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Table of contents Page Welcome address 1 Organizing team 2 Introduction to clinical research 4 Session I: All you need to know about clinical research 5 Session II: Clinical research management 9 Session III: Monitoring clinical trials: CRA s perspective 13 Session IV: Medical affairs and communication 15 Video 18 Workshops 20 Sponsors 21 Supporters 23 Acknowledgements 26 Useful resources 27 Feedback / Save the date 29 Program 30 Page 1

Welcome Address Dear Colleagues, On behalf of the Career Day organization team it is our pleasure to welcome you to the Career Day Clinical Research. The Clinical Research sector is one of the most pursued career paths of DKFZ alumni. Therefore, our team aimed to organize this event to give you an insight into all aspects of the Clinical Research world: For example, could you name all the phases of Clinical Research that are necessary to bring a new drug into the market? Do you recognize the numerous job titles associated to it? Are you familiar with any clinical trial being developed in an academic institution? By the end of this day we hope you get the answers and find out for yourself: Should I consider a career path in Clinical Research? What are the entry points and which companies can I apply to? The organization team would like to thank our project sponsor Dr. Barbara Janssens for giving us the opportunity and means to organize this event as part of the hands-on project management training. A big thank you goes to Marion Gürth of the DKFZ Career Service who greatly supported us with her know-how. We highly appreciate that Professor Dr. Baumann is opening our event today. And finally, a big thanks to every DKFZ personnel who supported the organization of this event (page 26). Our team put a lot of effort in selecting and inviting excellent speakers! We were truly amazed by their generosity in providing their time and knowledge to help us with our future careers. We also highly appreciate the speakers who enriched our program by participating in a video to give an insight into their career paths. A special thanks goes to our team members (page 3) who were restless and have done a spectacular job organizing this event. Thank you for your time, enthusiasm and commitment. Let s get started and enjoy the day by listening to our amazing speakers, joining roundtables and meeting experts in our networking section. Nádia Correia and Andrea Barnert Coordinators of Career Day Clinical Research Page 2

Organizers Project Sponsor: Dr. Barbara Janssens Coordinators Speakers Team Nádia Correia & Andrea Barnert Kalliopi Pervolaraki, Juliane Buhl, Jagoda Wrobel, Michelle Da Silva Liberio Marketing team On site Team Azer Aylin Acikgöz, Jens Langstein, Antonino Pane Tanvi Sharma, Tobias Hein, Elizabeth Alwers Page 3

Introduction to Clinical Research Career Track Clinical Research Clinical Research includes a broad variety of career options closely related to clinical trials. There are many entry positions for CRAs (clinical research associates), Clinical Monitors and Trial Monitors in Pharma Industry, CROs (clinical research organizations) and government agencies. The main function of a CRA is to monitor clinical trials, which are research studies of human subjects that are designed to investigate the safety, efficacy and effectiveness of novel therapeutics, such as cancer drugs. CRCs (Clinical Research Coordinators) are responsible for conducting and managing clinical trials. Medical Affairs act as a bridge between development and commercialization of products in biopharmaceutical industry. Typical jobs in Medical Affairs are related to medical communications/publications, medical science liaisons (MSLs), and medical information. Regulatory Affairs professionals usually have to ensure that their companies comply with all of the regulations and laws applicable in the respective country. Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Typical roles are: 1. CRA (Clinical Research Associate) 2. Clinical Manager / Study Manager / Clinical Project Manager / Coordinator 3. Quality Control Specialist / Quality Assurance Specialist 4. Drug Safety / Medical Affairs / Pharmacovigilance 5. Medical Writer 6. Biostatistician Image www.immunology.org/careers/why-study-immunology Page 4

Introduction to Clinical Research It s all about Clinical Trials An Overview Clinical trials are research studies of human subjects that are designed to investigate the safety, efficacy and effectiveness of novel therapeutics, such as cancer drugs. First, preclinical studies including extensive in vitro (e.g. cell culture) and in vivo (animal) experiments are necessary to obtain pre-clinical data. Once promising pre-clinical data are available, a clinical trial can be designed. Most drugs have to be tested in healthy volunteers first, but cancer drugs are often directly tested in cancer patients because of ethical considerations not to expose healthy people to the cytotoxic side effects of many cancer drugs. There are three main phases in clinical trials (phase I to III), which differ in the purpose as well as in the amount of patients enrolled. However, some trials have an earlier stage called phase 0, and there are some phase IV trials done after the drug has been licensed. Clinical trials can be categorized into two groups: clinical trials testing pharmaceuticals (AMG-study) following the German law on pharmaceuticals (Arzneimittelgesetz) or clinical trials testing medicinal products (MPG-study) according to the German law on medical products (Medizinproduktegesetz). Clinical trials can either be of commercial or noncommercial character. Often pharma companies conduct clinical trials with the intention to have their novel drug approved for open use. Once the pharma company supplies the drug and finances to conduct the clinical trial, this is named a commercial clinical trial. So called Investigator Initiated Trials (IITs) are not financed by pharmaceutical companies, however the drug might still be supplied by a pharma company to be used in the IIT. Each clinical trial has to define endpoints. In the oncology field these endpoints include OS: Overall Survival, PBS: Progression Free Survival; EFS: Event free survival; CR: Complete Response; PR: Partial Response. Analysis of these endpoints will finally allow assessing the therapeutic efficacy of novel pharmaceuticals compared to the so far standard of care. Accompanying the clinical trial can be a translational research part, which tries to elucidate the molecular treatment-induced effect of the tested pharmaceutical. This research analysis can be useful to detect molecular biomarkers (such as expression of a certain molecule/pathway, frequency of certain cell populations or gene marker), which are of prognostic value regarding the administration of the novel pharmaceutical. Image www.blufitrecovery.com/wp-content/uploads This summary is in part written by the Career Day Organizing Team 2016 without claim to completeness. Page 5

