Director of Clinical Affairs
Managerial position with high degree of responsibility and influence at both strategic and operational levels.
Do you want to build and head our Clinical Affairs function? Do you want to provide clinical support to the international introduction of a unique liquid soft tissue marker to enable higher precision of radiotherapy? Do you want to contribute with medical input to our development pipeline?
Nanovi is a young and fast-growing medical technology company with a portfolio and pipeline of innovative liquid soft tissue markers to guide precision and enable better outcomes in radiotherapy and cancer surgery. Our first product, PetXmark™ was recently launched in the US for use in veterinary radiotherapy. BioXmark® to guide high precision in human radiotherapy is expected to be CE marked in Q3 2019. Submission for US clearance of this product is planned for early 2020.
To take a key role in the transitioning of our company to become a full-scale commercial business, we are looking for a competent and dedicated medical/clinical person as head of Clinical Affairs. Experience with medical writing and investigator initiated clinical trials as well as experience from the MedTech/Pharma industry are important success criteria. With direct report to the CEO, you will be part of a committed and dynamic management team and have responsibility for the clinical strategies for our products.
Your responsibilities and tasks
- Build and lead our Clinical Affairs function
- Review and give input to clinical protocols for Investigator-Initiated trials in accordance with Good Clinical Practices (GCPs)
- Manage day-to-day clinical operations
- Establish and maintain clinical evaluation of Nanovi devices, which include collection, appraisal and analysis of clinical data as well as medical writing
- Provide internal and external medical training
- Tactical and strategic input to development plans
- Input to risk management reviews and design control
- Clinical activities in support of post market surveillance
- Clinical assessment of vigilance cases
- Interactions with Key Opinion Leaders and Clinical Research Organizations
- Develop and execute clinical development strategies, incl. for the transition to MDR and increased requirements to e.g. clinical evaluation, vigilance and post market surveillance
Your professional qualifications
- MD, cand.polyt, cand.pharm, cand.scient or nurse with a medical writing background
- Experience in the field of cancer treatment
- Experience from the medical device or pharmaceutical industry
- Excellent knowledge of GCPs, EU/US regulations and procedures required for clinical trials
- Demonstrated track record of driving projects to completion within defined timelines
- Good communication skills and proficiency in English, written and spoken
- Experience with external partner collaborations
- Ability to work cross functional with various internal departments
Your personal qualifications
You have a strong drive. You are keen to take the lead in building an organizational function as well as long-term relations with external clinical leaders. You have a strategic mind-set and at the same time you like to be involved in hands-on execution.
Being accustomed to complex situations you have the ability to focus and prioritize among tasks. You have a high energy level and high quality standards and you are self-motivated. At the same time, you are open for input from colleagues and have a team-oriented mentality.
About the position
Nanovi can offer you an exciting and dynamic work environment with attractive opportunities for both professional and personal development. As part of our team, you will have a high degree of influence on your areas of responsibility and the possibility to contribute to the strategic development of our company.
Travel time must be expected.
You are welcome to contact CEO Jesper Boysen on firstname.lastname@example.org or mobile +45 24 65 60 33 for more information about the position and the company.
Please upload your application together with your CV in either English or Danish before February 20, 2019.
All applications will be treated confidentially. Job interviews will be held on a continuous basis through the application period and thereafter.
About Nanovi A/S
Nanovi A/S is a medical technology company that develops and commercializes innovative liquid soft tissue markers for use to guide higher precision in radiotherapy and surgery. The objective is to enable more effective and safe cancer treatments to benefit patients and reduce healthcare costs to societies worldwide.
Our portfolio and pipeline of products are based on a unique biomaterial technology platform, invented at the Danish Technical University. Nanovi is located in the DTU Science Park in Kgs. Lyngby, Denmark.
For more information about Nanovi, please see www.nanovi.com.