Experience

OnDosis

• Sweden
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Chief Operating Officer

  • Oct 2019 - Present

  Chief Operating Officer at health-tech company OnDosis. OnDosis develops a new category of prescription regimens (drug-device combination), integrating oral solid medicine with intelligent, personalised dosing and digital capability to provide reassurance in disease management, supporting adherence and providing greater convenience for patients. As COO, accountable for end-to-en delivery of projects and products. Areas of accountability include project management, product development, regulatory affairs, quality assurance, clinical and medical affairs, pharmaceutical development, and supply chain. Show less



Cochlear

• Australia
• Medical Equipment Manufacturing
• 700 & Above Employee

• Head of Clinical Affairs

  • Sep 2017 - Oct 2019

  Accountable for the definition and execution of global clinical strategies for Cochlear's acoustic and craniofacial implant portfolios to meet business objectives and regulatory strategies in key markets worldwide. Accountable for clinical input through all phases of product development, regulatory submissions, interactions with regulatory bodies, and post-market surveillance activities. As head of department, accountable for the three functional areas of the department: Clinical Operations — execution of company-sponsored clinical investigations globally. Clinical Evidence Management — responsible for demonstration of clinical safety, performance and benefit of complete product portfolio (Class I-III medical devices) through clinical evaluation in accordance with MEDDEV 2.7.1 Rev. 4 and EU MDR. Clinical Audiology — Execution of pilot and pivotal clinical investigations at Cochlear's own research facility and provision of subject matter expertise during product development. Accountable for scientific marketing content. Manager of managers. Budget responsibility. Show less

• Manager of Clinical & Pre-Clinical Research

  • Dec 2013 - Sep 2017

  Accountable for global clinical and pre-clinical research at Cochlear Acoustics. Accountable for the development and execution of global clinical strategies. Responsible for clinical evaluation and medical writing. Responsible for the scientific content of research publications and scientific marketing materials. Represent the company at scientific meetings, study meetings, and industry events to present and discuss latest research with investigators and key opinion leaders. Scientific alliance manager for strategic research parnerships and key opinion leaders. Responsible for clinical input through all phases of product development, regulatory submissions, interactions with regulatory bodies, and post-market surveillance activities. Author of numerous scientific publications and presenter at scientific meetings. Show less

• Clinical Research Specialist - Implants & Surgery

  • Dec 2009 - Dec 2013

  Drive clinical and pre-clinical research and be responsible for knowledge-gathering and innovation creation within the area of acoustic implants and osseointegrated implants for retention of craniofacial prostheses. Responsible for clinical and scientific input through early research, product development, regulatory activities and post-market suveillance activities. Responsible for scientific content of literature reviews and clinical evaluations according to medical device directive and guidelines. Develop scientific marketing materials and provide product expertise and support at international conferences and other industry events. Responsible for scientific content of product literature. Medical writing. Author of scientific papers. Show less



Nobel Biocare

• Switzerland
• Medical Equipment Manufacturing
• 700 & Above Employee

• Associate Scientist, R&D Biology

  • Aug 2006 - Dec 2009

  Operational project manager for the development of a drug-device combination product (dental implant + active pharmaceutical), with operative responsibiliy for (i) development and validation of aseptic manufacturing technologies, (ii) development of quality system for GMP compliance, (iii) development and ICH compliant validation of analytical test methods, (iv) planning of pre-clinical studies and clinical dose-escalation studies, (v) regulatory submissions, incl. communication with regulatory authorities. Show less

• Research Engineer, Tissue Reconstruction & Healing

  • Oct 2003 - Aug 2006

  Product development of tissue-friendly implant technologies for improved integration. Process development and process validation, implant surface modification technologies. Pre-clinical and clinical research on biological processes at the implant-tissue interface and surrounding tissue, including osseointegration and soft tissue integration. Author of scientific marketing materials. Strategic research collaborations. Subject-matter expert osseointegration and soft tissue integration.



Ivoclar Vivadent AG

• Master Thesis

  • Feb 2003 - Sep 2003

  Master Thesis. Study of veneering composites for dental indirect restorations. Research outcome accepted for scientific presentation at the 2004 Annual Meeting of the International Association of Dental Research in Honolulu, Hawaii. Master Thesis. Study of veneering composites for dental indirect restorations. Research outcome accepted for scientific presentation at the 2004 Annual Meeting of the International Association of Dental Research in Honolulu, Hawaii.



Sandvik

• Sweden
• Mining
• 700 & Above Employee

• Internship

  • Jul 2002 - Aug 2002

  Sandvik's International Internship 2002. Sandvik's International Internship 2002.



Norran

• Sweden
• Newspaper Publishing
• 1 - 100 Employee

• Freelance journalist

  • Sep 1992 - Jan 2001

  Freelance journalist, columnist, photographer. Freelance journalist, columnist, photographer.