Experienced pharmaceutical physician with more than 12 years in the industry covering operational, medical and safety management of Phase I to Phase III studies. Experience with small molecules, proteins, antibodies and other biologicals. Global drug development/approval experience in CNS, Cardiology, Oncology and Orphan Diseases. Experience in adult and pediatric drug development. Line management experience of cross functional teams and responsible for the clinical and operational strategy during drug development, having actively contributed to the design and implemention of several drug development plans, leading the development up to market stage. Participated in meetings with regulatory agencies (e.g. pre IND/end of phase 2/pre NDA meetings) not only in EU but also US and participated in site and vendor audits as the clinical team member. Contributed to the successful out licensing of drug candidates in the development stage. During my career I was also actively involved in risk and safety management of marketed drugs. Published over 40 peer reviewed articles and more than 75 scientific abstracts presented at meetings.

Medical Director @ From February 2014 to Present (1 year 11 months) Medical Director @ From March 2013 to February 2014 (1 year) Groningen Area, NetherlandsHead of Clinical Research and Drug Safety @ Responsible for the clinical development plans for compounds in different therapeutic areas; Lead Pharmacovigilance and Drug Safety activities for marketed and to be marketed products; Management of Phase I to III studies in 40 countries worldwide, adult and pediatric indications; Direct Interaction with Regulatory authorities, including FDA, EMA and Health Canada; Responsible for development and overall management of the study timelines, resources, budget, risk and quality plans; Medical Responsible Officer for CTP and CSR; Interaction with Medical Affairs in terms of Phase IV studies and publication strategy; From 2009 to February 2013 (4 years) Medical Monitor @ Support to medical writing activities; Support to clinical trial management activities; Medical responsibility over study related documents (CTP, ICF,CSR) Responsibility over medical interactions with regulatory authorities, ethics committees, Clinical Trial Managers, CRAs, Investigators, CROs or any other agents; Medical and scientific input to review of clinical data, patient medical safety data and laboratory values; Participation in Data Blind Review activities and approval of study populations; Support to drug safety management activities: Timely medical review of Serious Adverse Event reports presented by the staff involved in the study and/or the Drug Safety Manager. Responsibility over the ongoing assessment of the drug safety profile, assessing the benefits and risks and identifying safety signals and safety trends. From 2005 to May 2009 (4 years) Clinical Project Manager @ Work as the clinical trial head and develop and manage timelines, resources, budget, risk and quality plans; Contribute to identification and evaluation of new centers suitable for performing our studies in healthy volunteers and patients; Support the CRAs on study related questions and serve as point of contact for managing/ answering questions relating to trial procedures and subjects eligibility; Perform ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution; Management of clinical trial materials; Responsible for set up and maintenance of the Trial Master File for assigned studies; Regularly update all trial information databases in order to manage accuracy of information; Approve all necessary study related payments; Develop and execute appropriate site and CRO/vendor audit and quality plans. Co-ordinate pre-audit activities for nominated projects. From 2004 to 2008 (4 years) Medical Advisor @ Medical Manager for several licensed products in cardiovascular, CNS and respiratory areas – preparation of medical leaflets, SmPCs reviews and scientific support to sales representatives meetings; Act as the link between med rep., clinical development and the external healthcare market; Preparation of Medical Expert Reports and Periodic Safety reports for Portugal, Spain, and other countries where the company has products. From September 2003 to December 2004 (1 year 4 months)

Master of Business Administration (MBA), Business Administration and Management, General, MBA @ UFP From 2011 to 2012 MSc, Clinical Pharmacology @ University of Surrey, UKMD, Medicine @ Universidade de Coimbra From 1995 to 2001 Teresa Nunes is skilled in: Clinical Trials, Clinical Development, Clinical Research, Pharmaceutical Industry, Drug Development, Medicine, Pharmacovigilance, Clinical Trial Management, Neurology, Oncology, CTMS, Medical Writing, GCP, Medical Affairs, Clinical Pharmacology