Ryan Lindeman Email & Phone Number

Indianapolis, Indiana, Us

Clinical trial design and clinical program design enabling accelerated development and delivery - reducing risk, optimizing value, and decreasing time to submission.Leader of transformational initiative to develop world-class clinical design capabilities to apply across all therapeutic areas.Develop and support direct reports in their career within the function and drug development.Programs including Alzheimer's, Psychiatry, Parkinson's, Multiple Sclerosis (MS), ALS, etc.

Indianapolis, Indiana, Us

Design and develop clinical trials and programs to accelerate molecules through Phase II, Phase, III, Registration, and Post-launch. Proven ability to create strategies that reduce cycle time of blockbuster molecules to launch by over 6 months and reduce R&D program spend by millions of dollars. Establish clinical development platform and foundation for novel gene therapy agents meeting targeted needs of patient population, delivery platform, regulatory expectations, and commercial and medical environment.Continued corporate leadership from previous role for Decentralized Clinical Trial design and establishment.

Indianapolis, Indiana, Us

Design and manage clinical programs and trials to deliver data leading to regulatory and PRA submissions. Employed novel clinical designs and operational approaches to execute the Covid antibody platform to respond to world-wide pandemic needs. Recruited to lead program management and corporate implementation for Decentralized Clinical Trials - capabilities, program infrastructure, strategy, exection, and organizational implementation and change.

Indianapolis, Indiana, Us

Accountable for strategy and execution of drug development, new product planning, clinical design and operations, and line extensions for the Immunology and Pain platforms by integrating International regions (Europe, China, Japan, Emerging Markets) with the US.Integrated drug and clinical development business processes (e.g. design fundamentals, governance, etc) across regions and connecting the needs from Europe to Asia Pacific to Latin America. Translate regulatory, product access / PRA, marketing, medical, clinical, and manufacturing requirements and constraints into plans that maximize value to patients, prescribers, and shareholders. Continuously optimize the strategy through cross-functional global team leadership and by capitalizing on opportunities within the changing environment. Develop plans with budgets up to $200 million enabling annual revenue over $500 million.Additionally requested by senior leadership to develop and lead organization change initiatives, strategic assignments, and support business development within the Eli Lilly corporation, Research and Development function, and/or the broader Project Management community.

Indianapolis, Indiana, Us

Advise and lead the China Drug Development organization across all therapeutic areas (Immunology, Diabetes, Oncology), specifically within Project Management and Clinical Operations, to improve processes and enhance capability within a fast-changing environment. Liaison with global stakeholders and team members to improve regional integration within the corporation.Accountable asset plans resulted in the successful approval of a new product months ahead of plan despite a significant change in regulatory strategy.Provided individual, peer, and program mentoring and coaching that influenced people and leadership performance and development.

Indianapolis, Indiana, Us

Proactively develop the clinical program strategy and execution for next generation pharmaceutical products and indications with immunology / autoimmune. Design and manage clinical scope with budgets over $150 million - with successful execution on time, in full, under budget, and with successful regulatory approval. Leverage learnings and balance resources and priorities across programs globally, centrally, and in the field / sites to deliver the program scope. Additionally, assigned as the primary contact and program lead for several projects outsourced to strategic partners. Thus, provide leadership during contract development, negotiation, and delivery of key milestones.

Indianapolis, Indiana, Us

Maximize the value of multiple, marketed, assets by developing, managing, and delivering an integrated program and portfolio of projects across the manufacturing value chain: Raw Materials, API and Drug Product Operations, Regulatory Reporting, Quality Assurance, Packaging, Supply Chain, and Distribution. Establish relationships and partnerships horizontally and vertically (within the business unit, marketing, operations, and commercialization) to understand internal needs and external customer needs and to set an action plan to modify the asset to meet those needs (margins, features, improvements, right-to-operate, etc).Leveraged to provide expertise and input to due diligence evaluation of potential external partners or suppliers.

Indianapolis, Indiana, Us

Utilize continuous improvement methodology to implement Lean Six Sigma process improvements across all aspects and functions of the business to deliver bottom line results. Refined the infrastructure needed to support a multi-site, global function of 160+ executives, engineers, and scientists in the areas of bulk API, Parenteral, Dry Products, and other Drug Product applications. Use leadership and project management to generate breakthrough solutions often times needing total engagement and cultural and organizational change. Serve as a leader, trainer, and mentor for lean program development and implementation within the organization.

Indianapolis, Indiana, Us

Individual accountability and direct report responsibility (between 4 and 11 direct reports) for day-to-day support and troubleshooting of pharmaceutical and regulated operations. Validation, qualification, regulatory compliance, reporting, and documentation. Project management for improvement projects by developing, executing, and evaluating data generated from laboratory, pilot, or production trials and experiments. Molecular asset ownership providing oversight from raw material supplier to delivery of finished product to the customer. Additional responsibilities with respect to change control, review boards, and process safety management leadership.

Midland, Michigan, Us

Lead design engineer on local and national capital and expense projects up to $12 million dollars across various technologies (plastics, polymers, and pharmaceutical). Directed work teams of engineers toward the completion of equipment design, monitored progress, and provided cost and schedule estimates. Six Sigma trained and involved with project development, execution, and program implementation. Process safety and EH&S evaluation of processes.

Louisville, Kentucky, Us

Supported design efforts for heat recovery steam boilers for the energy industry. Initiated and developed a time-saving design program to help communicate expected boiler performance to the customer. (Part-time position while completing MBA)

Masters, Business Administration (Mba)

Masters, Chemical Engineering

Bachelors, Chemical Engineering