Speakers profiles, Session I Agata Bloswick Position: Senior Director Project Management Organization: Covance Contact: Scientific background: MSc in Chemistry (2006) at the Jagiellonian University, Krakow; CRA and Clinical Project Manager at monipol sp. (2006-2010), Senior CRA at Worldwide Clinical Trials, Inc. (2010-2011), Clinical Operation Leads at Pfizer (2011-2012), Global Clinical Project Manager and Clinical Global Director at Quintiles (2012-2017) and currently Senior Director Therapeutic Delivery at Covance. Could you briefly list your main responsibilities? Oversight of the large-scale mega-trials and global programs; contributing to the Therapeutic Area; commercial, operational, medical and scientific leadership and direction; leveraging expertise from other functions as required; leading portfolio growth and delivery; engaging with Covance s leadership to help drive and implement Therapeutic area-specific initiatives; helping to define and implement the TA vision and strategy; translating this into key initiatives and priorities and contributing to the process improvement initiatives around the organization. Why did you choose this career path? I was interested in the drug development path and research but I was not fit for laboratory work. Clinical trials allow for this (to continue to be involved in research but at a different level). What skill sets from academia are the most helpful at your current job? Critical thinking. Are there any soft skills that you find particularly important? Communication, critical thinking, teamwork and self-motivation. Do you recommend any courses/trainings? Basic GCP course as a start. There are multiple post-graduate degrees in clinical trials if you re serious in investing time and money in this career path. This might not be necessary though. What do you think was the crucial factor for you to get your current job? For my first job, my boss was impressed with my DKFZ experience! This helped me to get my first CRA role. For my current and 2 past ones, full LinkedIn profile, as I was scouted by internal company recruiters. What tip would you give to young scientists? If you like the laboratory work, this job is very different. In my daily work I do more people and financial management than science, so if you re passionate about pure science, this may not be for you. You need to ask yourself what would you like your job to be. If the answer is computer, phone, travels and meetings, with some science in theory, it may be for you! Page 6

Stefan Pusch Position: Staff Scientist / Deputy Head Organization: DKFZ Contact: Speakers profiles, Session I Could you briefly describe your academic path and scientific background? I graduated end of 2008 as biologist at the Max-Planck Institute for Plant Breeding Research and the University of Cologne. Thereafter I started my PostDoc at the DKFZ in the group of Prof. Dr. med. Andreas von Deimling. Could you briefly list your main responsibilities? Conduct research on brain tumors, supervise technicians and students, initiate and coordinate cooperations, acquire and organize funding, translate findings into clinical relevant applications, patent them and help to develop them further in collaboration with companies. Why did you choose this career path? When I finished my PhD I searched for a job in which I would be able to translate some of my findings into something beneficial for society. Within the Clinical Co-operation Unit Neuropathology, I found a possibility to conduct this kind of translational science. In the past years we generated several techniques relevant for diagnostics and we were able to develop a drug candidate together with Bayer which is currently in clinical trial. Due to this high success rate in translation, I decided to stay within this career path. What skill sets from academia are the most helpful at your current job? I was trained as general biologist with a focus on botany, so today I am far away from my initial training. The skills that helped me most are biochemistry and molecular biology. Are there any soft skills that you find particularly important in your current position? To my opinion, networking is the most important skill for research. Nowadays the scientific methods became so complex that no one can handle all of them alone. So networking with the right people equipped with the complementary skills needed for your project is the key to success in science. Do you recommend any courses/trainings? I can only recommend training courses on communication and self-organization. Both skills are very important if you want to run your own project or research group. The better you are organized and the better you can communicate your ideas to your colleagues, the better the whole project / group will work. What do you think was the crucial factor for you to get your current job? On this issue I got really honest feedback from my supervisor. I was invited because my skills and training somehow fitted the position. I got the job because of the interview and the fact that I showed interest in the job by calling after an appointed time. So I received the job mainly due to good communication. Page 7

Speakers profiles, Session I Lukas Bunse Position: MD postdoc and PhD Student Organization: DKFZ Contact: Could you briefly describe your academic path and scientific background? I studied medicine in Heidelberg at the University College London (UCL) 2009-2016. From 2013-2014 I was a research fellow at the Harvard Medical School, Boston, USA. From 2012-2016 I conducted my MD thesis at the DKFZ, where I worked on immunotherapeutic strategies to treat malignant brain tumors. Since 2016 I am continuing my work as a PhD student designing translational research programs for IITs and establishing cellular therapies and combinatorial treatments for brain tumor patients. Could you briefly list your main responsibilities? On top of my PhD project I design translational research programs for multicenter IITs, work on preclinical humanized animal models to improve clinical translation, and support MD and PhD students. Why did you choose this career path? As clinical scientist, I am enthusiastic about the possibility to accompany strategies from bench to bedside. I get excited by novel technologies and the academic flexibility to move technological or therapeutic novelties ahead. What skill sets from academia are the most helpful at your current job? Ask the right research questions and triage your scientific work as in a crowded emergency room. Are there any soft skills that you find particularly important in your current position? As research gets increasingly complex with sophisticated technologies, good team work and fruitful collaborations are inevitable. Do you recommend any courses/trainings? Everyone talks about Big Data, data management, or data scientists. I would recommend to get some basic understanding of programming and data mining. Page 8

