Jaime A. Yáñez, Ph.D., Mba(C) Email & Phone Number

Waltham, Ma, Us

Rockville, Maryland, Us

• Director of Clinical Pharmacology that supports the development of global oncology programs.• Independently lead clinical pharmacology and modeling and simulation (M&S) activities to support oncology programs at varies regulatory milestones. • Provide quantitative pharmacology skills with experience in oncology development and implementation of Clinical Pharmacology strategy to support early- and late-stage development milestones. (PK/PD, exposure-response, model-based meta-analysis, etc).• Provide Clinical Pharmacology expertise and leadership in preclinical/clinical global development programs.• Develop program-specific, fit-for-purpose Clinical Pharmacology strategies, implement and execute the plans.• Ensure strategic alignment between functions, Clinical Pharmacology and senior leadership.• Provide hand-on quantitative PK/PKPD and M&S support, interpret and communicate findings effectively among operational or strategic teams. • Evaluate in/out-licensing opportunities of clinical PK and PK/PD components when needed.

Lima, Lima, Pe

Summary of Job: Professor (Part-Time) in the Doctoral (Ph.D.) Program in NutritionCourses: • Functional Antioxidants and Food Additives

Lima, Pe

Summary of Job: Professor (Part-Time) affiliated with the Career in Education and Learning Management.

• Consult about public health related issues.• Create educational and research material as videos and live transmissions.• Write research position papers.

• Led the R&D, Regulatory Affairs and Quality Assurance departments.• 62 product launches, and 108 product filings in Peru, Ecuador, Colombia, Bolivia, Chile, Argentina, Costa Rica, Mexico and United States.

Chorrillos, Lima, Pe

Summary of Job: Professor (Part-Time) affiliated with the Faculty of Human Medicine.Courses taught: • Thesis I

Lima, Lima, Pe

Summary of Job: Research Professor affiliated with the Vice-Rectorate of Research. Assigned to produce at least 9 original research papers indexed in Scopus.Professor affiliated with the Masters (M.Sc.) Program in Health ManagementCourses: • Thesis I and Applied Statistics• Thesis II and Biostatistics• Thesis III

Laval, Quebec, Ca

• Clinical Pharmacology program lead that supports development project teams across diverse therapeutic areas that contain small molecule and protein therapeutics contributing to the project strategies.• Provide scientific leadership on clinical pharmacology to support R&D and corporate strategy.• Supervise, develop, and mentor junior level scientists.• Develop and implement new clinical pharmacology tools and technologies to drive smarter drug development for programs.• Develop and maintain collaborative working relationship with colleagues within and outside the department.• Design, execute, analyze, and present related data to internal project teams and senior management.• Develop clinical pharmacology plans, timelines, and priorities to meet regulatory requirements across Phase1 – 3 studies, Phase 4, or post marketing studies as well as bioequivalence studies: ensuring proper design and flawless execution of dedicated clinical pharmacology studies where applicable• Oversee and ensure the proper conduct of PK and PK/PD analyses, and guide PK/PD modeling and simulation work as needed to for various drug discovery and development programs.• Develop model-based justifications for optimal doses selected for clinical studies including pediatric dosing justification• Provide effective communication with cross-functional groups, working closely with clinical study team and due diligence teams• Author/review/approve relevant sections of clinical protocols, analysis plans, study reports and regulatory submissions.• Maintain a high standard for good clinical practice, compliance, and ethics.• Maintain and establish relationships and agreements with contract vendors.

Lima, Lima, Pe

• Successful transition between management changes and expansion.• Reduced the operating budget by 18% and manufacturing losses by 3%.• Increased the manufacturing capacity by 12%.

Ingelheim Am Rhein, Rhineland-Palatinate, De

• Drug Metabolism and Pharmacokinetics, and Regulatory Affairs expert.• 22 fillings with FDA, EMA, Canada and Japan, and 72 GLP studies.

Geneva, Switzerland, Ch

• 14 fillings with FDA, EMA, Canada and Japan.• Modeling representative using WinNonlin, NONMEM and GastroPlus.

• 81 pre-clinical studies.• Main user of GastroPlus, DDDPlus and ADMET Predictor.

Master Of Business Administration - Mba, Health/Health Care Administration/Management

Certificate Program, Foundations Of Clinical Research

Diploma, Quality Assurance And Food Safety

Certificate, Auditor Of Integrated Food Safety And Quality Management Systems Based On Fssc 22000 And Iso 9001

Course, Specialized Program In Patents

Certificate, Medicinal Usee Of Cannabis

Course, Finance For Non-Specialists

Certificate, Management Of Scientific Projects

Ph.D., Pharmacology And Toxicology, Pharmacokinetics Emphasis

B.S., Food Science