Ian Lauf

Charismatic, visionary global life sciences industry executive with 23+ years' overall experience & 15+ years' direct leadership experience in the pharmaceutical, biotechnology, & medical device sectors seeking a senior leadership position at a company in start-up, growth, or restructuring phase where my skills & experiences will help accelerate the organization's success developing new medicines & medical devices for patients in need of new treatment options. Resilient, entrepreneurial, business-minded strategic transformational leader known for building high-performing teams, creating results-driven performance cultures, navigating complex matrix organizations with large cross-functional teams, innate ability to connect with & relate to employees at all levels, exceptional coaching & mentoring skills, strong ability to influence, & exemplary employee recruitment & retention history. Career includes positions held in various alliance management, outsourcing, finance, & operations roles at start-up, small, mid-sized, & large companies with global operations & diverse multi-cultural teams. Extensive experience building, growing, globalizing, stabilizing, & restructuring departments & operations based on existing & future business needs, including multi-million dollar cost-savings. Demonstrated track record of delivering high-quality, measurable results with increasing levels of responsibility, workload volume, numbers of direct reports, overall size of teams, & autonomy in decision-making. Successful history directly managing & overseeing individual contracts valued up to $550M, total external yearly spend up to $760M, & total aggregate contracted liabilities exceeding $3.2B. Past & present member of senior & executive leadership teams. Open to relocation; in-office, hybrid, or remote work; & domestic & international travel. Pragmatic professional with solid experience in leadership roles. Adept at implementing strategic business plans, driving growth and improving operations. Skilled in financial management and stakeholder relations. Collaborative and dedicated to building and leading talented and motivated individuals. Top-notch [Job Title] with proven track record of success leading and growing organizations. Strong background in strategic planning, financial management and team development. Skilled in identifying opportunities and implementing practical business strategies with commitment to staying informed about latest trends, technologies and best practices. Persistent leader eager to lead and grow organizations. Skilled in strategic planning, problem-solving, and communication with good understanding of business principles, project management and team leadership. Collaborative with relentless work ethic.

• Recruited into senior leadership role by SVP, Development Operations via mutual industry connections to restructure R&D outsourcing department (people, processes, systems, & data flow) & prepare team for exponential growth due to success, evolution, & maturation of company.
• Recruited into newly created senior leadership role to manage & drive transition of company’s portfolio of new & ongoing clinical trials from complex hybrid insourced/outsourced global R&D model (300+ vendors) to full-service global R&D single source CRO partnership model with two supportive FSPs.
• Implemented resource tool for global R&D business unit to support strategic business planning, effectively manage employee workload/deliverables, & manage FTE/contingent employee headcount expansion/contraction needs.
• Founded management consultancy dedicated to providing strategic & tactical advisory services to global life sciences industry. Clients included pharma/biotech/medical device companies, CROs & other life sciences industry service providers, AROs, CMOs/CDMOs, CSOs, mutual funds, hedge funds, private equity firms, venture capital firms, investment banks, management consultancies, & law firms. Client engagements included but were not limited to analyzing data, creating make vs. buy decision matrixes, assisting with expansion & growth into new customer segments, vetting of potential new product offerings, developing sales & marketing plans, & proposing solutions to issues related to procurement, outsourcing, alliance management, finance, & operations within R&D, manufacturing, sales, & marketing, as well as providing strategies, tactics, & due diligence for M&A, licensing, divestitures, restructurings, capital raising, investments, & IPOs.
• Hand-picked by business unit president to be secretariat of global, company-wide, cross-subsidiary, cross-functional continuous improvement & compliance directive comprised of 35 unique projects & sponsored by global CEO & other executive leaders to reduce legal & compliance risks, streamline operations, eliminate redundancies, & reduce costs.
• Recruited & hired by ex-colleagues to rejoin former team/company & provide temporary leadership & SME during integration of departments, tools, templates, policies, & procedures necessitated by large-scale reverse merger.
• Grew department resources by > 100% (13 FTEs to 27 FTEs) in less than 24 months across existing local & newly established cross-country brick & mortar location while limiting employee turnover to one voluntary resignation in four years.
• Nominated 11 employees for promotions in four years & successfully defended approval of nine promotions (82% success rate).
• Grew US team from three to eight team members in 11 months & drove increased collaboration, transparency, & communication between department team members & cross-functional team members in US, Japan, & Europe.
• Developed company-wide rewards & recognition program for FTEs to increase morale, boost productivity, improve employee recruitment & retention, & promote a culture of teamwork, innovation, belonging, & focus on people.
• Managed project budgets & clinical business relationships with three external alliance partners (Takeda Pharmaceutical Company Limited [Japan], Duchesnay Inc., & Purdue Pharma L.P.) as core member of alliance steering committees.
• Managed global HIV vaccine clinical development strategic alliance with NIH & US HIV vaccine clinical development JV with Aventis Pasteur Inc.
• Reduced clinical development invoice review & approval timeline from average of 63 days to seven calendar days (88.9% reduction).
• Decreased HQs’ legal review timeline for vendor contracts from average of 15 days to < one business day (93.3% reduction).
• Reduced internal turnaround timeline for site budget/contract negotiation escalations from average of 47 days to four calendar days (91.5% reduction).
• Developed & implemented new global budget & contract process for outsourced R&D services that eliminated need for 75% of budget & contract amendments.
• Reduced global clinical development costs by 19% via completion of global clinical development cost-effectiveness analyses.
• Received President’s Award due to outstanding performance, diverse & inclusive approach to change management, measurable accomplishments, & exceptional leadership throughout duration of critical business transformation initiative (all-expenses-paid trip for two to Turks & Caicos).
• Recognized by manager, in writing, in performance evaluation for “turning performance of US clinical outsourcing team around in less than five months’ time.”
• Presented Individual Performance Award for exceptional performance & leadership demonstrated on Oncology Business Unit outsourcing strategies & initiatives project.
• Nominated for & selected to participate in International Management Development Program.
• Received one Golden Achievements Program Champion Standing Ovation Award, nine Manager-to-Employee Awards, & one Peer-to-Peer Award for superior customer service, leadership, & teamwork skills & consistent high quality of project deliverables.
• Awarded two Director’s Awards for remarkable accomplishments & teamwork during quarterly budget review.
• Selected to participate in Merck Mentoring Program.
• Promoted from Associate Director, Clinical Alliance Management to US Department Head, Global Clinical Outsourcing & Global Department Head, Clinical Alliance Management after four months in position.
• Promoted from Assistant to Associate Medical Program Financial Specialist after six months in position due to exemplary performance & measurable accomplishments.

