Lee Anne McLean

About Lee Anne McLean

Senior biomedical scientist with 23 years in the pharmaceutical industry, both in the clinical and preclinical setting. Experience with clinical and scientific aspects of clinical trial start-up and execution, safety monitoring, data analytics and cross-functional collaboration. Excellent analytical, verbal, and written communication skills, with extensive experience in analysis and presentation of complex data, writing and editing clinical and preclinical documents (clinical protocols, informed consents, Investigator Brochures, regulatory documents, investigative toxicology reports, external publications, etc.). Understanding of FDA, ICH, GLP, GCP and other regulatory guidelines related to clinical trials, drug safety, toxicology, and biomarkers.Key expertise in: • Clinical Trials • Medical Monitoring • Biomarkers • Data Analysis • Scientific Writing • Drug Safety / Toxicology

Experience

1. Senior Director, Asset Lead Early Oncology, Clinical Science, at Daiichi Sankyo, Inc

   Daiichi Sankyo US

   Jul 2022 — Present · Basking Ridge, NJ, US

   Serving as Clinical Science Asset Lead for multiple antibody-drug conjugate (ADC) and/or immuno-oncology (IO) compounds in early phases of oncology clinical development- Manage group of up to 16 clinical scientists from Manager to Director level, including hiring, onboarding, training, mentoring and performance review- Attend study level global project team (GPT) and clinical strategy team (CST) meetings for early assets to provide strategic and scientific input when necessary and attend various governance meetings as needed in support of study-level clinical scientists- Review and contribute to study-level documents such as protocols, amendments, informed consent forms (ICFs), governance slide decks/memos as required- Represent Clinical Science in several cross-functional initiatives, including integrated data review process (IDRP), protocol/protocol profile template updates, ICF process (including templates, SOP, and eConsent – as business leader), in-house medical monitoring and data standards updates- Provide trainings to Clinical Science and Clinical Development on data review processes in conjunction with Data Management, including adverse event and laboratory data review, using both personally developed Excel trackers and new/upcoming JReview reports and dashboards.

Education

• Johns Hopkins Bloomberg School of Public Health

  MHS, Environmental Health Engineering

  1988 — 1989

• University of California, Davis

  PhD, Physiology

  1993 — 1999

• Rensselaer Polytechnic Institute

  BS, Biomedical Engineering

  1982 — 1986

Skills

• Medical Writing
• Technical Presentations
• Oncology
• Cell
• Data Analysis
• Pharmacogenomics
• Life Sciences
• Pharmacogenetics
• Molecular Biology
• Biomarkers
• Pharmaceutical Industry
• Drug Safety
• Genomics
• Clinical Trials
• Cell Culture
• Genetics
• Toxicology
• Drug Development
• Clinical Development
• Western Blotting
• Drug Discovery
• Assay Development