Provide clinical and scientific input into Discovery Research and Early Development activities, including disease education, target identification, lead selection, preclinical pharmacology POC, nonclinical toxicology, biomarker strategy and IND enabling studies, to develop optimal translational medicine approaches to facilitate development to clinical POC
The Medical Director is the lead clinical authority and supervisor within the management team and for all clinical services provided throughout the unit; director is responsible for the development and implementation of compassionate, cost-effective medical and psychiatric care within the unit.
The Director, GMA Project Manager, is responsible for senior client interaction, the execution and overall implementation of strategic, global, complex projects within the Global Medical Affairs organization.
This position is accountable for the timely delivery of high quality, regulatory-compliant documents spanning the clinical study process including protocols, IBs, study reports, health authority briefing books and clinical summary documents for submissions across the Alexion portfolio.
The Senior Director of Biocompatibility and Toxicology group in the Preclinical Center of Excellence (COE) will dead the toxicological and biocompatibility evaluation of products and technologies required for product approvals and patient safety across MD.
Directly supervise and schedule physicians, nurse practitioners, physician assistants, and psychiatric clinical nurse specialists according to Health Services needs while adhering to union contractual agreements.
Manage the writing and completion of documents and other assigned tasks within established timelines (editing and QC) and with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
Maintains navigational electronic database to document on- and off-label unsolicited requests for information from HCPs in accordance with Haemonetics internal guidelines and FDA guidance for industry.
The Technical Director is responsible for the Engineering department in a medical component manufacturing environment. Responsible for the successful planning, management and execution of assigned product development or process development projects as well as supporting maintenance of business requirements.
The Associate Medical Director (AMD) is responsible for driving the strategic development and implementation of the Medical Cost Management approach for Health Services and for providing clinical leadership for the assigned market.
In this role, you will Provide medical insight to the development of design specifications; medical expertise to regulatory submissions; participation in meetings with regulators (e.g. FDA); review of marketing and promotional materials.
Ensuring that all Sanofi Oncology PD-1 product data generated by the company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner.
The Medical Director will provide support for strategic planning and leadership in an identified therapeutic throughout the Americas (US, LATAM and Canada) region. Responsible for providing scientific and medical support with an in-depth understanding of the medical landscape.