Jobs in All Categories (19) Healthcare (3) Marketing, Media & Design (2) Operations & General Management (1) Project Management (1) Sales & Business Development (1) Science & Education (11)
Plan for and manage suppliers and vendors of reagents / materials required to produce company's products. Manage logistics and distribution of materials and products.
Lead key innovation and process improvement initiatives to help build internal capabilities and efficiencies with process and systems.
Participate in the selection and management of CROs and 3rd party vendors, which may include, but not limited to, contract monitors and analytical laboratories.
Create and maintain regulatory timelines and track deliverables to timelines to ensure that internal and partner regulatory submission timelines are met.
Lead interactions between company and outside vendors ( e.g. clinical local or central laboratories ) on the collection, transmittal and transfer of study specific vendor data.
Manage communications with and provide oversight to partner companies, collaborative sponsors & respective CROs regarding the evaluation & processing of case reports.
Develop and implement new PM processes, systems, and tools as needed to improve the functioning of program teams and project planning and status reporting capabilities.
The candidate will be responsible for independent Pharmacokinetic / Pharmacodynamic data analyses from nonclinical, clinical and toxicology studies including non - compartmental analyses, modeling and statistical evaluations.
Plan, design, and conduct nonclinical exploratory and drug delivery studies to evaluate SC drug delivery using the ENHANZE platform.
Support the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages.
Work with safety group with regards to providing integrated pharmacovigilance for the study. Work with multidisciplinary team on data cleaning and database lock activities.
Direct the work of junior level pharmacokineticists and pharmacometricians as appropriate.
Generate and leverage a range of marketplace insights to identify market-driving strategies.
Provide supportive for the scientific conduct of protocols and assist the study Medical Director with the scientific conduct of clinical studies for a single trial or across multiple phase I-III clinical trials.
Generate and leverage a range of marketplace insights to craft and deliver market making promotional messages and materials inclusive of personal and non-personal materials.
Partner with CFO to assess the LRP and the impact of recommended/identified strategic business development opportunities and options.
Work with clinical operations and data management in database review, query and clean-up activities in real-time and prior to database lock.