Do you have a passion to provide clinical study expertise and leadership within a Diagnostics Business? Can you deliver an exceptional clinical study oversite and strategy to bring point of care products to market? If so, consider a career with Sekisui Diagnostics.
As a Clinical Project Lead you are the catalyst for developing the strategy and executing the delivery of Sekisui’s clinical evidence for your assigned products and programs. In your 5+ years of experience, you’ve developed strong project management skills that will be used to ensure success of clinical studies by managing all major aspects of strategic planning, design, organization, implementation, and delivery of clinical projects assigned. You will use your strong strategic, analytic, and critical thinking skills as you demonstrate your knowledge of IRB, FDA, ICH-GCP and OUS Standards and Regulations to navigate complex situations and make decisions, then drive to action. Your experience with medical devices and deep understanding of the health care industry will bring value as you work cross-functionally with project management, regulatory affairs, research &development, and marketing to drive growth of the business and bring new products to market.
You should expect approximately 25% travel, foreign & domestic. Experience with dual 510K CLIA waiver and within an IVD business is a plus.
Who we are:
At Sekisui Diagnostics, we help improve patient outcomes by doing what we’ve always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at both a regional and product level.
Sekisui Diagnostics offers a competitive compensation and benefits package
As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.
Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.