Clinical Supply Planning Manager

 How will you make an impact?

The Sr. Clinical Supply Manager has responsibility for assuring investigational product for any given clinical study is available at the clinical investigative site at the time needed for study use in study subjects, and in the condition required for human use, in an efficient and expedient manner.  This job will handle supply planning for all clinical studies spanning Glaukos' entire portfolio.
This includes working with stakeholders including product development / R&D, regulatory, clinical operations, biostatistics and data management, and external vendors to develop study specific product supply strategy and logistics planning and execute to the plan in a timely manner.  Coordination with internal stakeholders and other departments may be needed.

What will you do?

• In conjunction with R&D Engineering, CMC, and manufacturing operations understand investigational product characteristics, packaging methods, storage conditions, and shipping conditions conjunction with clinical research study managers, CMC and/or R&D Engineering as applicable, calculate the estimated product volume needs for all studies and clinical study retains, as applicable
• Understand from CMC and/or R&D Engineering as applicable, determine the appropriate shipping conditions of investigational product, this includes all Glaukos product studies.
• Lead the process of identifying and vetting product shipping vendors resulting in recommendations to clinical and CMC Leadership.
• Negotiating vendor contracts
• Expertise in product labeling requirements and work with the labeling department to assure adequate and compliant investigational product labeling
• Manage product packaging, labeling, storage and distribution vendors across all product lines.
• Working with study managers, biostatistics, CMC, IRT/EDC vendors and labeling, devise masked study treatment and randomization processes 
• Working with clinical research managers, monitor product supply as the study site level and assure that site inventories are maintained at efficient and adequate levels, assuring no study enrollments / treatments are delayed due to the lack of product supply
• Manage study product expiration dates to assure minimal expired product
• Work across functional groups including Clinical, Regulatory, R&D, Accounting and Quality to maintain regulatory compliance and quality of the clinical studies.
• Ability to identify potential risks and execute risk mitigation plans

How will you get here?

• Bachelor's degree in biological science, nursing, other health-related discipline, related business, or technical discipline preferred. Equivalent work experience will also be considered. 
• Minimum 12 years relevant work experience in clinical supply management, operations management, or project management with a strong preference for clinical supply management
• Current in-depth knowledge of the FDA's Good Clinical Practices guideline, clinical trials monitoring and regulatory compliance
• Current in-depth knowledge of International Clinical Research standards (ISO 14155 – Clinical Investigation of medical devices)
• Strong success record in meeting deliverables
• Strong Microsoft Office skills including Excel skills 
• Ability to forecast and manage inventory levels
• Ability to track patient enrollment 
• Excellent organization and time management skills
• Ability to manage simultaneous projects
• Ability to work with teams and lead decision-making processes in a team environment
• Exhibits personal integrity, credibility, and responsibility
• Excellent problem solving and analytical skills
• Solid understanding of medical terminology (ophthalmology terminology) is helpful
• Excellent written and verbal communicator
• Ability to influence without authority and persuade across all levels of the organization as well as with suppliers and customers, exercising a high degree of tact and diplomacy to accomplish objectives
• Good interpersonal, project management and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues 
• Ability to work well under pressure in a fast-paced, time- sensitive environment with shifting priorities and multiple deadlines
• Knowledge of quality management systems and corrective action program.
• Pharmaceutical and Medical Device manufacturing knowledge

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
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.
 

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