Aurora De Ponti Position: Senior Global Trial Manager Organization: Novartis Contact: Speakers profiles, Session II Could you briefly describe your academic path and scientific background? I obtained a B.Sc. (2009) and M.Sc. (2011) from Libera Università Vita-Salute San Raffaele in Milan, Italy. After finishing my Ph.D. at DKFZ in 2015, I joined Junior Clinical Researcher STAR Program at the European Center for Clinical Research Training in Brussels and worked as a Junior Clinical Researcher Trainee at Valduce Hospital in Italy. From August 2016 I worked as Clinical Trial Administrator, and then as a Clinical Study Manager at Arena Pharmaceuticals in Zug, Switzerland. Since August 2017 I am a Senior Global Trial Manager at Novartis in Basel, Switzerland. Could you briefly list your main responsibilities? I manage all operational aspects of clinical trials (protocol writing, patients recruitment, drug supply, data review, vendor management, CRA training etc). Why did you choose this career path? My professional goal has always been to do research in order to bring novel therapies to cancer patients. This is the reason why I conducted my PhD at the DKFZ, and why I then decided to work in clinical research. For me it s the best way to contribute to the drug development, to see an impact on patients. What skill sets from academia are the most helpful at your current job? I think that the most important are ability to quickly gain new knowledge (e.g. disease areas and therapeutic indications, mechanism of action of drugs), understand a study design, data handling and review, scientific writing, project and time management (on short and long term). Are there any soft skills that you find particularly important? The most important soft skills in my current position are communication skills (both speaking and writing) and team working. These skills are fundamental. Do you recommend any courses/trainings? Yes, absolutely, any course/training/master in clinical research (e.g. Good Clinical Practice course, CRA training), both classroom and well as online. What do you think was the crucial factor for you to get your current? Networking was definitely the most important factor for me What tip would you give to young scientists? Apply to entry positions in clinical research after doing a course or training Page 9

Speakers profiles, Session II Sabine Brutlach Position: Clinical Project Manager Organization: CureVac Contact: Scientific background: Diploma in Biotech Engineering from Fachhochschule Jena 2001-2006; Diploma thesis at DKFZ in 2004; Ph.D. at the Universität Osnabrück 2006-2010; Scientist at Novartis 2005-2006; CRA at Scope International AG 2010-2012; Clinical Manager at immatics biotechnologies 2012-2014; since 2014 Clinical Project Manager at CureVac. Could you briefly list your main responsibilities? Organizing and managing all operational aspects of a clinical project while ensuring adherence to timelines, quality and regulatory requirements; Managing project issues such as budgeting, contracting, drug supply, recruitment and study progress; Interacting with CROs and other service providers; Leading cross-functional international teams. Why did you choose this career path? Because I am interested in clinical research and medical questions and this is the best way to combine those interests. I like to manage and to guide teams. What skill sets from academia are the most helpful at your current job? Following skills gained in my PhD are supportive at my current job: Pronounced quality awareness; Ability to understand biological and medical contexts; Ability to have a detailed look at medical aspects; Ability to independently handle and organize projects; working in international teams. Are there any soft skills that you find particularly important? Ability to build teams; Ability to motivate people and to clearly communicate; Self- organizational and self-motivating working style Do you recommend any courses/trainings? Best initial training is to work as CRA prior being a PM. Also general courses for GCP, Clinical Research and PM in clinical trials. What do you think was the crucial factor for you to get your current job? I have experience in a biotech company and was familiar with flexible structures and the importance of a clinical trial. Having worked as CRA before as well as a Country Manager was a plus. This enabled me to quickly become familiar with CureVac and to support them. What tip would you give to young scientists? Figure out if you like to work in a regulated environment and get in touch with clinical trials as early as possible: be involved as a researcher who provides input in case of data analysis/ methods/assays; as a CRA who monitors clinical trials or as a study nurse or study coordinator. Page 10

Carmen Lilla Position: Associate Director Medical Oncology Organization: Bristol-Myers Squibb Contact: Speakers profiles, Session II Could you briefly describe your academic path and scientific background? Pharmaceutical degree from Munich University (licensed pharmacist); PhD in cancer epidemiology from Heidelberg University/DKFZ; Post Doc at DKFZ; since 2006 in pharmaceutical industry (biotech and big pharma ). Could you briefly list your main responsibilities? Clinical trials and non-interventional studies, medical education, translational research, market access. Why did you choose this career path? Interest in medical / life sciences, oncology is a field that is very dynamic and with a high need to improve treatment options. What skill sets from academia are the most helpful at your current job? Medical/scientific background, good understanding of scientific data, statistics, epidemiology. Are there any soft skills that you find particularly important? Team-player, being flexible and eager to learn, business acumen. Do you recommend any courses/trainings? Depending on the role and background training in GCP (good clinical practice), statistics, epidemiology may be helpful. What do you think was the crucial factor for you to get your current job? Network and success in previous roles. What tip would you give to young scientists? Make use of career days, mentoring etc. to connect with people from the field you re interested in and establish your own network and just go for it! Page 11

Speakers profiles, Session II Ruth Merkle Position: Manager Technology & Clinical Liaisons Organization: Hummingbird Diagnostics Contact: DKFZ connect, Scientific background: PhD and one-year postdoc at DKFZ until 2015; R&D Manager of MammaScreen Start-up Project for one year. Since 2017 Manager Technology and Clinical Liaisons at Hummingbird Diagnostics GmbH. Could you briefly list your main responsibilities? Coordination of clinical trials: project plan, ethic vote, organization, logistics, communication, reporting; Cooperation with partners from clinic, academia or industry: identification of potential partners and KOLs, networking, communication, conferences, negotiations, project coordination; Patent portfolio: supporting patent applications, communication with patent attorneys, portfolio review Why did you choose this career path? I wanted to follow academic ideas/results to the market and don t stop after the publication. What skill sets from academia are the most helpful at your current job? Presenting, writing, critical thinking, being able to understand new information very fast. Are there any soft skills that you find particularly important in your current position? Being able to work interdisciplinary, being reliable and communicative and a structured work style. Do you recommend any courses/trainings? It is good to learn networking. No special course is needed for that. For me, BioContact and courses/lectures from EIT health were very helpful. What do you think was the crucial factor for you to get your current job? Experiences from my previous job in a start-up (clinical trials, business, patents, QM). What tip would you give to young scientists? Stay curious, be persistent and work hard! Page 12

Speakers profiles, Session III Tairi Aljand Position: In-House CRA Organization: PRA Health Sciences Contact: Scientific background: I obtained a B.Sc. (2011) and M.Sc. (2013) from Heidelberg University. After completing my doctoral degree at DKFZ in 2017, I started working as an In-House Clinical Research Associate at PRA Health Sciences. Could you briefly list your main responsibilities? Preparation, collection and review of documents from clinical study sites; Updating of electronic systems (electronic trial master file and clinical trial management system); Submission of the clinical study to local ethics committees and local regulatory authorities; Communication with clinical study sites; Close interaction with CRAs, regulatory affairs associates and clinical trial managers (project team). Why did you choose this career path? I wanted a job that was meaningful to me and also had clearly-defined goals. I also kept in mind that I can enjoy my job the most if the daily activities overlap with my personal set of skills. What skill sets from academia are the most helpful at your current job? Project management skills (keeping track of multiple projects at the same time), time management skills, staying goal-oriented in every situation, detailed and structured way of working. Are there any soft skills that you find particularly important? Communication skills, joy in working in a team, ability to adapt, and above. Do you recommend any courses/trainings? There are seminars and workshops offered on the Heidelberg campus occasionally (e.g. DKFZ career day, KKS Heidelberg). Online courses (e.g. on the Coursera platform) are valuable resources to get an introduction into clinical research. You can also find several offers for advanced training (e.g. courses from Pharmaakademie or Mibeg-Institut). What do you think was the crucial factor for you to get your current job? I think my interest in clinical studies and previous experience with team work. What tip would you give to young scientists? Don t be scared to take the first step. If you think that clinical research might be a suitable fit for you, then learn about this career field as much as you can. It will give you a clearer picture if it is something that you would enjoy doing and will also give you valuable know-how for your next job application. Page 13

Speakers profiles, Session III Christian Stoy Position: Senior Clinical Research Associate (CRA) Organization: PPD Contact: Could you briefly describe your academic path and scientific background? I studied Biology at Heidelberg University (2004-2010) and completed my Ph.D. at DKFZ in 2014. In 2015 I joined PPD, first as a Research Assistant and now as a Senior Clinical Research Associate. Could you briefly list your main responsibilities? Monitoring clinical trials to ensure patient safety, data quality and integrity, adherence to study protocol and Good Clinical Practice regulations. Establishing / maintaining good and strong relations with clinical study sites. Why did you choose this career path? I was looking for alternatives outside academia. Clinical research offered an interesting range of paths and opportunities for personal development with a long-term perspective. The CRA role in particular caught my interest as I like to travel and the job is very diverse. What skill sets from academia are the most helpful at your current job? Analytic and critical thinking, problem solving, an eye for detail, teaching skills. Are there any soft skills that you find particularly important? Communication, organizational skills, able to work both in a team and independently. Do you recommend any courses/trainings? There are courses available at various private institutes to become a Clinical Research Associate but PPD also offers internal trainee-cra opportunities. What do you think was the crucial factor for you to get your current job? Networking and personal skills. What tip would you give to young scientists? If you are unsure whether you should pursue a PhD or not, the CRA career might be an alternative. A PhD degree is of course a good plus for this job and many CRAs have a PhD, but you can be just as successful with a Master s degree. Page 14

Speakers profiles, Session IV Georg Isbary Position: Medical Therapeutic Area Lead CIT GI/GU Organization: Roche Contact: Could you briefly describe your academic path and scientific background? I received my medical degree in Tübingen in 2006, and in 2012 the Board Certification in Dermatology and Venereology. Since 2014 I have an Associate Professorship Dermatology and Venereology, LMU Munich and started at Roche Pharma AG as Senior Medical Manager Dermato- Oncology. What is CIT GI/GU? Cancer Immunotherapy Gastrointestinal and Genitourinary Cancers Could you briefly list your main responsibilities? I lead a medical team and have the responsibility for the local medical strategy and tactics for the cancer immunotherapy franchise, gastrointestinal and gastrourinary cancers. Why did you choose this career path? I wanted to try something new. It sounded very interesting for me to work for a company like Roche and being part of current research in oncology. Furthermore, there are great development potentialities within a pharmaceutical company. What skill sets from academia are the most helpful at your current job? Critical thinking is very important. Networking, presentation skills, resilience and others are also helpful in daily life. Are there any soft skills that you find particularly important? It is very important to be a great team player and to have good communication skills. It is important to have a strong will to push research forward and to fight for patients life, to stay curious and always to look ahead. What do you think was the crucial factor for you to get your current job? My ambition to enhance cancer patients life by developing better therapeutic options in the future is a strong motivator for me and pushes me every day. This ambition in combination with my scientific background are important factors to get my current position. What tip would you give to young scientists? If you are highly motivated, enthusiastic about clinical research and a great team player, be confident and just start this path. Page 15

Speakers profiles, Session IV Antonio Garreta Position: Global Strategic Scientific Liaison Organization: Bayer Contact: Could you briefly describe your academic path and scientific background? I studied MSc Biology (2002, Universitat Autonoma Barcelona) and MSc Biochemistry (2001, Universitat Tarragona) Dual Studies. From 2005-2009 I did my PhD at the DKFZ. I didn t do a Postdoc. Could you briefly list your main responsibilities? I am an international MSL, this means I have the same responsibilities as an MSL but within different countries. Why did you choose this career path? Because I wanted to be involved in an international environment and to work with clinical studies together with patients and medical doctors. Furthermore, I was interested to work in the drug life cycle management. What skill sets from academia are the most helpful at your current job? Presentations skills and statistics. Are there any soft skills that you find particularly important in your current position? Project management, top communication skills, flexibility, ability to travel, negotiation skills, costumer-relationship management. Do you recommend any courses/trainings? GCP/ICH, project management, presentation skills. What do you think was the crucial factor for you to get your current job? Networking, flexibility, accepting a lower salary, speaking several languages. What tip would you give to young scientists? Patience, networking, avoiding a Postdoc Page 16

Speakers profiles, Session IV Philipp Kulozik Position: Medical Scientific Liaison Manager Organization: Novartis Pharma GmbH Contact: Could you briefly describe your academic path and scientific background? I finished my Ph.D. at DKFZ in 2011. After that I worked for two years as Scientist at Proctor & Gamble. In 2013 I joined Novartis as MSL Manager. Could you briefly list your main responsibilities? Study supervision and scientific engagement partner for key opinion leaders in the field of neuroscience. Why did you choose this career path? I like to interact with a team and work highly scientific to achieve a combined goal. What skill sets from academia are the most helpful at your current job? Being able to grasp and understand scientific papers, posters etc. within a very short period of time and to discuss the content with other peers. Are there any soft skills that you find particularly important? Outgoing, flexible, scientific person who loves to travel. Do you recommend any courses/trainings? Marketing or sales experience is a plus. What do you think was the crucial factor for you to get your current job? Being at the right spot at the right time. What tip would you give to young scientists? Do not try to become a specialist in a certain field or technique, but rather apply for a job where you can gain more experience in fields that are typically not offered at a research facility as you constantly need to interact with marketing and sales functions even if you are in a medical team. Page 17

Videos Antonino Natoli Position: Site Management Lead Organization: IQVIA Contact: Could you briefly describe your academic path and scientific background? I studied Pharmaceutical Chemistry in Palermo until 2002. In 2009 I completed my PhD at Mainz University dealing with Proteomics and Biomaterials. From 2010 to 2012 I was at the DKFZ for a postdoc in Tumor Immunology (P. Kramer Group). Afterwards I conducted a six-month qualification course in Clinical Monitoring (Mibeg-Institute Medizin, Köln) and started my career at IQVIA (former Quintiles). Could you briefly list your main responsibilities? Coordinate and support a CRA team in order to assure accurate and timely completion of all contracted activities. Additionally, I have to keep track and report to the sponsor and upper management on the current study status. Why did you choose this career path? After many years of bench research, I wanted to go one step further and see drugs applied to humans. What skill sets from academia are the most helpful at your current job? Organizational and communication skills. Are there any soft skills that you find particularly important in your current position? Interpersonal skills and team spirit. Do you recommend any courses/trainings? Yes, Clinical Monitoring Course at Mibeg, Pharmaakademie or similar. What do you think was the crucial factor for you to get your current job? The training at the Clinical Monitoring Course allowed me to gain the experience needed for applying to a CRA position. Page 18

