studies across CMC/Technical Operations, Clinical Operations, Safety, Biostatistics, Medical, and Regulatory departments. Lead governance for the R&D organization, ensuring initiatives and programs are appropriately prioritized, effectively resourced, risks are actively managed, and key decisions are clearly documented and communicated.

Head of Project Management Office
Greater Boston
• Developed and deployed project management methodology to manage project portfolio, prioritize projects, and drive timely delivery for launch and label expansion • Responsible for delivery of International Business Long Range Plan & year-over-year tactical planning • Lead project teams to deliver projects that span across different areas within International Business Unit, Market Access, Health Economics Outcomes Research, and Real World Evidence departments • Responsible for leading PM organization (i.e. personnel goal setting, career development and leading team of Project Managers) • Ensure effective executive level communications on project performance (schedule and budget)

GMA - Head of Business Operations, Neurology
Greater Boston
• Manage operational rhythm for Neurology Global Medical Affairs team including but not limited to monthly accruals, rolling budget updates (i.e. LRP, forecasting, reforecasts, etc.), goals updates, and business reviews. • Lead tactical lifecycle management (Mid Term Planning, Annual Operating Plan, Annual Needs Assessments) to ensure strategically aligned tactics are planned and budgeted then applying change control to ensure fiscal accountability while partnering with stakeholders. • Lead Financial planning, reporting, and performance analysis for business partners. • Coordinating GMA Leadership Team and Value SubTeam meetings; setting agendas, issuing minutes, and actions are documented and completed. • Support team members in leveraging internal systems (i.e. Smartsheet, Coupa, ARIES), and accelerating the procure to pay process (contracts, SOWs, MSAs, etc.). • Lead delivery of projects by engaging with global team members and stakeholders to ensure timely delivery while managing risks and ensuring a high-quality product.

Head of Business Operations, Strategy, and PMO
Greater Boston Area
•Site Leadership Team member responsible for Managing Site Business Operations, PMO, Change Management facilitation, Communications, and Strategy setting. •Responsible for Site Performance Management including but not limited to setting goals, setting up reporting/ communication mechanisms and ensuring departments deliver on set objectives •Accountable for developing, compiling and issuing executive reports/communications; and accountable for reporting / presenting Scorecards; includes critical meetings e.g. Site Business Reviews •Responsible for: -managing and supervising cross functional teams in meeting Site project objectives (business case, charter, scope, schedule, cost, quality, risk, communications, etc.) -Managing Portfolio of projects to ensure alignment with corporate goals and Site needs. •Responsible for leading PMO/Business Operations organization i.e. personnel goal setting, career development and leading team of Project Managers •Responsible for Site communications (Town halls, all-staffs, and cascading communications)

Business Excellence - PMO | Business Operations | Value Stream Management | Chief of Staff
Social Circle, GA
•Site Lead for Business Operations (PMO, Business Operations, Value Stream Management, Chief of Staff), responsible for: - Coordinating and facilitating critical leadership / governance meetings; decisions management, reporting issues/impacts/action plans/performance (KPIs) and critical governance meeting management. - Responsible for working with Leadership in setting goals, setting up reporting/ communication mechanisms and ensuring departments deliver on set objectives •Accountable for generating, compiling and issuing executive reports/communications; and accountable for reporting / presenting Scorecards to Senior Leadership, Steering Committees on project / program performance. •As Business Operations and PMO Manager, responsible for: - Managing Scheduling organization for $1+ Billion program. Responsible for developing resource loaded schedule, managing reporting process and ensuring data integrity. - Leading Risk Management Life-Cycle for $1+ Billion program. Established System to ensure risks were identified, ranked/prioritized, categorized, mitigated and retired. - Managing Portfolio of projects to ensure alignment with corporate goals and Site needs. •Established and Managed Business Operations and PMO organizations for green field Site; responsibilities included personnel goal setting and development; setting and adhering to department budget, headcount and staffing plans. •Value Stream Manager for Warehouse, Supply Chain. Managed portfolio of projects to improve operations, and document annual strategic / tactical plan to obtain funding.

Project Controls Program Manager
Broomfield, CO
• Business system owner for Sandoz’s PM tool; this includes the standardization of the project management process, and continuous improvement. • Responsible for defining activities, determining resource needs, building schedules, identifying risks, conflict resolution and establishing communication strategies. • Responsible for resource load leveling (managing personnel assignments), tracking activity progress, and assigning priorities aligned with department, site and company vision. • Responsible for executing Capital Expense (CapEx)Projects ranging from $100k to $2.0MM related to Site infrastructure including but not limited to: roof replacement, flooring upgrades, GMP clean room upgrades. Including partnering with Procurement, Legal and others to define MSAs and Contracts. • Developed and delivered PM Program Tools to enhance project execution including standardizing PM processes. • Surveyed, studied, developed and deployed best practices for contractor on/off boarding, CAD management program, contractor time-card system and master project schedules. • Proficient with project and scope control, and financial business analysis [return on investment (ROI), net present value (NPV), and internal rate of return (IRR)] to meet corporate objectives. • Charged with enforcing fiscal responsibility within site organizations to manage budgets (> $50MM over 4 years). • Partnered with Finance to ensure contract resources are capitalized to minimize department expenses.

Project Manager/Lead, Quality Validation, Sr. Engineer
Boulder, CO
• Managed simultaneous schedules (project, finite plant and PMO), budget and resources (personnel and equipment) in delivering multiple new product introductions (NPIs) and product reintroductions (PRs) projects on time and within budget while meeting First Pass Quality initiatives. • Projects led: - Multiple NPIs: Unit Operations modifications and new systems installations; budgets ranging from $1.0MM to $1.4MM. - Multiple PRs: Processing system upgrades to existing systems; capital budgets up to $1MM. Reduced cost by $200k (20% of budget) by adjusting department resource allocations. • Responsible for: - identifying project priorities for cross functional teams to ensure milestones are met. - making presentations to plant and engineering leadership to obtain project resource and budget approvals as well as reporting project performance metrics to site leadership. • Experienced with managing engineering documents (e.g. SOPs, guidelines & best practices). • Implemented ASTM E2500 program for integrated commissioning and validation.
Som T.'s Contact Information
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