Align Technology is a global medical device company that pioneered the invisible orthodontics market with the introduction of the Invisalign system in 1999.  Today, we develop innovative, technology-rich products such as Invisalign aligner treatments, iTero™ intra-oral scanners, and OrthoCAD digital services to help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients.

Align Technology, Inc. has a new position for a leader of clinical affairs, who can help drive change and shape our future roadmap.

Reporting to the VP Product Innovation, we are looking for a senior leader who has experience running clinical affairs groups in dental/orthodontic or related fields.

• The ideal candidate would have expertise with low risk Class II medical devices and will have the ability to make study decisions accordingly.
• This position will act as the subject matter expert when making study decisions and will guide the team in the right direction.
• Ideal candidate should be able to apply the right model for each study based on risk and therefore must have strong experience with running various studies such as preference studies, IRB studies and RCT’s. They  will act as the subject matter expert and will mentor various groups such as engineering, clinical, and regulatory on the right approach for different studies.
• They  will address key strategic issues to ensure efficient execution of clinical development plans.
• In addition, this person will also direct the design, development and evaluation of technical infrastructure to expedite clinical studies.
• They will ensure accurate resource forecasting and allocation, create a system to track efficiency of clinical studies and manage/mentor the clinical affairs group to be a world class organization. 

• 10+ years relevant experience in dental/orthodontic fields preferred.
• Highly familiar with IRB, RCT and post launch studies both in US and international space. Able to apply the right model to the right study based on risk.

• Highly familiar with legal and regulatory aspects of clinical research. 

• Responsible for clinical studies from inception to completion. Manages to expected timelines, adjusts recruiting and/or study logistics to meet goals.
• Strong clinical knowledge in dental (Ortho ideal) that allows for “hitting the ground running.”
• MS or equivalent experience in related field.

Personal attributes:

• Proven and strong people manager who can educate, mentor and develop people.
• Strong networker who can recruit and motivate participating clinicians.
• Team player with excellent interpersonal and communication skills who can influence with and without formal authority
• Strong leadership capability, takes actions, drives for results and holds self and others accountable.
• Demonstrated ability to identify customer needs and create solutions to meet those needs.
• Strong analytical skills, detailed oriented and ability to make sound strategic decisions.
• Is a continuous learner who demonstrates a positive, “can do” attitude.

All your information will be kept confidential according to EEO guidelines.