Adjunct instructor of management strategy and cell & gene therapy

Our mission is to improve human health and performance by creating clinically-proven, non-invasive neurostimulation products.

Targeted Protein Degradation

Led the Supply Chain, Quality Assurance, and Program and Portfolio Management functions. • Implemented supply chains for a regional CMO network supporting global ex vivo autologous gene therapy clinical trials. • Built the Quality Assurance organization and implementation roadmap for a comprehensive, phase-appropriate Quality Management System.

Management consultant and advisor for strategy and business operations, including developing a growth strategy for a rapidly expanding boutique research firm (CRO) and operational effectiveness for a medical device company’s US business.

Led the global delivery of commercial and clinical supply for the oncology portfolio (>$5B revenue, ~20 pipeline programs). Managed global teams based in the US, UK, and Sweden with responsibility for supply chain strategy, design and optimization, new product launch planning, inventory management, service delivery, incorporation of third-party providers, business continuity planning, and risk management. • Delivered ~80 market launches of five brands, on time every time.• Executed three new product launches in the US within 24 hours of approval (Imfinzi®, Lynparza®, and Calquence®). Launched Tagrisso® in China in 23 days, one third of the typical timeframe.• Exceeded supply service level targets, achieving 99.6% stock availability of 11 brands across >80 markets globally (vs. target of 99%).• Ensured flawless supply of Lynparza® during rolling market launches and multiple, simultaneous supply chain changes (capsule to tablet formulation, qualification of 2nd source for API, parallel formulation site tech transfers, limited capsule recall, and cold chain implementation).• In collaboration with manufacturing, engineering, technical development, and finance colleagues, developed $200M Board proposal for new Zoladex® formulation plant.

Directed a global organization of 140 staff and 600 contractors across five sites in the US, UK, Sweden, and India ($180M budget). Managed core business operations essential to all functions and sites. Oversaw project and portfolio management, facilities management, scientific services, lab operations, strategic planning, capital budgeting, compliance, and scientific communications. Secretariat for the AstraZeneca Board Science Committee. • Built a global Project Management organization to enhance planning, execution, and tracking capabilities for the portfolio of IMED drug development projects. From 2013 to 2016, key R&D productivity metrics improved and exceeded industry benchmarks (probability of success increased while cost per candidate drug, cost per phase of clinical development, and clinical study cycle times all decreased).• Reduced overall site facilities costs by $71M (33%) 2013-2016 while increasing both vibrancy and service levels. Transformed an underutilized research site in Boston by developing and implementing a “BioHub” model. Operating expenses were reduced by $16M (47%) while collaboration increased; more researchers were on site than at any point in the facility’s history.• Achieved the highest overall scores of any IMED function in AstraZeneca’s biennial climate survey, reflecting high levels of staff motivation, engagement, and belief in organizational strategy and direction.• Planned and facilitated biannual meetings of the Board Science Committee to assess the quality, competitiveness, and integrity of R&D activities. Organized multiple ad hoc Science Committee meetings to review specific acquisition and business development proposals.

Aligned company strategy, time and focus of the President, and the activities of MedImmune’s executive team to orchestrate an agenda for leadership across the organization. Oversaw business governance forums and preparation for key external engagements with trade organizations and government. Led MedImmune’s annual planning process. • Every financial target and enterprise scorecard objective was met or exceeded. • Key industry alliances were established and executed (co-development of five molecules with Amgen, manufacturing capacity sharing with Merck, and China JV with WuXi).

Selected by SVP of Quality to build and lead organization of 20 risk management professionals across a global manufacturing and distribution network. Led major operational excellence initiative to analyze and mitigate risks to product supply.• Developed and implemented mitigation strategies for key risks from geographic concentration of operations, single sources of raw materials and manufacturing, and distressed suppliers.• Established a business continuity plan for North American distribution operations, providing risk mitigation of $11.5 billion annual revenues.

Expatriate assignment reporting to the SVP, International Chief Medical Officer. Integral to all operational aspects of building then managing an integrated multinational organization of 900 medical and clinical research staff in 27 countries ($320M operating expenses). Planned and executed multiple strategic initiatives, including the subsequent reorganization of 220 staff and $100M operating expenses into R&D.• Led cross-functional analysis of the size, structure, and business processes of regional headquarter and country affiliate organizations. Developed and implemented restructuring plans that reduced cumulative operating expenses by $85M which funded the expansion of Eastern European operations.• Developed resource deployment plans for market expansion and product launches in new therapeutic areas.

Drove the development and implementation of a global strategic plan for the largest oncology program in Amgen’s pipeline ($400M budget, 8,000 patients, six Phase III, and five Phase II studies across indications). Orchestrated execution of product development strategy across clinical development, commercial, operations, regulatory, medical affairs, and health economics.

Built and led a 14-person organization to manage business development operations and external research alliances.

Co-led team in the design and execution of an erythropoiesis-stimulating agents (ESA) medical usage evaluation involving 1,000 patients from approximately 30 sites and sources. Drove preparation of multiple submissions to the Center for Medicare and Medicaid Services (CMS) analyzing dosing and outcomes of Aranesp® and Procrit® patients. Senior project manager for NEUPOGEN®/Neulasta® Operations, Medical Affairs, and Clinical Development functional teams. Planned and executed a Neulasta® manufacturing technology transfer with a partner company.

Selected by SVP, HR to lead cross-functional team developing and executing a comprehensive plan for staff selection and integration during $13B acquisition of Immunex. Utilized Six Sigma methodology, led a staffing process improvement project resulting in annualized savings of $5-10M. Program Manager for leadership development and talent management programs.

• Ranked in the top 10% of faculty by student surveys.• Assistant Coach and Operations Officer for varsity offshore sailing team

Commanding officer of a special operations ship with a crew of 30 for numerous counter-narcotics, Navy SEAL, and Army Special Forces missions. The most junior Surface Warfare commanding officer in the US Navy during this assignment. • Seized ~$25M worth of controlled substances during bilateral mission with the Colombian Navy. • Earned Navy Battle Efficiency and Golden Trident unit awards for outstanding material condition, training proficiency, combat readiness, and working environment for crew.

Led a division of 40 engineers accountable for the operation, maintenance and repair of propulsion and auxiliary engineering systems. • Overall coordinator for Operational Propulsion Plant Examination (OPPE), a comprehensive engineering inspection required to certify ship for operations. Completed the 3-day inspection in 36 hours (a Pacific Fleet record for that year) with 75% fewer discrepancies than fleet average.• Project manager for over 50 complex ship alterations during 14 month, $100 million overhaul.