Iman Jilani Email & Phone Number

Wisconsin, United States/San Diego

• Direct and oversee Translational Biomarkers activities to ensure achievement of department objectives; proactively collaborate with discovery and clinical teams to align efforts with program needs• Develop and execute the strategy for operating objectives, organizational structure, staffing requirements, space and instrumentation• Oversees in-house infrastructure, systems and procedures to ensure fit for purpose laboratory practices for analytical methods and testing in clinical study… Show more • Direct and oversee Translational Biomarkers activities to ensure achievement of department objectives; proactively collaborate with discovery and clinical teams to align efforts with program needs• Develop and execute the strategy for operating objectives, organizational structure, staffing requirements, space and instrumentation• Oversees in-house infrastructure, systems and procedures to ensure fit for purpose laboratory practices for analytical methods and testing in clinical study samples• Implement and maintain efficient processes and procedures to provide high quality standards and study design, study execution and timely reporting• Maintain up-to-date knowledge of current industry practices• Monitor performance of direct reports and ensure that management training and development needs are addressed Show less

San Diego, California, United States

Are you in need of a highly accomplished and experienced professional to lead your clinical trial implementation, biomarker, and diagnostics projects? With over 30 years of expertise in these areas, I offer unparalleled leadership and a proven track record in people management, regulatory compliance, and operational processes.Expertise Highlights:•Biomarker and Diagnostics Clinical Trial Implementation: 1. Specializing in scientific, technical, and operational aspects… Show more Are you in need of a highly accomplished and experienced professional to lead your clinical trial implementation, biomarker, and diagnostics projects? With over 30 years of expertise in these areas, I offer unparalleled leadership and a proven track record in people management, regulatory compliance, and operational processes.Expertise Highlights:•Biomarker and Diagnostics Clinical Trial Implementation: 1. Specializing in scientific, technical, and operational aspects 2. Proficient in various platforms, including but not limited to cell-based assays, IHC, Flow Cytometry, CTC, PCR, and NGS•Leadership Roles: 1. Group Leader and Head of Oncology Biomarker Clinical Assay Group 2. Responsibilities include CRO vendor management, alliance management, quality management systems, clinical trial/data management, Trial Master File management, and regulatory submissions.•Regulatory Compliance: 1. Extensive knowledge of GCP, GCLP, GLP, CLIA, ISO, ICH, and CAP standards 2. Experience with regulatory submissions and quality management systems•Publications and Leadership: 1. Over 45 peer-reviewed publications 2. Active involvement in leadership teams, oncology biomarker subspecialty teams, and national meetings•Vendor and CRO Oversight: 1. Proven history of cost savings and successful contract negotiations 2. Development of best practices and operational improvements 3. Alliance partnerships and academic research collaborations•Comprehensive Clinical Trial Support: 1. Expertise in oncology, rare diseases, gene therapy, and inflammation trials 2. Strong scientific, technical, and managerial skillsAs an independent consultant, I am dedicated to bringing my multifaceted skills to your organization, ensuring the success of your clinical trials and biomarker initiatives. Let’s connect to discuss how I can support your team. Show less

La Jolla, Ca

Group Leader and Head Scientific/Operations and Clinical Trial Biomarker expert Leader–Global Pharma and Biotech with over 30 years of experience with a unique blend of scientific/technical biomarker platform expertise, CRO Vendor management/engagement skills, Quality management system, Quality Assurance, Clinical Trial/Data Management, alliance relationships/partnerships, regulatory submissions (FDA, HGRAC, EMA or NMPA) and compliance (ICH, CLIA, CAP, GxP, GDPR, HIPPA etc.).