Requistion ID: 80270
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

BACKGROUND/QUALIFICATIONS

• DDS (Doctor of Dental Surgery) or DMD (Doctor of Dental Medicine) or comparable degree.
• Proven scientific track record (PhD or equivalent).
• Minimum of 10+ years of experience in clinical research with a focus on dentistry.
• Knowledge and experience of applicable regulations for clinical investigations such as e.g. MDR, and ISO 14155.
• Medical device industry experience
• Fluent in English and at least one other language.
  The role will be based in Gothenburg/Mölndal, Sweden. We may also be open for placement in Konstanz or Bensheim, Germany. You may need to travel up to 30%.
  We will evaluate CVs on a continuous basis so make sure to send in your application in English as soon as possible.

Internal Clinical Research representation & consulting on high level clinical research topic.

External Clinical Research representation of DS on international level:

• Represent Dentsply Sirona at international scientific and professional meetings.
• Interact with customers, Key Opinion Leaders and investigators.
• Lecture and present to internal and external groups.

Oversee strategy, preparation and maintenance of processes, structures, and activities for the CoE Clinical Research:

• Ensure a process for funneling clinical studies in alignment with company needs.
• Maintain processes (SOPs) for performing clinical studies in compliance with current regulations.
• Participate in clinical audits performed by authorities as well as internal audits.

Oversee creation of Clinical data:

• Responsible for the DS clinical study program including all sponsor related activities taking place during set-up, conduct and close-out of a clinical study.
• Responsible for planning and performance of scientific communication of company-initiated studies such as poster abstracts and publications (in collaboration with investigators).
• Responsible for the management of the Investigator initiated studies (IIS) support program including review- and decision process of proposals, contracts and follow-up of approved proposals.

Manage Investigator/KOL relationships in support of clinical research activities:

• Create relationships to assure the studies run smoothly according to set timelines with high quality.

RA/QA support:

• Prepare interim reports on clinical study data as requested for e.g. product registrations.
• Oversee reporting on Post Marketing Clinical Follow up (PMCF) studies.

Scientific Support Service:

• Oversee creation of scientific content (Scientific support materials, abstracts, posters).
• Represent DS at scientific meetings and conferences.