The Senior Scientist II - Biocompatibility is responsible for the design, execution (including monitoring) and reporting on in vitro and in vivo studies supporting the nonclinical development of new drug delivery devices, medical devices and enabling their testing in clinical studies.  These studies include biocompatibility studies conducted in collaboration with Toxicology, Chemistry, Engineering and Clinical development.

What will you do?

The Senior Scientist – Biocompatibility will:

• Establish and implement the preclinical biocompatibility testing strategy and development plan needed to satisfy clinical internal and regulatory requirements on a project basis.
• Participate in project teams meetings
• Interface with internal/external scientists from other disciplines
• Seek advice and input from regulatory agencies on the biocompatibility testing plans and data packages supporting 510K, IND/IMPD/NDA/IMPD/PLA submission.
• Evaluate published and unpublished data, providing risk evaluation on new ingredients for regulatory submissions and clinical trials in humans.
• Act as a Study Director/Monitor, establishing optimal testing requirements, implements the study, providing interpretation and authoring the research reports in compliance with GxP regulations to support the safety of new pharmaceutical agents and devices.
• Possess a comprehensive understanding of ISO-10993 and GLP regulations and requirements, including hands-on experience in conducting different study types

A.   Designs and executes nonclinical study plans            

• Establishes the development plan of nonclinical biocompatibility studies needed to satisfy clinical, internal and regulatory requirements on a project basis.
• As Study Director/Monitor, designs studies to maximize the quantity and quality of data, minimize the number of animals used and ensure adequate efficacy and safety information.
• Schedules and executes Biocompatibility studies based on project priorities to ensure orderly and timely progression within set target dates.
• Also assumes overall responsibility for the technical conduct of studies and assures that all aspects of studies are performed in accordance with ISO-10993 and Good Laboratory Practices (GLP) regulations mandated by the FDA.
• As Study Monitor, serves as key contact for outsourced studies and assures that studies are executed according to protocol, SOP and contract.
• Evaluates CROs and obtains study bids/quotes, develops study protocols.
• Reviews and summarizes study data to provide interpretation, conclusions and recommendations.

B.     Data review and reporting 

• Reviews and approves the interpretation, analysis, documentation and reporting of results of nonclinical biocompatibility studies to assure accurate safety assessments of devices and drug device combination products.
• Reviews and approves summaries of safety evaluations prepared for internal research release documents, regulatory agencies (IND summaries) and clinical investigator brochures.

C.     Interdepartmental and project team participation  

• Participates in project teams. Provides scheduling and technical input and plays an integral role in the project functional development plans.
• Communicates with the team leaders and members on a regular basis and promptly notifies functional head and team leaders of issues.
• Interface with internal/external scientists from other disciplines
• Assumes responsibility as Biocompatibility subject matter expert.

D.   Scouting, new opportunity evaluation           

• Evaluates available information/literature and provides technical expertise to assess and advise on the safety of new ingredients, compounds, acquisitions and competitor products.
• Prepares risk assessments and summaries for support of various research, clinical and regulatory activities.
• Exercises good judgement in recommending issues related to safety.

How will you get here?

• 6+ years of experience
• At least 2 years in medical device or pharmaceuticals in biocompatibility assessment role
• At least 2 years of understanding and working with ISO-10993 and GLP regulatory requirements
• Broad understanding of laboratory animal sciences, ISO-10993, Good Laboratory Practices, laboratory animal care policies and FDA regulations, is desired.
• Excellent analytical and communication skills, both verbal and written.
• Proven managerial skills to coordinate project and program activities.
• B.S. Degree in Biological Sciences and/or toxicology with 12+ years of experience
• M.S. degree in Biological Sciences and/or toxicology with 10+ years of experience
• PhD Biological Sciences and/or toxicology and 6+ years of biocompatibility

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.

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 are empowered with more diverse and enriching challenges that 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 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! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years!