Jobs in All Categories (26) Healthcare (4) Human Resources & Legal (4) Marketing, Media & Design (1) Operations & General Management (2) Project Management (1) Science & Education (12) Technology (2)
Participate in cross-functional project team meetings, provide feedback on experimental work completed and help determine strategies for accomplishing relevant goals
Enable communication of quantitative modeling results across cross-functional teams of clinicians, scientists and business development
Plan and manage inventory of commercial products, PEGPH20 bulk, PH20 bulk and ENHANZE Drug Product (EDP) for ENHANZE partners and products in development.
Lead key innovation and process improvement initiatives to help build internal capabilities and efficiencies with process and systems.
Monitor enrollment, track clinical data, regulatory documents, patient enrollment, and data resolutions to assist the timely completion of clinical studies.
Provide review and oversight on quality database design, validation, and deployment to ensure quality and efficiencies through data and process standardization.
Partner with IT to continually refine and update computer system validation and change control processes.
Support and collaborate with business partners around safety data evaluations and safety data exchanges, including the creation of safety data exchange agreements, review of safety materials received from our partners.
Responsible for the oversight of CROs, Contract Laboratories, IRT and other ancillary vendors associated with the conduct of a study
Exemplify a solutions oriented culture of teamwork, accountability, strong performance and excellence in competency and character.
Organize, analyze, and interpret data and prepare nonclinical study reports and summaries in appropriate corporate format.
Provide the high quality review and interpretation of study outcomes for assigned studies and oversees the presentation thereof in clinical study reports, related study documentation, and to varied team and governance audiences.
Develop preclinical models, in vivo non-invasive imaging, processing samples, data analysis, assisting with technical reports as well as validating new protocols.
Create and maintain regulatory timelines and track deliverables to timelines to ensure that internal and partner regulatory submission timelines are met.
Lead the management of regulatory activities for key projects and coordination of filing efforts between corporate disciplines.
Working closely with CROs, ensure agreed upon study timeline is meet with good quality of deliverables; validate CRO deliverables when needed.
Support the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages.
Assist in the transfer and performance of manufacturing techniques and the development and specification of processing parameters.
Coordinate and monitor transfers of critical reagents and documentation between Halozyme and outsourced labs.
Support Translational Medicine and Patient Reported Outcome work for the study (companion diagnostic development and PRO assessments for the study).
Manage the work, timeline deliverables, and relationship with PK/PD CROs, consultants and collaborators.
Utilize journal articles and other scientific resources to design and implement experimental methods.
Perform complex financial and market modeling in Microsoft Excel or Access, creating presentation ready slides and graphs to support strategy and business development decisions.
Independently research, prepare, and present on global regulatory topics to internal and external stakeholders.
Develop health and safety policies and procedures (chemical safety, ergonomics, illness and injury prevention and building safety), including those pertaining to hazardous materials and work areas.