Scott A. Wolbach
Gilbertsville,USA
Summary
Dynamic leader with extensive experience at Bristol Myers Squibb, specializing in portfolio strategy and governance. Proven ability to drive regulatory compliance and enhance stakeholder management. Skilled in implementing process improvements and utilizing agile methodologies to optimize project delivery and foster cross-functional collaboration.
Overview
19
19
years of professional experience
Work History
Associate Director, Strategy & Project Planning/Portfolio Mgt.
Bristol Myers Squibb
Tampa, FL
06.2017 - 12.2025
- Led portfolio delivery by supporting planning and managing development programs in Oncology, Cardiovascular, Neuroscience, and Autoimmune areas, enhancing execution and milestone timeliness.
- Led strategic R&D project planning/execution, driving complex initiatives that accelerated development and delivery.
- Partnered with Global Clinical R&D stakeholders to strengthen SOP/process compliance and delivered targeted training that improved regulatory inspection readiness across the team.
- Optimized resource allocation with Capability Steward, enhancing timeline discipline, risk management, and data quality standards to improve project execution.
- Advanced project planning capability by applying best-practice methodologies and providing feedback and coaching, accelerating staff development and improving team performance.
- Mentored four project managers to enhance their leadership skills and improve project delivery.
- Built cross-functional partnerships across project teams and departments, enhancing alignment and decision-making to achieve project goals.
Clinical Operations Manager II
DePuy Synthes, Johnson & Johnson
West Chester, PA
07.2016 - 06.2017
- Led change-management initiatives to harmonize Clinical R&D processes, enabling efficient execution of clinical studies, including PMA Class I–III medical device trial activities.
- Strengthened regulatory compliance by collaborating with Global Clinical R&D associates to standardize SOP adherence and provide targeted training, enhancing team inspection readiness.
- Delivered KPI dashboards and executive-ready reports by leading metric collection and reporting, facilitating informed decision-making and strengthening compliance execution.
- Supported New Product development projects, ensuring operational excellence, regulatory compliance and on time delivery.
- Built multigenerational portfolio plans aligned to company strategy and partnered with Product Development, Engineering, and Lab teams to support product design and drive on-time launches.
- Provided cross-functional governance for Clinical R&D across global medical device and pharmaceutical organizations, enhancing alignment and execution within the Global Orthopedic Group and Global Surgery Group.
Integrated Project Manager
Almac Clinical Group
Souderton, PA
11.2013 - 10.2015
- Led global clinical trials across Oncology, Cardiovascular, CNS, and Respiratory programs, integrating development plans (iDP) and drug supply planning to ensure compliant, high-quality, on-time execution.
- Accelerated regulatory delivery by proactively tracking required activities, milestones, decision points, and critical path items—surfacing risks early to keep submissions and approvals on schedule.
- Orchestrated cross-functional deliverables to support global regulatory strategy and coordinated with submission operations for timely, high-quality pre-submission activities.
- Protected study timelines by managing end-to-end execution (startup, site qualification/initiation, patient accrual, data management, and drug supply delivery), ensuring milestones were met.
- Strengthened trial execution and compliance by serving as primary liaison for vendor oversight, completing internal/external documentation per SOPs, GCP, and protocol requirements.
- Coordinated submission documents (IND, IMPD, NDA, BLA, MAA) for commercial filings to FDA and EMA, ensuring adherence to regulatory standards.
- Oversaw global clinical trials and drug supply planning, ensuring compliance, timely execution, and quality standards.
Project Manager/Lead
PJM Interconnection
Norristown, PA
11.2012 - 07.2013
- Directed project management and financial governance for large-scale energy utility contracts, ensuring timely delivery and budget adherence.
- Aligned cross-functional teams and stakeholders through scope and change control and risk management processes, ensuring project delivery met established plans.
- Supported 12+ external stakeholders with project plan changes, timeline management, and strategic planning, implementing cost controls to safeguard budget and delivery milestones.
- Built and delivered financial performance tools that improved stakeholder visibility into budget, spending, forecasts, burn rate, and profitability—enabling data-driven decisions.
Project Manager/Coordinator
Independence Blue Cross
Philadelphia, PA
01.2010 - 12.2012
- Partnered with Business Owners and IT stakeholders to deliver PMO strategic guidance and business-case analysis, facilitating informed go/no-go decisions on project viability and investment value.
- Delivered projects across the PMO lifecycle using both Waterfall and iterative methods, improving on-time execution across business initiatives and the IT project portfolio.
- Led project implementation/process improvements within healthcare insurance operations (PMO), supporting strategic goals.
- Rolled out PMO best-practice processes and developed standardized template repository (reporting tools and templates) aligned to Clarity, streamlining project reporting and ensuring consistency.
- Implemented structured change-management practices to ensure process adoption and secure required approvals; established KPI/metrics reporting to enhance transparency and governance.
Financial Planning & Analysis Manager
Roadlink Services, LP
Bethlehem, PA
01.2007 - 12.2009
- Directed financial planning, business development, and operational analysis to enhance organizational growth and operational efficiency.
- Aligned short- and long-term sales and financial objectives by securing stakeholder buy-in and achieving consensus on measurable goals and execution plans.
- Led, mentored, and performance-managed a 2-FTE finance team; redesigned a cross-functional budgeting process to accelerate budget completion by 3 weeks.
- Built the company’s first Customer Profitability Reporting System and led enterprise adoption, enabling management to increase margins by 5% across the top twenty accounts.
- Enabled 20+ rep sales organization by improving lead cultivation, managing proposal development, and implementing CRM and reporting processes.
Education
Master of Business Administration - Business, Financial Management, Strategic Planning, Organizational Leadership
St. Joseph’s University
Philadelphia, PABachelor of Business Administration - Financial and Business Management
University of St. Thomas
Houston, TXSkills
- Portfolio strategy and governance
- Strategic planning
- Stakeholder management
- Cross-functional leadership
- Change management
- Process improvement
- Agile and waterfall methodologies
- SAP and Oracle ERP
- Veeva and Clarity
- Cognos and SharePoint
- AI and Copilot integration
- Communication skills
- Relationship building
- Program development
- Decision-making
- Portfolio management
- Regulatory compliance
Additional Information
Open to travel 10-20% for project-related work., Open to relocation.
Key Areas Of Expertise
- Program & Portfolio Management
- Strategic Planning
- PMO Governance
- Cross-Functional Leadership
- Process Improvement
- Change Management
- Regulatory Compliance (GxP/GCP)
- Financial Planning & Analysis (FP&A)
- KPI Reporting & Dashboards
- Communication
- Relationship Building
- Stakeholder Management
Target Roles
- Senior Program Manager
- Project Management Director
- Portfolio Manager
- Strategy & Operations Leader
Timeline
Associate Director, Strategy & Project Planning/Portfolio Mgt.
Bristol Myers Squibb
06.2017 - 12.2025
Clinical Operations Manager II
DePuy Synthes, Johnson & Johnson
07.2016 - 06.2017
Integrated Project Manager
Almac Clinical Group
11.2013 - 10.2015
Project Manager/Lead
PJM Interconnection
11.2012 - 07.2013
Project Manager/Coordinator
Independence Blue Cross
01.2010 - 12.2012
Financial Planning & Analysis Manager
Roadlink Services, LP
01.2007 - 12.2009
Master of Business Administration - Business, Financial Management, Strategic Planning, Organizational Leadership
St. Joseph’s University
Bachelor of Business Administration - Financial and Business Management
University of St. Thomas