Pharmaceutical professional with international experience offering global project management, technical and biologics development expertise. Strong team leadership and strategic entrepreneurial thinking in drug development.
Strong knowledge of development guidelines ● Able to create efficient, productive development strategies to reach key goals beating competition with the implementation of entrepreneurial thinking ● Goal digger ● International experience in leading and managing wide international cross functional teams ● Therapeutic expertise in Immunology ● PhD in molecular biology and genetics.
Core Competencies include:
• Global Program Management
• Business negotiations
• Strategic Product Profiling
• Risk Analysis
• Strategic project planning
• Due Diligence BD&L activities
• Coaching, mentoring and leadership
• Microsoft Office Suite, MS Project
Global Program Manager, Biopharmaceuticals @ Leading cross functional global international teams. Responsible for the management of clinical/ commercial global programs of biosimilar biologics. Have an overview on technical development, TechOps, clinical operations, regulatory, marketing and IP processes. Responsible for strategy planning and reporting to senior management.
Select Accomplishments:
• Successful drive of program from program approval to clinical stage
• Successful drug substance and drug product production for the start of clinical trials
• Involved in selection of strategic partnership for the end to end clinical trial execution From October 2014 to Present (1 year 3 months) CEO & founder @ DiaGenomi Ltd. is a young high-tech company that offers services and solutions in three different areas of molecular biology. The genetic analysis of breast and colon cancer samples, enable physicians to more effectively and quickly adapt treatment decisions for individual patients. An important step towards personalized medicine is the genetic test of the cardiovascular system which gives individuals guidelines for a healthier life style and reduction of potential cardiovascular complications.
Select Accomplishments:
• Receiving venture capital
• Launching 4 products under MyRISQ brand worldwide, opening company in UK and US
• Won medal for Innovation from Slovenian Chamber of Commerce 2013
• Won medal for Innovation from Slovenian Chamber of Commerce 2012
• Won award for best StartUp 2011
• Won award for best business plan Technology park 2011 From October 2010 to Present (5 years 3 months) Head of Analytical Laboratories Drug Product development, Biopharmaceuticals @ Managing 23+ employees. Responsible for the co-ordination of all stability samples and four specific biosimilars projects within the DP Analytics team. The development of the laboratories, employees, analytical tools, new approaches to the characterization of Sandoz products and the development of new system approaches to the delivery of key functional requirements. Implementation of new high throughput methods and automation of laboratories. Responsible for preparation of strategic drug product plan.
Select Accomplishments:
• Implementation of new high throughput methods and increasing efficiency of laboratories; first automated system fully qualified and to be used under GMP
• Negotiated lower fees with external CROs for stability studies, lowering of costs
• Organization of cross site and cross division development workshops
• Coaching and developing employees – two completed green belt certifications
• Analytical support for development of biosimilars From October 2013 to September 2014 (1 year) Technical Project Leader, TechOps, Biopharmaceuticals @ Leading cross-functional global project team, responsible for the restart of erythropoietin production at CMO. Coordination of QA, QC, RegCMC, TechDev and TechOps members and activities cross sites. Responsible for budget and milestones deliverables. Headed preparation of capital appropriation requests for investment above 10m USD.
Select Accomplishments:
• Successfully lead the restart of biosimilar production at CMO
• One of 10 selected for STEP (Sandoz excellence programme driven by QA initiative from 5.10.2012 till 1.5.2013) From October 2012 to September 2013 (1 year) Assistant researcher @ Co-managed undergraduate and graduate classes in molecular biology at Faculty of Medicine. Kicked off courses of entrepreneurship in medical and pharmaceutical science. Co-developed research protocols for ongoing research in the field of cancer research and biologics and wrote grant applications to fund continuing research.
Select Accomplishments:
• Winner at Novartis regional BioCamp 2011
• Introduction and creation of courses of entrepreneurship in applicable sciences at Faculty of Medicine and Faculty of Pharmacy. Teaching students of business plan preparation and pitching From June 2011 to August 2013 (2 years 3 months) Senior researcher @ Working in the project group of Labena Ltd as a senior researcher. Research focused on designing new genetic tests used in clinical practice. From January 2011 to July 2013 (2 years 7 months) DCO @ Working as a Doping control officer for Slovenian antidoping agency. From September 2010 to February 2013 (2 years 6 months) Mentor @ Global is a continuation of the Start: up Slovenia, mainly aimed at young and internationally oriented high-tech startup companies based on knowledge of high value added. The program aims to provide appropriate support to selected enterprises in the rapid global growth and entry into foreign markets, both in terms of infrastructure and in terms of skills, mentoring and international networking. From April 2012 to 2013 (1 year) Consultant for Balkan Region @ Managed and aligned strategy for market entry and searching for KOLs in respective region. Performed comprehensive site visits and support FujiFilm team launching products in South European area.
Select Accomplishments:
• Successful launch of FujiFilm life science products in market of Slovenia, Croatia, Serbia and Bosnia
• Increased visibility of FujiFilm in selected region
• Involved in selection of new life science partners to widen portfolio and managing due diligence assessments From April 2010 to September 2012 (2 years 6 months) Master of Pharmacy, Research fellow @ Center for Functional Genomics and Bio-Chips (CFGBC) was opened in June 2005. It was established by the Slovenian Consortium for Biochips, the network of Slovenian academic institutions, research institutes, clinical centers and pharmaceutical industry. CFGBC is a part of Institute of Biochemistry, Faculty of Medicine, University of Ljubljana. From February 2006 to June 2011 (5 years 5 months) Global BioCamp @ From 2011 to 2011 (less than a year) Basel Area, SwitzerlandLek Regional BioCamp @ First regional BioCamp Alpe-Adria, which was held by Lek, a Sandoz company, in Ljubljana with 35 of the most promising young science students from the Alpe-Adria region.
Individual winner From 2011 to 2011 (less than a year) Research fellow @ Invited by F.Lasne, French Anti doping agency to learn the IEF method for detection and analysis of endogenous and exogenous erythropoietin. Method transfer to Slovenian Faculty of Medicine, to detect EPO isoforms in breast cancer patients. From October 2008 to November 2008 (2 months) Research fellow @ From February 2008 to August 2008 (7 months) Research fellow @ Member of A.J. Sytkowski research group. Research focused on erythropoietin and its mutants (R103A). Focus on non-hematopoietic effects of EPO. In vitro testing and lab scale production of EPO mutants. From February 2008 to August 2008 (7 months)
CEED Top Class @ CEED - Center for Entrepreneurship and Executive Development From 2012 to 2012 PhD, molecular biology, erythropoietin, cancer @ University of LjubljanaMaster of Pharmacy, Biotechnology, Molecular Biology @ Univerza v Ljubljani From 2000 to 2005 Gimnazija Poljane From 1996 to 2000 Klemen PhD is skilled in: Biotechnology, Cancer Research, Molecular Biology, Science, Genetics, Pharmaceuticals, Biochemistry, Cancer, Research, Life Sciences, Start-ups, Strategic Planning, Entrepreneurship, Product Development, Business Strategy
Websites:
http://www.diagenomi.eu,
http://www.myrisq.com