Dr. Eric Nawrotzky

Site Management and Monitoring of BioPharma Studies in DACH region, Site Feasibility, regulatory submissions & point of contact (HAs and ECs), contract negotiations, operational study management, leader of local teams (CRA and CTAs), budget and milestone responsibilities, implementation lead (in DACH region) for patient apps, etc.

- Management of Phase I-IIa clinical studies in various therapeutic areas (i.e. Pulmonology, Rheumatology, Nephrology & Diabetes) with internal & external units according to national & international guidelines, SOP's & client specifications - Serve as main interface & company representative for project-related communication & contact with client teams, external consultants, service providers, regulatory authorities & ethics committees - Controlling of study budgets incl. generation of contracts

• Initiation, organization and support of Phase I-IIa Clinical Trials including submission of clinical trial documents to Independent Ethics Committees and Regulatory Authorities • Implementation of work specifications based on Standard Operating Positions and ICH-GCP guidelines • Prepared and organized internal and external Site Initiation Visits, Kick-Off meetings and audits, communication among different departments • Participated in sponsor meetings and telephone conferences

· Design, set-up & execution of several scientific projects as well as Fragment-based Drug Discovery for oncology-related diseases · Org. Chem., Anal. Chem. (LC/MS, NMR, IR, UV, HPLC) · Bioanal. (Enzymassays, Immunoassays, TSA, ITC, Immunoblots, BLI) · European Patent Application /Inhibitor of an oncology disease · Supervision of pharmacy students in „Quantitative determination of drugs, auxiliaries & pollutants according to the Ph. Eur.”, management of master students & technical assistants

• Clinical Monitoring, Clinical Trial Logistics and Clinical Data Management • Regulatory Affairs • Basics of medical Pharmacology, Medical Terminology, Medical Coding • Presentation skills, effective Communication, Negotiations and Conflict Management, business and legal English

Doktorarbeit im Bereich Pharmazeutischer und Medizinischer Chemie bei Prof. Dr. Jörg Rademann über das Thema: „Methodische Entwicklung eines Formylglycin-Ligationsassays und Fragment-basierte Suche zur Identifikation neuer SHP-2 und STAT5 Inhibitoren"

· Design, set-up and execution of several scientific projects as well as Fragment-based Drug Discovery for oncology-related diseases · Organic Chemistry, Analytical Chemistry (LC/MS, NMR, IR, UV, HPLC) · Bioanalysis (Enzymassays, Immunoassays, TSA, ITC, Immunoblots, BLI)

Bachelorarbeit im Bereich Bioanalytischer Chemie bei Prof. Dr. Ralf Hoffmann über das Thema: „Antikörpermarkierung und homogener kompetitiver fluoreszenzbasierter Immunassay auf der Basis der Fluoreszenzmarker ATTO 612 Q und Cy5“ (Institut für Bioanalytische Chemie, Universität Leipzig)

Grundausbildung im Panzerartilleriebataillon in Neunburg vorm Wald, anschließend Dienst im Geschäftszimmer des Panzerpionierbataillons in Bogen