The Senior Principal Scientist ( equivalent to Director ) of DMPK is accountable for timely and effective DMPK support for programs in preclinical and clinical development and for marketed products support.
Ideal candidates will have a deep knowledge of the hospital / institution / health systems structure and extensive experience in the oncology sales and account development as well as a robust understanding of the local dynamics that influence business in their area.
Work with Biologics, Small Molecule, and Pharmacology heads to design and execute pharmacology research studies that generate proof - of - concept data for novel biologic therapeutics and technology platforms.
Responsible for the management of clinical supply planning for assigned studies and programs. Leverages multiple data points to generate and refresh forecast including statistical models for studies and programs.
The Principal Scientist, Computational Biology will be a vital member of the growing Cancer Computational Biology group supporting Translational Research & Development programs, and providing experienced organizational, technological and scientific leadership.
Develop appropriate metrics for the assessment of the MSL function ( deliverables, performance, educational needs, staffing ). Present data at major meetings, such as managed care formulary meetings, Advisory Boards, etc.
Ensure appropriate allocation of resources across the company brands and pipeline, in line with Brand, corporate strategies and priorities; lead Medical Affairs team, including training and development of staff.
Provides medical review and interpretation of data, reviews draft reports and publications, searches and analyzes medical/scientific information; assists in or designs, authors and/or reviews clinical study synopses, protocols, amendments, study reports and other study-related documents.
Monitor and manage all costs associated with commercial packaging operations, and assess opportunities for improvement on an ongoing basis; assist with projects relative to commercial product packaging process improvements, scale-ups, and similar development activities at CMOs.
Lead a broad range of medical affairs activities, including: leading the medical review on Investigator Sponsored Trials, developing and executing the phase IV program, leading the publication strategy and ensuring the appropriate implementation of the publication plan in liaison with the publication lead, providing internal training, and conducting advisory boards.