Novartis Biologics Unit is Novartis’ dedicated biologics discovery and development organization. Over the past several years, Novartis has had the greatest number of new molecular entities approved by the FDA for clinical use in the US. Novartis is expanding its biologics capabilities to leverage its deep disease area expertise and innovative internal research, as well as discoveries made at leading academic institutions and biotechnology companies.
Novartis has established the NBU to accelerate the advancement of its rich biologics pipeline. This startup unit is seeking entrepreneurial leaders and top scientists and technicians at all levels to build a development organization dedicated to delivering therapies that improve the lives of patients.
Responsibilities
1. To proactively manage links with other line functions to ensure that preclinical and clinical PK/PD information are used optimally for added value and integrated into biologics development plans
1. Serve as a key contact person for all PK related issues (preclinical and clinical PK) pertinent to the assigned project.
2. Responsible for the PK, PK/PD and M&S component of study protocols, reports, project summaries and development plans within agreed timeframes and which meet regulatory requirements.
3. Prepares appropriate responses to health authority (HA) enquiries (Globally) with specific references to the TA related PK issues in a timely fashion.
4. Interprets and presents project related study results and recommendations to the International Project Teams (IPT), NBU and ED management and Health Authorities worldwide.
5. Takes the lead on appropriate pharmacokinetic and biopharmaceutic studies
6. Takes lead in NBU Preclinical Sciences and Safety and ED sub-teams and works closely with physicians and scientists for successful completion of studies
The ideal candidate will have the following skills and experience:
Masters with 2-4 years or PhD level scientist with biological background with at least 2 years experience in biologics drug development or a relevant environment (e.g. Clinical Pharmacology, DMPK).
In depth knowledge of PK and PK/PD evaluation techniques required for protein-based molecules.
Experience of working in a team environment a plus.
Knowledge of regulatory requirements and experience in dealing with health authorities either through written summaries or oral presentations is desired.
The individual must be very effective at technical and scientific problem solving in a project driven, multi-disciplinary international environment, able to focus and work on several projects simultaneously and must possess excellent interpersonal, leadership and teamwork skills with very good organizational skills (e.g. planning and time management).
Must be fluent in written and spoken English.