Heather Sensi

• Thought partner to the Head of Innovation Strategy & Integration (ISI), a cross-R&D support function.
• Led workshops to develop the strategy, vision and roadmap for new ISI function in 2024, refreshed annually.
• Partner with finance to develop & manage ISI budget and HR to develop and oversee the People Strategy.
• Interim Head of R&D Learning and Development for 6 months.
• Develop and deploy departmental communications and engagement strategy.
• Create strategy & materials for department All Hands (virtual & face to face) and Leadership Team meetings.
• Drive cohesiveness & collaboration between ISI sub-functions, connecting the dots & identifying risks.
• Collaborated with cross-functional teams to develop and implement strategic initiatives.
• Prepared executive reports and presentations for senior leadership decision-making.
• Mentored junior staff, fostering professional development and knowledge sharing within the team.
• Facilitated strategic planning sessions to align departmental objectives with corporate strategy.
• Develop ISI Book of Work repository (Smart Sheet) and executive dashboard (Power BI).

• Established R&D KPIs, process for data harmonization and reporting, and established R&D portfolio intake & management process.
• Created and deployed Lean Six Sigma “light” training to Operational Excellence representatives in R&D.
• Developed and tracked ISI objectives and success metrics.
• Developed ISI Book of Work repository (Smart Sheet) and executive dashboard (Power BI).

ROLE: PMO Lead for Global Drug Development (GDD) Innovation Program:

• Provided strategic leadership to BMS’s Global Drug Development Innovation team (digital, data & trial design).
• Partnered with cross-functional team members to develop the innovation strategy and drive the execution of various Digital Health & Technology projects across multiple niche vendors.
• Prepared and facilitated quarterly sponsor reviews with the Executive V.P. of R&D and Finance allowing visibility of progress and prioritization of the next set of work.
• Executed process optimizations for the vendor onboarding process for innovation vendors. Process improvements reduced onboarding timelines by 2-3 months (50%).
• Maintained the portfolio of innovation projects and tracked KPIs & business value achieved.
• Managed $74M budget and executed annual and quarterly project prioritization to ensure budget for the most business-critical and high-value innovation projects.
• Conducted a Change Management Assessment for 26 innovation projects to ensure smooth deployment.
• Created the GDD Innovation SharePoint and authored monthly newsletters to the GDD organization.

ROLE: PMO Co-Lead for R&D COVID-19 PMO:

• Quickly identified and deployed strategies to continue the execution and viability of clinical trials globally during the COVID-19 pandemic. Ensured documents were compliant with local health guidance where deployed.
• Authored & maintained guidance documents for Remote Monitoring of Patient Data, Access of EHR, Data Cleaning and Statistical Analysis, and the Database Lock Risk Assessment (during the COVID-19 pandemic).

ROLE: CRO/Vendor Alliance Management

• Developed the governance structure and operating principles for the newly formed Innovative Medicines Development organization (ring-fenced non-oncology development team within BMS) with the new sole provider CRO.
• Developed the strategic plan for asset transitions, systems integration, governance, ways of working, contracting, due diligence, and change and communications.
• Developed framework for process development, documentation, and execution with the CRO preferred partner.
• Established the digital Partnership Handbook & authored partnership level and study level processes.
• Developed the KPIs and metrics that were used to track performance tied to annual bonus/penalty.
• Worked closely with R&D Learning to develop training on key processes; maintained training curriculum for all Innovative Medicines staff and monitored CRO Partner training compliance.
• Prepared team for regulatory inspection by ensuring training on partnership processes was provided and documented. Training was reviewed as part of an FDA Audit and no findings were reported.
• Coordinated vendor relationships to ensure compliance with operational standards and contractual agreements.

Provided leadership and oversight on a variety of life sciences projects.

• Developed the partnership framework, operating model and principles including the Partnership build PMO and US-Japan operating committees for 3 different Quintiles CRO/sponsor partnerships/alliances.
• For a top biotech company, executed Core/Non-core workshops to identify strategic areas to retain in-house and identified over 20 areas with CRO/Sponsor duplication of tasks, resulting in transformation of clinical development processes in more than 10 areas to reduce cycle times and elevate the partnership.
• For a device and diagnostic company essentially comprised of 7 separate business units, conducted an in-depth process analysis to identify cost savings & ran strategic prioritization session with executive leadership team.
• Reduced a Biotech’s study start-up timelines by 2 months by identifying and implementing process improvements in the areas of country and site selection, contracting, & clinical supply.
• Established and implemented a Process Owner Network for a top biotech.
• Developed methodology & managed the audit of a full eTMF for a marketed product that was being in-licensed.
• Developed and mentored consultants & prepared detailed end-of-year feedback for annual calibration process.
• Managed a team of Regulatory consultants executing a product marketing authorization holder transfer.
• Led a quick-turn market research assessment for a top pharma client exploring the commercial opportunity of a potential in-license product and delivered a recommendation on the commercial potential of the product.

• Analyzed client operations to identify areas for process improvement and cost reduction.