Videos Nibedita Gupta Position: Associate Medical Writer Organization: Envision Pharma Contact: Could you briefly describe your academic path and scientific background? I received a BSc in Physiology from Presidency College (2005) and MSc degree in Biochemistry from the University of Calcutta (2007). In 2012 I finished my Ph.D. in Oncology and Cancer Biology at DKFZ and started postdoctoral training at Otto-von-Guericke-University in Magdeburg. In 2016 I started working as an Associate Medical Writer for Envision Pharma, in the UK. Last month I joined Prime Global in Manchester, and continue my career in medical writing. Could you briefly list your main responsibilities? Development of abstracts, posters, presentations, manuscripts, journal response documents, discussion guides, journal grids and bibliography; QC review to ensure scientific accuracy, consistency and industry compliance; Interpretation and incorporation of internal and external review comments; Managing timelines and document versions effectively; Development and timely delivery of assigned projects; Liaising with editorial and client service team members; Communication with clients for scientific aspect of assigned projects Why did you choose this career path? I have always enjoyed scientific writing. Working as a medical writer helped me to turn my passion into a profession. What skill sets from academia are the most helpful at your current job? Data interpretation and analytical skills; Writing and presentation skills; Project and time management; Ability to freely discuss science with experts; Teamwork Are there any soft skills that you find particularly important in your current position? Communication skills Do you recommend any courses/trainings? From academic to medical writer: A guide to getting started in medical communications; DeBruin: Careers in medical writing: is medical writing right for you; Wagner: What medical writing means to me; European medical writers association; International society for medical publication professionals (ISMPP); Bloom, Knudson & Heing: A field guide for science writers; Goodman, Edwards & Langdon- Neuner: Medical writing-a prescription for clarity; You can find additional useful resources in the end of this booklet. What do you think was the crucial factor for you to get your current job? Networking primarily through LinkedIn Page 19

Workshops Andreas Eisenmenger Position: Project Manager for Clinical Trials Organization: NCT Trial Center Contact: andreas.eisenmenger@nct-heidelberg.de Short Introduction to Pharmaceutical Development and Job Profiles Roles, Responsibilities and Qualifications Dr. Eisenmenger has a leading position at the NCT Trial Center since 2006. In 2000 he received his PhD in radiation protection research (FU Berlin) and joined DKFZ as a Postdoc. In 2004 he established a workgroup for Clinical Trials at DKFZ. The interactive seminar will give a basic overview on Pharmaceutical Research and Development as well as Clinical Trials: trial types, trial phases and their prerequisites concerning roles, responsibilities and qualifications needed. Special attention will be paid to the role of project managers in clinical trials and clinical monitors (CRA). Participants should feel free to bring their individual questions concerning roles, qualifications, and possibilities for further education, being addressed in the seminar as far as possible. Participating scientists will be able to assess where their clinical or preclinical work fits into the whole process of research and development of new drugs and treatments. They will find out about qualifications needs, educational opportunities, and job perspectives offered in this field Martijn Bijker Position: Director Organization: From SCIENCE to PHARMA Pty Ltd Contact: From SCIENCE to PHARMA is the world s largest Medical Science Liaison (MSL) training company and has helped thousands of aspiring MSLs globally. The founder Dr. Martijn Bijker PhD. MSc. BSc. - has worked in the pharmaceutical industry for many years as MSL and related functions at big companies such as: Abbott, AbbVie, Amgen and Merck KGaA. Companies hire MSLs to help bring innovative new drugs to market by liaising with the top clinicians in the field. MSLs are therefore the scientific and clinical disease and drug experts working within the medical (affairs) department of a pharmaceutical or biotech company. As an MSL you should know how the drug works its mode of action (MOA); have a clear understanding of the disease and patient profiles; what the side effects of the drug are and how best to manage them and you should know everything about your company s and its competitors clinical trials and pipeline molecules. To be this scientific and clinical expert, MSL in most countries require to have a terminal D-degree (PhD, PharmD or MD). We are honoured to be hosting this webinar together with DFKZ where we will provide you with more insights into the MSL role and tips on how to transition from science to pharma to become an MSL. Page 20

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Thank you to our Sponsors Gold Gold ALWAYS CURIOUS ITHE NEXT AGINE 350 YEARS Gold Curiosity is in our DNA. Since 1668, we ve explored uncharted territory in science and technology. We can only co imagine what the next 350 years have in store. Discover more: merckgroup.com/350 z f dk t@ gh ri py Can you? Silver Silver Page 22 Career Day Clinical Research June 8th, 2018