• Alliance Management
• Business Development/Licensing
• Clinical Development
• Clinical Operations
• Compliance
• Data Management
• Drug Discovery
• Drug Safety/Pharmacovigilance
• Finance/Accounting
• Human Resources
• Information Technology/Digital Transformation
• Legal
• Manufacturing/Supply Chain
• Marketing
• Medical Affairs
• Medical Writing
• Preclinical/Nonclinical Development
• Program Management/Project Management
• Public Affairs
• Quality Assurance
• Regulatory Affairs
• Sales
• Statistics/Statistical Programming
• Technical Operations

• Cardiology/Cardiovascular
• Infectious Diseases
• Liver Diseases
• Metabolic Diseases/Endocrinology
• Neuroscience/Pain
• Oncology/Hematology
• Pediatrics
• Rare/Orphan Diseases
• RX-to-OTC Switch
• Vaccines
• Women’s Health

• Biosimilars
• Generics
• Large Molecules/Biologics
• Small Molecules/Chemically Synthesized Molecules

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• I
• II
• III
• IV

• Clinical Data Management Innovation: Presentation: CRO Outsourcing Trends
• Clinical Trial Budgeting & Project Management: Presentation: Examine the Financial Relationship Between Site, Sponsor, & CRO
• Clinical Trial Budgeting & Project Management: Presentation: Streamline the Contract & Negotiation Process to Avoid Study Delays
• Contract Pharma: Publication: Evolving Tactical Relationships into Global Partnerships: Sponsor-CRO Relationships in Transition
• Cost & Contract Management for Clinical Trials: Presentation: Achieving Compliance by Reconfiguring Payment & Contracting Strategies in Light of Fair Market Value
• Cost & Contract Management for Clinical Trials: Presentation: Gauging the Downstream Impact of Consolidation & Turbulent Economic Conditions on Sourcing Agreements
• Partnerships in Clinical Trials: Presentation: Clinical Trial Outsourcing Dollars & Financial Sense
• Partnerships in Clinical Trials: Presentation: Disruptive Drug Development – The Clinical Leadership & R&D Forum
• Partnerships in Clinical Trials: Presentation: Evolving Tactical Relationships into Global Partnerships: Sponsor-CRO Relationships in Transition
• Partnerships in Clinical Trials: Presentation: Wall Street & Private Equity Perspectives – Economic Outlook on Investment Areas, Growth Opportunities, & the Outsourcing Industry
• R&D Open Innovation & Portfolio Optimization: Meeting Chair
• R&D Open Innovation & Portfolio Optimization: Presentation: Improve the Outsourcing Model – Improve Efficiencies & Accelerate Cycle Times
• Sponsor/CRO Systems & Business Process Integration: Meeting Chair
• Sponsor/CRO Systems & Business Process Integration: Presentation: Benchmarks & Best Practices for Sites, Sponsors, & CROs to Achieve Study Milestones & Objectives
• Sponsor/CRO Systems & Business Process Integration: Presentation: Best Practices to Ensure Effective Collaboration & Partnership Management in Global Studies

• Advisory Board Member: Clinical Trials Congress
• Advisory Board Member: Partnerships in Clinical Trials
• Advisory Board Member: PRA Health Sciences
• Association of Strategic Alliance Professionals (ASAP)
• Drug Information Association (DIA)
• Institute of Management Accountants (IMA)
• International Association of Outsourcing Professionals (IAOP)
• Linking Leaders – The Clinical Outsourcing Roundtable Network
• Model Agreements & Guidelines International (MAGI)
• Peer Review Board Member: Partnerships in Clinical Trials