How will you make an impact?
The Principal Scientist, ADME-PK, located in San Clemente, CA will work in Translational Sciences within the Applied Research department 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. He/she will apply various approaches and strategies to predict human PK parameters from analysis of nonclinical data and assess PK/PD properties of drug candidates based on preclinical data. He/she will author clinical and nonclinical PK sections for regulatory submissions and clinical investigator brochures. He/She will work independently while also collaborating within the Translational Sciences group and across functional groups, matrix teams. He/she will serve a subject matter expert at matrix teams and influence development strategy based on scientific data.
What will you do?
- 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, analyzes and models data, and writes internal study reports.
- 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 combination products 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.
- Ph.D. with 7-10 years of relevant industry experience.
- Broad understanding of pharmacokinetics and PK/PD 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.
- Please note that our offices will be moving sometime towards the end of 2021 to Aliso Viejo, California
Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous paid time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Check out our profile on The Muse to get an inside look at our company culture. Glaukos has been named one of the Top Workplaces by the Orange County Register for the past 3 years!
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device-the iStent®-in the United States, followed by our next-generation iStent inject® device in September 2018.
In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex including sexual orientation and genderidentity, national origin, disability, protected Veteran Status, or any othercharacteristic protected by applicable federal, state, or local law.