Danaher Corporation Director, Clinical Affairs in Bronshoj, Denmark
The Director Clinical Affairs plans, implements and manages clinical trials and influences study design and interprets results. She/He defines clinical trial protocols, standard operating procedures (SOPs) and case report forms (CRFs) for use in clinical trials operations.
The Clinical & Medical Affairs (CMA) function works to develop and implement the CMA strategy circling around Patient Centricity, Clinical & Science, and Partnerships.
Setting the strategic direction for the Clinical Affairs team
Development and implementation of Radiometer’s clinical evidence strategy and clinical study execution plan across the product portfolio and provide leadership on the clinical strategic areas and decisions
Line management responsibility of the Clinical Affairs organization based in Finland, Poland and Denmark
Ensure proactive clinical representation in core team meetings and activities
Provide scientific, technological and medical knowledge and expertise for the clinical research aspects of all projects
Maintain clinical expertise in field of work, with strong working knowledge of regulatory affairs
Work closely with the C&MA leadership team and provide strategic direction to support timely and on-budget development and execution of the clinical development program
Lead and develop the Clinical Affairs team successfully, including but not limited to performance management, talent management and training
Accountable for understanding the external healthcare agenda
Accountable for building a network externally to support Radiometer, and is seen as a trusted partner with high ethical standards and integrity
Budget responsible in the Clinical Affairs team and responsible for delivering on-budget planning and execution of the clinical development program
Assure that all Clinical deliverables are of correct quality and in accordance with written procedures and policies and current legal requirements and internal standards
Development and optimization of relevant processes within Clinical Affairs
Master of Science or comparable within relevant scientific field
10 + years of experience in the clinical field preferably from the Medical Device industry within Clinical Affairs
5 + years of leadership experience preferably within Clinical Affairs from the Medical Device industry
Excellent knowledge and understanding of Clinical Research, GCP, and current legal requirements and standards within Clinical practice
A solid understanding of FDA regulations on Good Clinical Practice, Declaration of Helsinki, and International Conference on Harmonization requirements
Good IT skills within PowerPoint, Excel, Word.
Able to communicate fluently in English, in written and spoken
Strong analytical, strategic and communicative skills
Proactive, excellent planning and cooperative skills
Available for a travel activity up to the 40% (domestic and international)
Make an impact on life.
The difference between life and death can be just a few minutes. Radiometer’s diagnostic equipment is of crucial importance to doctors all over the world in their effort to diagnose critically ill patients quickly and accurately. From biotech and software specialists to financial controllers and engineers, all 3700 colleagues are committed and dedicated in their effort to make an impact on the life of others with our high-quality solutions. Radiometer’s leading position in the market has been secured over the last 50 years. Together we continue to raise the bar in acute care and constantly develop in new areas. The US-based Danaher Corporation owns radiometer.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .