[email protected]@dkfz Speakers’ profiles, Session I Page 7 Career Day “Clinical Research” June 8th, 2018 Could you briefly describe your academic path and scientific

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Table of contents

Career Day “Clinical Research” June 8th, 2018 Page 1

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

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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”

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Organizers


Coordinators Speakers Team

Marketing team On site Team

Nádia Correia & Andrea Barnert Kalliopi Pervolaraki, Juliane Buhl, Jagoda

Wrobel, Michelle Da Silva Liberio

Azer Aylin Acikgöz, Jens Langstein, Antonino Pane

Tanvi Sharma, Tobias Hein, Elizabeth Alwers

Project Sponsor: Dr. Barbara Janssens

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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

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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 non-commercial 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.

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Speakers’ profiles, Session I


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!

Agata Bloswick

Position: Senior Director Project Management Organization: Covance

Contact:

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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.


Conduct research on brain tumors, supervise technicians and students, initiate and coordinate co-operations, acquire and organize funding, translate findings into clinical relevant applications, patent

them and help to develop them further in collaboration with companies.


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.


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.


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.


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.

Stefan Pusch

Position: Staff Scientist / Deputy Head Organization: DKFZ

Contact:

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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.


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.


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.


Ask the right research questions and triage your scientific work as in a crowded emergency room.


As research gets increasingly complex with sophisticated technologies, good team work and fruitful collaborations are inevitable.


Everyone talks about Big Data, data management, or data scientists. I would recommend to get some basic understanding of programming and data mining.

Lukas Bunse

Position: MD postdoc and PhD Student Organization: DKFZ

Contact:

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Speakers’ profiles, Session II



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.


I manage all operational aspects of clinical trials (protocol writing, patients´ recruitment, drug supply,

data review, vendor management, CRA training etc).


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.


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).


The most important soft skills in my current position are communication skills (both speaking and

writing) and team working. These skills are fundamental.


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


Apply to entry positions in clinical research after doing a course or training

Aurora De Ponti

Position: Senior Global Trial Manager Organization: Novartis

Contact:

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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.


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.


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.


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.


Ability to build teams; Ability to motivate people and to clearly communicate; Self- organizational and self-motivating working style


Best initial training is to work as CRA prior being a PM. Also general courses for GCP, Clinical

Research and PM in clinical trials.


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.


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.

Sabine Brutlach

Position: Clinical Project Manager Organization: CureVac

Contact:

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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”).


Clinical trials and non-interventional studies, medical education, translational research, market access.


Interest in medical / life sciences, oncology is a field that is very dynamic and with a high need to

improve treatment options.


Medical/scientific background, good understanding of scientific data, statistics, epidemiology.


Team-player, being flexible and eager to learn, business acumen.


Depending on the role and background training in GCP (good clinical practice), statistics,

epidemiology may be helpful.


Network and success in previous roles.


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!

Carmen Lilla

Position: Associate Director Medical Oncology Organization: Bristol-Myers Squibb

Contact:

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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.


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


I wanted to follow academic ideas/results to the market and don’t stop after the publication.


Presenting, writing, critical thinking, being able to understand new information very fast.


Being able to work interdisciplinary, being reliable and communicative and a structured work style.


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.


Experiences from my previous job in a start-up (clinical trials, business, patents, QM).


Stay curious, be persistent and work hard!

Ruth Merkle

Position: Manager Technology & Clinical Liaisons

Organization: Hummingbird Diagnostics

Contact: DKFZ connect,

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Speakers’ profiles, Session III



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.


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).


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.


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.


Communication skills, joy in working in a team, ability to adapt, and above.


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).


I think my interest in clinical studies and previous experience with team work.


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.

Tairi Aljand

Position: In-House CRA Organization: PRA Health Sciences

Contact:

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Speakers’ profiles, Session III



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.


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.


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.


Analytic and critical thinking, problem solving, an eye for detail, teaching skills.


Communication, organizational skills, able to work both in a team and independently.


There are courses available at various private institutes to become a Clinical Research Associate but PPD also offers internal trainee-CRA opportunities.


Networking and personal skills.


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.

Christian Stoy

Position: Senior Clinical Research Associate (CRA) Organization: PPD

Contact:

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Speakers’ profiles, Session IV



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


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.


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.


Critical thinking is very important. Networking, presentation skills, resilience and others are also

helpful in daily life.


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.


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.


If you are highly motivated, enthusiastic about clinical research and a great team player, be confident

and just start this path.

Georg Isbary

Position: Medical Therapeutic Area Lead CIT GI/GU

Organization: Roche

Contact:

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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.


I am an international MSL, this means I have the same responsibilities as an MSL but within different countries.


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.


Presentations skills and statistics.


Project management, top communication skills, flexibility, ability to travel, negotiation skills,

costumer-relationship management.


GCP/ICH, project management, presentation skills.


Networking, flexibility, accepting a lower salary, speaking several languages.


Patience, networking, avoiding a Postdoc

Antonio Garreta

Position: Global Strategic Scientific Liaison Organization: Bayer

Contact:

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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.


Study supervision and scientific engagement partner for key opinion leaders in the field of

neuroscience.


