Director for Center of Excellence Clinical Research

Dentsply Sirona; Bensheim; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Dentsply Sirona seeks a Director for the Center of Excellence Clinical Research to lead clinical studies and new product development efforts in an international setting. The role is pivotal in ensuring compliance with regulations while fostering relationships with key industry stakeholders. Ideal candidates will have over ten years of clinical research experience, including a deep understanding of the dental industry.

Qualifikationen

• Minimum of 10+ years experience in clinical research focusing on dentistry.
• Knowledge of MDR, ISO 14155 regulations.
• Fluent in English; proficiency in another language preferred.

Aufgaben

• Oversee all pre- and post-market clinical research studies.
• Manage relationships with Investigators/Key Opinion Leaders.
• Ensure compliance with clinical study regulations.

Kenntnisse

Management experience

Clinical research expertise

Stakeholder communication

Ausbildung

DDS or DMD or comparable degree

PhD or equivalent

Jobbeschreibung

Director for Center of Excellence Clinical Research

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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.

Director for CoE Clinical Research

We are a world leading dental company that has been innovating and producing dental products for more than a century. We have an impressive history, and our vision is to transform dentistry to improve oral health globally.

We are searching for a Director of our Center of Excellence (CoE) Clinical Research, a unique role that will allow you to be involved in new product development. You will be responsible for strategic planning, organization and performance of all pre- and post-market clinical research studies for the complete Dentsply Sirona product portfolio. This includes management of company initiated clinical studies as well as the investigator-initiated study support program. In addition, you will manage a team of employees in Sweden and the US as well as the corresponding budget in an international and dynamic environment.

As our Director CoE Clinical Research, you will be part of the Leadership team of a global Clinical Affairs Organization reporting into the Chief Clinical Officer. You will take part in the company’s innovation and new product development process and will be responsible for assuring that all company initiated clinical studies are performed in compliance with the applicable regulations, such as ISO 14155, MDR, Helsinki Declaration etc. You will play a key role in creating relationships with Investigators/Key Opinion Leaders (KOLs) in different dental specialties. Also, internal collaboration with all teams within Clinical Affairs as well as with Quality and Regulatory Affairs on compliance and alignment with post-market clinical follow-up needs will be an essential part of your role. Additionally, you will represent the company at scientific meetings and congresses.

Responsibilities

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.
  
  

Who you are?

You have a strong understanding of the dental industry and a strong clinical and scientific background. Communicating effectively with stakeholders at all levels comes naturally for you. You have a strong savvy in emerging trends, technologies and challenges within the dental industry. To succeed you need management experience in planning, organizing and reporting on clinical studies. You have proven people management capabilities and knows how to navigate in an international matrix organization.

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.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Medical Device

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