Senior Project Manager with over 20 years’ experience of pharmaceutical development. As project manager I have worked intensly with designing clinical development plans, all from phase I to market. I also hold a considerable expertice in outsourcing to, and managing of, external partners such as contract research organisations and consultants. I strongly believe in delivering high quality results as efficient as possible. During my professional career I have worked in numerous teams and have developed excellent skills in creating a good working atmosphere. I would love to see my future role as project manager in a small to mid-size company which work closely with external partners. . Working style: By using my social skills and easy going way, I meet the challenges with a good sense of humor and believe in leadership based on collaboration, integrity and honesty. Being an inquisitive person who loves to solve problems, I always try to find ways to improve so that tasks and problems can be solved in a more efficient way. Working experience: I have over 20 years’ experience within clinical development. I have conducted individual clinical trials, all from small phase 1 trials to large (>80 000 subjects) phase 4 trials. The last 5 years predominantly worked with designing full clinical development programs. Working at both CROs, small biotech and larger pharmaceutical companies have given me good insight in a broad variety of organisations. Therapeutic areas include immunology, vaccines and dermatology
Looking for new opportunities
Since September 2014
I am looking for new interesting contracts or positions. Area of expertice are project management, outsourcing, clinical trial design and conduct.
International Clinical Project Manager
April 2009 --- August 2014
Responsibilities • Design of several clinical development plans (according to EMEA/FDA regulations) of both topical and systemic drugs for Psoriasis, Atopic dermatitis and Itch. • Project management (including budget and time lines) of several top priority clinical development projects from pre-clinic to clinical development. Reporting of progress to management board. • Member of working groups defining responsibility split between clinical operations and regulatory affairs and also clinical development and Chemistry, Manufacturing and Control of drugs Major Achievements • Successful design of Development Plans for a topical psoriasis cream, a topical AD cream, a systemic psoriasis small molecule, and a two topical anti-itch formulations. • Outsourcing and management of a large international phase 2a psoriasis trial. Leo Pharma is a mid-sized Danish pharma focusing on dermatology.
Clinical Development Manager
January 2006 --- March 2009
Responsibilities: • Design of clinical development plans • Design and full project management of all clinical activities within seborrhoeic dermatitis and lupus erythematosus. Including several international multi-centre phase II/III Trials (2 000 patients), and phase I trials. • Full management of CROs including budget, task specifications, approval of all trial related documents and ongoing study management. • Advisory expert in scientific advisory meetings with CA and EMEA, pre-IND conferences with FDA and Orphan Drug Designation applications for EMEA and FDA. • Development of SOPs and IBs • Organising Investigators Meeting Major achievement: • Starting and finishing a pivotal phase III trial on time and budget (7 countries, 41 sites and 500 patients) Astion Pharma is a small dermatological biotech company
Senior Medical Advisor
February 1999 --- December 2005
Responsibilities: • Design and full project management of clinical activities. Including 3 phase III international multi-centre trials (930 patients), 1 phase I/II trial, 1 phase I trial (first in man). • Full management of CROs • Development of trial related documents • Manager for the SOP working group) • Participation as clinical trial expert in pre-IND procedures. Major achievements: • Completion of several phase III trials on time and budget, establishing and leading internal project teams with experts from all relevant functions in order to improve trial management. Statens Serum Institut is a Danish state owned pharmaceutical company which develops vaccines and diagnostics
Clinical Trial Manager
January 1998 --- July 1999
Responsibilities: • Design and project management of clinical trials in Sweden and UK. • Writing clinical trial reports and SOPs according to ICH guidelines. Major achievements: • Finalisation of a phase III trial including report.
Clinical Trial Manager (CTM)
January 1992 --- November 1996
Responsibilities: • Operational management of a large multi-centre phase IV Pertussis vaccine trial (1400 centres in Sweden and 83 000 children recruited). Including design of protocol, CRF, data base, monitoring plan, reporting procedures • Education of CRAs and acting as CRA Lead • Regular reporting of trial activities and quality to steering committee Major achievement: • Designing the Pertussis vaccine trial risk based monitoring plan for 1400 sites approved by NIH. Hylae Clinical Research was a small Swedish CRO
Licentiate of Science in Biochemistry from Lund University in 1991