James Dean
- Role
- Executive Medical Director and Global Development Lead, Imbruvica and Pediatrics (Oncology) at AbbVie
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About James Dean
Physician-Scientist (Medical Oncology, Biochemistry) with interests and experience in…
Experience
Executive Medical Director and Global Development Lead, Imbruvica and Pediatrics (Oncology)
Jul 2021 — Present
AbbVie One Oncology Executive Medical Director and Global Development Lead for IMBRUVICA and Pediatrics, with responsibilities across all IMBRUVICA activities from the clinical development perspective as well as pediatric development across oncology assets. Providing leadership in development of end to end clinical development strategies for select emerging pipeline assets through registration. Broad tactical and strategic responsibilities including ongoing programmatic initiatives, clinical and translational studies, and collaborative support for regulatory interactions, clinical, translational, and preclinical ISTs, and publications. Managing a team of up to ten direct reports, responsible for Imbruvica development activities and cross-functional team leadership, as well as pediatric development across oncology assets. Ongoing regulatory experiences in US, EU, UK, Australia and New Zealand, including author/review/edit of regulatory documents (NDA, sNDA, MAA (and Variations), briefing documents, PMR, PAM, RMP, PBRER, DSUR), face-to-face and teleconference FDA interactions. Author on numerous publications. Global Study PI, Steering Committee, Advisory Board, and KOL interactions. Business Development due diligence activities. Clinical, Translational and Scientific resource.
Skills
- Cell
- Life Sciences
- Medicine
- Biochemistry
- Therapeutics
- Immunology
- Drug Development
- Biotechnology
- Lifesciences
- Translational Medicine
- Oncology
- Molecular Biology
- Translational Research
- Chemistry
- Clinical
- Clinical Development
- In Vitro
- Biopharmaceuticals
- Research
- Clinical Research
- Pharmaceutical Industry
- U.s. Food and Drug Administration (Fda)
- Genetics
- Protocol
- Clinical Trials
- Cell Culture
- Cell Biology
- Medical Writing
- Biomarkers
- Infectious Diseases
- Cancer
- Cell Based Assays
- Internal Medicine
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