Polonca Andermann, Phd Email and Phone Number
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Polonca Andermann, Phd personal email
PhD molecular biologist with 20+ years experience in Clinical Operations/Development in pharmaceutical industry (big pharma and biotech) and CRO.Driven and adaptable manager with demonstrated career progression and experience including line management.Proven record as effective and esteemed team leader of global clinical operations and cross-functional teams.Strong organizational, problem solving skills, effective management of project risks and process change. Excellent communicator accross all levels, good interpersonal skills, able to collaborate and drive the decision making process.Leading by example and striving for excellence to achieve goals.In depth knowledge of ICH/GCP and clinical research regulation in multiple countries across regions.Excellent track record in planning and delivering Phase I-III clinical trials in oncology on target, according to budget and high quality standards.
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Vp Clinical OperationsNouscom Ag Jul 2023 - PresentBs, Basel-City, Ch
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Head Of Clinical OperationsBasilea Pharmaceutica Dec 2017 - Jan 2023Allschwil, Basel-Country, Ch -
Director, Global Lead Regional Clinical OperationsTeva Pharmaceuticals May 2016 - Sep 2017Tel-Aviv, Il -
Director, Head Of Europe Regional Clinical OperationsTeva Pharmaceuticals Jun 2014 - Apr 2016Tel-Aviv, Il
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Head Of Clinical OperationsGanymed Pharmaceuticals Ag May 2013 - Jan 2014• Expansion and reorganization of Clinical Operations Department to manage an extended clinical development program in oncology• Define and lead departmental process improvements and initiatives• Interact with multiple functions to ensure alignment with clinical development plans and goals• Performance management, training and mentoring of Clinical Trial Managers, CRAs and CTAs (10 direct reports)• Resource, timeline and budget planning• Development of SOPs and tools • Identify, select, and manage CROs and external vendors during execution of clinical trials• Planning and set-up of a multi centric first-in-man Phase I/II in ovarian cancer (5 countries, 30 sites)• Development of a rescue plan and handover to another CRO for a phase II oncology study
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Director, Global Clinical OperationsImclone Systems, A Wholly-Owned Subsidiary Of Eli Lilly And Company Jan 2012 - Feb 2013UsLeadership and supervision to Clinical Operations staff. Coordination of activities of multiple clinical trials and trial teams across regions. Plan and supervise overall timelines, budget, resources and progress for global and regional clinical trials. Operational leadership for a late phase biopharmaceutical compound development program in cooperation with an alliance partner. Oversight of strategies for geographic set up of studies, selection of sites, patient recruitment and retention. Selection, management and oversight of CROs and external vendors for phase I - III clinical trials in full and functional outsourcing setting. Financial planning and trial budget oversight. Participation in Six Sigma projects for improvement of internal processes. -
Director Clinical TrialsImclone Systems, A Wholly-Owned Subsidiary Of Eli Lilly And Company Apr 2009 - Dec 2011UsPlan and oversee study timelines, budget, resources and progress of a Development Program. Planning and delivering phase III clinical trials in oncology on target & according to budget. Direct and oversee CRO and vendor activities during all phases of trial conduct, continuously assess key performance and risk indicators. Trial Team Leader for cross-fuctional global teams. Timeline, budget, headcount forecast and management. Management of project risks, change control and CAPA process. Prepare and review key trial documents. Interaction with Regulatory Authorities, managing inspections and audits. Accountable for delivery of two global phase III trials in NCSLC (27 countries, 200 sites, app. 1000 patients each) in fully outsourced setting. Completed enrollment before target date.
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Senior Project ManagerIcon Clinical Research Apr 2008 - Mar 2009Dublin, IeGlobal Project Manager on a phase III trial in advanced prostate cancer (32 countries, 200 sites, 600 patients). Main liaison for study sponsor. Line manager for 6 regional Project Managers (in-house and remote), 40 indirect reports. Organization and conduct of meetings with clients, third parties and internal team. Global coordination of central laboratory service providers. Supporting business development in preparation and presentation of proposals, bid defense meetings with clients. Set-up and delivery of clinical trials within timelines and budget, resource allocation, budget review, study document development, inspection and audit review. Training of Lead CRAs and Project Managers. -
Clinical Project ManagerIcon Clinical Research 2004 - Mar 2008Dublin, IeOverall cross-functional project responsibility for regional and global clinical trials from start-up till data base lock and close-out involving multi-regional remote teams. Regional Project Manager EU (90 sites, 18 countries) for three global phase III trials in prostate cancer. Project Manager for two phase II trials in NSCLC and colorectal cancer in EU from set-up to data base lock. Leadership of CRA team during study set-up, monitoring and close-out (8 EU countries and South Africa) on a global phase III breast cancer trial. Line manager for 10 direct reports. Mentor and coach for Lead CRAs and CRAs. Business development activities and client business meetings.
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Lead Clinical Research AssociateIcon Clinical Research Jan 2001 - Dec 2003Dublin, Ie
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Clinical Research AssociateIcon Clinical Research 1999 - 2001Dublin, Ie
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Postdoctoral FellowInstitut Pasteur, Paris Oct 1995 - Sep 1999Paris, FrHuman genetics, molecular biologyMolecular biology of Usher syndromeIdentification of cellular proteins interacting with myosin VII using yeast two hybrid system. -
Phd Research / Pre-Doctoral FellowThe Mount Sinai Hospital, New York Sep 1991 - Jun 1995New York, Ny, UsPhD thesis in molecular biology: The role of the cell cycle protein Pendulin in Drosophila melanogaster and its related proteins Srp1 in Saccharomyces cerevisiae during cell proliferation.
Polonca Andermann, Phd Skills
Polonca Andermann, Phd Education Details
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University Of TübingenMolecular Biology / Genetics -
University Of TübingenMicrobiology
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University Of LjubljanaBiology
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University Of Ljubljana
Frequently Asked Questions about Polonca Andermann, Phd
What company does Polonca Andermann, Phd work for?
Polonca Andermann, Phd works for Nouscom Ag
What is Polonca Andermann, Phd's role at the current company?
Polonca Andermann, Phd's current role is VP Clinical Operations, Head of Clinical Operations, Head Clinical Trials Oncology.
What is Polonca Andermann, Phd's email address?
Polonca Andermann, Phd's email address is po****@****lea.com
What schools did Polonca Andermann, Phd attend?
Polonca Andermann, Phd attended University Of Tübingen, University Of Tübingen, University Of Ljubljana, University Of Ljubljana.
What skills is Polonca Andermann, Phd known for?
Polonca Andermann, Phd has skills like Clinical Trials, Cro, Clinical Development, Oncology, Clinical Research, Ich Gcp, Ctms, Clinical Operations, Gcp, Drug Development, Biopharmaceuticals, Molecular Biology.
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