The Sr. Scientist, will be based within the Translational Sciences department within the Applied Research organization working on the Pharmacokinetic evaluations of novel or reformulated chemical and biological entities compatible with the company’s drug delivery device technologies. This individual will be responsible for the development and execution of the pharmacokinetic and PK/PD studies supporting the overall development plan for the pharmaceutical combination projects.
The successful candidate will be expected to provide expertise in PK and PK/PD study design, protocol development and execution, data analysis, modeling, interpretation and reporting. Apply various approaches and strategies to predict human PK parameters from analysis of nonclinical data. Also assess PKPD properties of drug candidates based on preclinical data. Author clinical and nonclinical PK sections for regulatory submissions and clinical investigator brochures. He/She will work independently while also collaborating within the group and across functional groups, matrix teams.
Designs and conducts pharmacokinetic research for the advancement of NCEs and reformulations from discovery through development. Based on corporate strategic objectives, develops pharmacokinetic research plans that lead to the enhancement of the company's technology and intellectual property (i.e., concepts, patents, techniques, product registration). Conducts due diligence and feasibility assessments for business development activities.
Provide expertise within Translational Research and inter-departmentally to fulfill pharmacokinetic, pharmacodynamic, toxicodynamic, and local drug delivery initiatives. Designs and executes PK and PK/PD study protocols, analyses and models data and writes internal study reports and oversees and monitors PK study conduct and reporting at CROs.
Provides regular and open communication to keep project teams, and management informed of direction, progress and strategic developments in supporting and meeting of MB objectives. Actively participates in departmental committees/meetings as an advisor in scientific, administrative and regulatory areas. Recommends to management the purchase or modification of equipment, facility renovations, and allocation of resources to meet strategic pharmacokinetic and R&D objectives.
Writes expert opinions, reports and regulatory submissions to meet marketing registration needs for products. Stays fully informed of advancements in biologics research and development and regulatory positions to advise and adjust research direction to ensure products will meet objectives for regulatory and medical needs.
Acts as a representative for the company to outside parties and regulatory agencies for Glaukos products. Attends scientific meetings to acquire and share new ideas and to maintain state-of-the-art knowledge in field of specialization. Writes patents, scientific articles and makes presentations at national scientific meetings. Stays abreast of technological advancements through extensive reading of internal and external reports, scientific findings, professional journals, and regulatory positions.
• Broad understanding of pharmacokinetics and PKPD modeling strategies and hand’s on experience with PK and PK/PD modeling tools (i.e. Phoenix/Winonlin, NonMem)
• Experience in analyzing and reporting nonclinical PK study data and human PK from clinical trials
• Effective written and verbal communication skills; strong understanding of regulatory environment to support regulatory and corporate agencies.
• Experience in writing sections 2.4 and 2.6 of CTDs
• Strong scientific and leadership skills with the ability to be a subject matter expert at matrix teams and influence and collaborate. Ability to work within a diverse workforce.
• Active scientific participation and collaboration with colleagues in industry, academia and regulatory agencies.
Ph.D. with 4-6years of relevant industry experience.