DKFZ PhD Council There are around 550 German and international Doctoral Researchers who work at the DKFZ in Heidelberg. Amongst them, five or six are annually elected to form the PhD Council. The members of the Council serve as representatives of the student body, coordinate scientific and non-scientific student life in various ways, and foster exchange and networking between Doctoral Researchers. Doctoral Researcher networking is facilitated through involvement in the PhD Teams coordinated by the PhD Council, of which 1 in 10 Doctoral Researcher join annually. One of our aims is to improve the life of Doctoral Researchers at the DKFZ. An important part of this task is organizing social events as an escape from the daily routine, giving Doctoral Researchers the chance to meet their peers and colleagues, make friends, exchange experiences and expertise or simply relax. For example, the PhD Happy Hours are an excellent opportunity to get in touch not solely with other Doctoral Researchers, but also Postdocs and Master s students in a relaxed and enjoyable atmosphere to discuss science and personal interests. In addition, the Social Events Team and Party Team plan and organize movie nights, sports tournaments and several parties year round. We also play a role in welcoming new Doctoral Researchers to the DKFZ through the Welcome Lunch, which takes place once every month and is aimed at integrating the new Doctoral Researchers to the DKFZ community. Furthermore, we established connections between people with shared interests and support language tandems and hobby clubs. Besides creating networks and providing opportunities to forge social connections, the PhD council is also involved in other tasks. The Welcome Team makes the two PhD selection rounds per year a pleasant and informative experience for the applicants, and provides further help for newcomers once they have joined the DKFZ. The Retreat Team organizes the two PhD Retreats, which take place in Weil der Stadt each year. The Communication Team keeps the PhD Council website updated and keeps Doctoral Researchers informed with the bi-annual newsletter. And of course, all teams cooperate closely with the Graduate Office. Finally, the PhD Council also serves as a liaison between the Doctoral Researchers and the DKFZ Management Board, and represents your interests on a Helmholtz Association-wide level in the Helmholtz Juniors (HeJus). If you would like to learn more to stay informed, have any questions, or wish to help, please do not hesitate to contact us or check out our Facebook page: Phd-student-council@dkfz.de www.facebook.co/groups/dkfzphd The PhD Council 2017/2018 members (Names from left to right in the back are: Gintvile Valinciute, Florian Köhler, Michael Persicke (on the piano), and in the front: Maria Bonsack and Lucie Wolf) Page 23

PDN Network The PostDoc Network from PostDocs for PostDocs OUR MISSION The PostDoc Network (PDN) was formed to represent the PostDocs` interests and to achieve the best conditions for career perspectives and scientific output. Our main goals are to raise the visibility of PostDocs in and outside the DKFZ, to support career development and to increase social and scientific networking among PostDocs. Newsletter Career Development VISIBILITY Our website and mailing list provide general information about the PDN and offer a platform for PostDocs to communicate with each other and to discuss issues important to them. The quarterly Newsletter contains information about upcoming events and personal accounts of PostDoc experiences at DKFZ. CAREER DEVELOPMENT In collaboration with the DKFZ Advanced Training Center, the PDN organises seminars and workshops tailored for PostDocs` needs, as well as Career Days where invited speakers provide expert perspectives on how to pursue careers in industry, academia and elsewhere. Alumni and current DKFZ researchers are invited to share their personal career paths. The participants are given ample time to join round table discussions and to network with invited guests. Get Together Expertise Exchange Alumni Network NETWORKING The annual Retreat aims to encourage scientific and social interactions between PostDocs, in order to improve the research and personal experience of scientists. The monthly Lunch Talk Series was started by the PDN and the BioMed X Innovation Center to provide a platform for intellectual exchange between researchers working in diverse fields of life science research in Heidelberg. The Research Lounge let s talk science encourages scientific collaboration and discussion within the DKFZ. At monthly Get-Together events PostDocs can get useful information about life in Heidelberg and work at the DKFZ. Find more information on PDN activities on our official website: www.dkfz.de/en/postdoc-network/ To be up-to-date with current and upcoming events join our mailing list: pdn@dkfz.de PDN Committee 2018 PDN PostDoc Network PostDoc Retreat Page 24

DKFZ Alumni Association The Alumni Association strongly supports the maintenance of long-lasting personal and scientific relationships between present and former members of the German Cancer Research Center. It aims to stimulate the exchange of ideas and experiences in the ever growing DKFZ family, nationally and internationally. Particularly important target groups are young scientists, especially those from abroad that are currently (or previously) working at the DKFZ. Alumni members benefit from an attractive range of activities: publication of the Alumni Monthly Newsletter reporting on recent developments and upcoming events at the DKFZ a biannual scientific meeting at the DKFZ, as well as meet-up events e.g. during the AACR meeting or at Career Fairs supportive social and cultural activities for visiting scientists and members of the DKFZ a travel grant program for short-term visits of young scientist to the DKFZ the local Alumni Club Heidelberg organizes regular meetings, lectures and excursions to Heidelberg and nearby destinations of scientific, cultural or political interest. Alumni New Year s Reception Alumni members are eligible for an alias E-Mail-Address name@alumni.dkfz.de Contact among members is supported by the password-protected membership directory. The membership fee is voluntary (but sponsors are welcome). Current and former DKFZ colleagues are welcome to join. Please register at: www.dkfz.de/en/alumni Contact information Alumni New Year's Reception 2018: "Alaturka" Prof. Dr. Manfred Schwab (Chairman of the Board of Alumni DKFZ) e-mail: m.schwab@dkfz.de Susanne Schunk (Management Alumni DKFZ) e-mail: susanne.schunk@dkfz.de, phone: +49 (0)6221-42449 Page 25