I like to interact with a team and work highly scientific to achieve a combined goal.


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.


Outgoing, flexible, scientific person who loves to travel.


Marketing or sales experience is a plus.


Being at the right spot at the right time.


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.

Philipp Kulozik

Position: Medical Scientific Liaison Manager Organization: Novartis Pharma GmbH

Contact:

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Videos



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).


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.


After many years of bench research, I wanted to go one step further and see drugs applied to

humans.


Organizational and communication skills.


Interpersonal skills and team spirit.


Yes, Clinical Monitoring Course at Mibeg, Pharmaakademie or similar.


The training at the Clinical Monitoring Course allowed me to gain the experience needed for applying

to a CRA position.

Antonino Natoli

Position: Site Management Lead Organization: IQVIA

Contact:

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Videos



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.


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


I have always enjoyed scientific writing. Working as a medical writer helped me to turn my passion

into a profession.


Data interpretation and analytical skills; Writing and presentation skills; Project and time

management; Ability to freely discuss science with experts; Teamwork


Communication skills


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.


Networking primarily through LinkedIn

Nibedita Gupta

Position: Associate Medical Writer Organization: Envision Pharma

Contact:

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Workshops


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

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.

Andreas Eisenmenger

Position: Project Manager for Clinical Trials Organization: NCT Trial Center

Contact: [email protected]

Martijn Bijker

Position: Director Organization: From SCIENCE to PHARMA Pty Ltd

Contact:

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Thank you to our Sponsors


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Thank you to our Sponsors


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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:

[email protected]

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)

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PDN Network


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.

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

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.

Career

Develop-

ment

Alumni

Network

The PostDoc Network – from PostDocs for PostDocs

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.

Get

Together

PostDoc

Retreat

Expertise

Exchange

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:

[email protected]

PostDoc

Network

PDN Committee 2018 © PDN

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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 [email protected]

• 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

• Prof. Dr. Manfred Schwab (Chairman of the Board of Alumni DKFZ)

e-mail: [email protected]

• Susanne Schunk (Management Alumni DKFZ)

e-mail: [email protected], phone: +49 (0)6221-42449

Alumni New Year's Reception 2018: "Alaturka"

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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

Postdoc

Program

Marion Gürth, Barbara Janssens, Karin Greulich-Bode Celina Cziepluch Philipp Gebhardt

Advanced

Training

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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-fakultaet-

hd.uni-heidelberg.de/Ethikkommission.106025.0.html

• NCT Clinical Trial Center https://www.nct-heidelberg.de/forschung/nct-core-services/nct-

trial-center.html

• Koordinierungszentrum für Klinische Studien (KKS) http://www.kks-netzwerk.de/

• Koordinierungszentrum für Klinische Studien Heidelberg https://www.klinikum.uni-

heidelberg.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

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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

• 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

Books

• 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

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Feedback


YOUR FEEDBACK is important to us!

Please answer your questions at:

https://www.surveymonkey.de/r/77ZXTCY

Save the Date

Deutsches Krebsforschungszentrum (DKFZ) | Im Neuenheimer Feld 280 | 69120 Heidelberg

CAREER DAY

Project Management

SEPTEMBER 28th, 2018 German Cancer Research Center

Space for a QR code

(optional)

SAVETHEDATE…

…WhenExpecta3onsMeetReality

GetInsightsfromDKFZAlumni

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Program

Clinical Research Career Day 08.06.2018- program

Session 1 9:00- 9:50

From bench to bedside: all you need to know about clinical research

1. Opening remarks Prof. Baumann, Scientific Director

2. Opening remarks Agata Bloswick, Senior Director Project Management, Covance

3. Stefan Pusch; DKFZ and Lukas Bunse; Universitätsklinikum Heidelberg

Coffee break 9:50-10:20

Session 2 10:25-11:45

Clinical Research Management

1. Aurora De Ponti; Senior Global Trial Manager, Novartis

2. Carmen Lilla; Associate Medical Director Oncology, Bristol-Myers Squibb

3. Sabine Brutlach; Clinical Project Manager, CureVac

4. Ruth Merkle; Manager Technology & Clinical Liaisons, Hummingbird Diagnostics

Lunch 11:45-12:45

Round table I 12:45-13:30 (A. De Ponti, C. Lilla, S. Brutlach, R. Merkle)

Session 3 13:30-14:30

Monitoring clinical trials

1. Christian Stoy; Senior CRA, PPD

2. Tairi Aljand; In-House CRA, PRA Health Sciences

3. Agata Bloswick; Senior Director Project Management, Covance

Coffee break & round table II 14:30-15:30 (Ch. Stoy, T. Aljand, A. Bloswick, G. Isbary)

Session 4 15:35-17:00

Medical affairs and communication in clinical research

1. Georg Isbary; Medical Therapeutic Area Lead CIT, Roche

2. Antonio Garreta; Global Strategic Medical Liaison, Bayer

3. Philipp Kulozik; Medical Scientific Liaison Manager, Novartis

4. Closing remarks

Networking & drinks- from 17:00

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Documents

[email protected]@dkfz Speakers’ profiles, Session I Page 7 Career Day “Clinical Research” June 8th, 2018 Could you briefly describe your academic path and scientific