Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

As we continue to grow, we are seeking a Director of Medical Affairs to be responsible for mapping current trends in Cardiology, Diabetes, Endocrinology, infectious diseases, oncology, women's health, and Acute care clinical pathways, support new product development and work closely with Key Opinion Leaders and Customers. This can be located at Raritan, NJ, Rochester, NY, San Diego, CA, or Athens, OH, or can also be a remote position.

The Director follows and maps key trends of in vitro diagnostic for acute care, diabetes, myocardial infarction, heart failure, acute kidney injury, renal failure, infectious diseases, women's health, and oncology (primarily solid tumor). This role actively engages with customers, and scientific Key Opinion Leaders, searches, and reviews current literature and attends Society and other related medical care conferences.

The Director has expert knowledge of in vitro diagnostics and clinical applications as outlined above. The Director also works closely with R&D, Regulatory, Marketing, and Sales. Working with customers to gather inbound requirements and to provide scientific leadership at educational and key business events. Strong interpersonal, organizational, and communication skills are required. Knowledge of current literature and a commitment to continued learning is also required.

• Work with the Global Head of Medical & Clinical Affairs on driving Care Pathway Mapping, working with Scientific Advisors and attending Scientific Conferences, Evaluate Medical Literature, Engage Regional KOLs, supporting education of existing products, evaluate and proposing new product candidates.

• Work with R&D/Marketing/Product Development Leaders on defining key medical requirements for New Product Development

• Provide Customer Support for meeting discussions and off-label question

• Evaluate and develop Product Safety criteria

• Attends cross-functional Portfolio meetings (R&D + Marketing) to provide care pathway updates.

• Act as the medical point of contact for the supplier as needed (evaluate questions, requests, provide medical support)

• Participate in Laboratory Society Conferences and Task Force Meetings

• Perform other work-related duties as assigned.

• Doctor of Medicine or equivalent required. Clinical experience in IVD/Clinical Pathology preferred

• Additional advanced Degree - MS or Ph.D. in healthcare, biology, medical research, etc., is a plus

• Extensive knowledge and experience in one or more of the areas of Cardiology, Diabetes, Endocrinology, infectious diseases, oncology, women's health, and Acute care clinical required

• Minimum 8+ years experience in In Vitro Diagnostics Medical/Scientific/Clinical Affairs required. Experience in a leadership role is required.

• Must have a minimum of 3+ years of supervisory experience (will lead a team of 4)

• Previous experience in clinical research studies and Regulatory submission for new product development is a strong plus.

• Demonstrated and effective interpersonal, verbal, and written communication skills required.

• Experience in developing manuscripts for publications required.

• Travel up to 20% on an annual basis is required.

Key Working Relationship

• Interacts with other Medical and Clinical Affairs personnel and department personnel from Program Management to align deliverables required for the conduct of clinical studies.

• Interacts with customers, and customer complaints luminaries, works with society leaders to stay current.

Colorado State Posting Details:This position's starting salary is between $154,000 and $308,000 per year, and it is bonus eligible. Salary will be determined by the education, experience, knowledge, skills, and abilities of the candidate, in addition to internal equity and alignment with market data. Ortho offers a comprehensive benefits package, including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, paid time off (including paid sick time) and paid holidays. All benefits are non-contractual, and Ortho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

EOE/AA Disability/Veteran

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