Thank you The organizing team of the Career Day Clinical Research would like to say Thank you to everyone involved in making this day a success. thank you to the DKFZ Management Board for all their support. thank you to Dr. Andreas Eisenmenger for his workshop. thank you to the Alumni Association that generously supported us. thank you to our generous project sponsor Dr. Barbara Janssens. thank you to our consultant Marion Gürth for her time and know-how. thank you to Dr. Karin Greulich-Bode for her support. thank you to Dr. Philipp Gebhardt for his support. thank you to Dr. Celina Cziepluch for trainings supporting our hands-on Project Management. thank you to all media partners for advertising this event. thank you to the Information Technology Core Facility and especially Ms. Kurek for their support in all printing issues. thank you to Mr. Hauschild from DKFZ Casino for taking care that everyone was well fed. thank you to Mr. Harbarth and his colleagues for technical support. thank you to the safety department for supporting our Career Day. and last but not least thanks to all the speakers for their great talks! Career Service Advanced Training Postdoc Program Marion Gürth, Barbara Janssens, Karin Greulich-Bode Celina Cziepluch Philipp Gebhardt Page 26

Useful Resources Weblinks Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) www.bfarm.de (Information on licensing, Pharmacovigilance, medical devices, clinical trials, legal framework, market access and a lot of research on Pharmacogenomics, Pharmacoepidemiology, Safety of Medical Devices, Neuropsychopharmacology, Special Indications, and Biostatistics) Paul Ehrlich Institut www.pei.de Ethikkommission Medizinische Fakultät Uni Heidelberg http://www.medizinische-fakultaethd.uni-heidelberg.de/ethikkommission.106025.0.html NCT Clinical Trial Center https://www.nct-heidelberg.de/forschung/nct-core-services/ncttrial-center.html Koordinierungszentrum für Klinische Studien (KKS) http://www.kks-netzwerk.de/ Koordinierungszentrum für Klinische Studien Heidelberg https://www.klinikum.uniheidelberg.de/willkommen.2411.0.html World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects https://jamanetwork.com/journals/jama/fullarticle/1760318 Canadian Pharma and Biotechnology Committee, mostly in French but useful competency profiles for job descriptions in English www.pharmabio.qc.ca www.jobvector.de/karriere-ratgeber/berufsbilder/klinischer-monitor/ www.pharmaakademie.com/seminare/weiterbildung/klinischer-monitor/ www.cro-kottmann.de/de/clinical-research-associate-cra.html General info on clinical trials A collection of articles by Dr. Vera Madzarevic provide advice on how to obtain CRA experience and transit into clinical research. In addition, there is information on global trends and a future outlook on the field of clinical research. www.linkedin.com/today/author Biopharmaceutical Research & Development: The Process Behind New Medicines : Overview of the drug development process, which represents the major biopharmaceutical and biotechnology companies of the US. www.phrma.org (Pharmaceutical Research and Manufacturers of America) European centre for clinical research training: http://www.eccrt.com/courses Fundamentals of clinical trials: https://online-learning.harvard.edu/course/fundamentals-clinical-trials Principals and practice of clinical research: https://online-learning.harvard.edu/course/principles-and-practice-clinical-research Clinical trial management: https://www.conted.ox.ac.uk/courses/clinical-trial-management Free clinical research courses: https://www.class-central.com/tag/clinical%20research Yale center for clinical investigation: https://medicine.yale.edu/ycci/researchers/qualityassurance/stafftrain/clinres.aspx Clinical research course (EFIM): http://www.efim.org/events/clinical-research-course Page 27

Useful Resources Medical affairs A nice overview of the role and function of the medical affairs department, and further specializations within the field. www.bioprocessintl.com/analytical Regulatory affairs and pharmacovigilance Books German Society for Regulatory Affairs. The network of regulatory affairs professionals based in Germany. Includes information for continued education, regulatory job offers and internships in Germany, workshops and conference opportunities for members. http://dgra.de/ European Medicines Agency (EMA), comprehensive and technical resources of regulatory information. www.ema.europa.eu/ema/index Reinhild Eberhardt und Charlotte Herrlinger: Monitoring und Management klinischer Studien: mit ICH, AMG, MPG und EU-Richtlinien. Editio Cantor; 5. Auflage 2010; ISBN 978-3-87193-389-9. Barbara Hoffbauer: Berufsziel Life Sciences: Ein Karriere-Wegweiser. Spektrum Akademischer Verlag; Auflage: 2012; ISBN: 978-3827428769. Medical writer Good publication practice. https://www.ncbi.nlm.nih.gov/pubmed/26259067 European medical writers association. https://www.emwa.org/ International society for medical publication professionals (ISMPP) http://www.ismpp.org/ Online course on basics of medical writing: http://www.schoolforwriters.com/ Raymond Murphy. English grammar in use Job search sites https://www.indeed.co.uk/ https://www.glassdoor.co.uk/index.htm https://firstmedcommsjob.com/ Recruitment agencies https://www.paramountrecruitment.co.uk/ https://www.secrecruitment.com/homepage https://www.nonstop-recruitment.com/pharma/ Tips and tricks for entry level recruitment https://www.youtube.com/watch?v=b--fjyxuzxw&t=3s https://www.youtube.com/watch?v=b0m18xlz5l0 https://www.youtube.com/watch?v=kntfm-3n3xm Page 28

Feedback YOUR FEEDBACK is important to us! Please answer your questions at: https://www.surveymonkey.de/r/77zxtcy Save the Date CAREER DAY Project Management SEPTEMBER 28 th, 2018 German Cancer Research Center SAVE THE DATE When Expecta3ons Meet Reality Get Insights from DKFZ Alumni Deutsches Krebsforschungszentrum (DKFZ) Im Neuenheimer Feld 280 69120 Heidelberg Space for a QR code (optional) Page 29