Career opportunities for Ph.D. s in the pharmaceutical industry. Martin C. Michel, MD, MAE, FBPharmacolS

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1 Career opportunities for Ph.D. s in the pharmaceutical industry Martin C. Michel, MD, MAE, FBPharmacolS

2 Disclaimer This presentation is intended to inform about career opportunities in the pharmaceutical industry in general; it is not intended to promote Boehringer Ingelheim as an employer. The job profiles and processes described here are based on those used by Boehringer Ingelheim. Other companies are likely to have similar job profiles and hiring processes, but may have different names for some of the functions described here.

3 Boehringer Ingelheim in brief Boehringer Ingelheim Center Our headquarters in Ingelheim, Germany Family-owned global corporation Founded 1885 in Ingelheim, Germany Focus on Human Pharmaceuticals, Animal Health and Biopharmaceuticals Total net sales: 14,065 million in 2013 Employees worldwide more than 47,000 R&D worldwide at five sites Expenses for R&D: 2,743 million (19.5% of revenue) 16 production facilities in 11 countries Affiliated companies: 142 worldwide Investment in tangible assets: 558 million 3

4 Who is Boehringer Ingelheim? Main areas of interest: Airway diseases Cardiometabolic diseases Oncology CNS diseases Immunology & Infectious diseases

5 Congratulations on your Ph.D.!

6 What s next? The ugly fact: In a system without net growth, by average each professor can only bring one of his/her trainees to reach the same career level but has more trainees than that Where do all the others go? The vast majority of PhD s will have to find long-term positions outside academia

7 Key messages Working in industry is not plan B Identify the career option that fits you, and then design your next steps to qualify in that direction

8 Aim of this presentation To create awareness of the multitude of career opportunities in the pharmaceutical industry and advice on how to get there Career opportunities also exist with other types of non-academic employers but are not covered here

9 Job characteristics: academia vs. industry Academia Self-driven, but do not underestimate institution/funder preferences High degree of independence and selfdetermination Often very specialized asdfadfasfd adsfa adsf Working in teams advantageous asdf asdf Limited vertical and even less horizontal career options Need to obtain external funding asdfa asdfa Reliable but moderate potential for salary development Job security? Industry Goal-driven, but do not underestimate own influence on goals Less independence and selfdetermination, but not by much Often generalist, specifically in higher functions Working in interdisciplinary teams a must More vertical and horizontal career options No need to obtain external funding, but internal funding also competitive Greater potential for salary development asf Job security?

10 Some of the many career options in industry Research & Development (Medicine & Medical Affairs) Pharmacovigilance Clinical Operations Production Operations Quality Assurance Drug Regulatory Affairs Licensing Publications management Medical Science Liaison Marketing & Sales Market Access and many others some not as entry level but via cross-functional moves within a company

11 Jobs in Research & Development Large segment of academic jobs in industry Target identification Drug discovery Lead optimization Formulations Pharmacokinetics Postdoc experience typically required Initial hiring often based upon highly specialized skills Often starting point to move to other functions

12 Jobs in Medicine & Medical Affairs Can have roles in clinical development or for marketed drugs Clinical development: design, analyze and report clinical phase I-III studies Marketed drugs: phase IV studies; handle internal and external medical information requests Postdoc experience typically required Medical background preferred, but PhD with general medical knowledge possible Clear orientation on applied research a plus for non-medical applicants

13 Jobs in Pharmacovigilance Establish and maintain database on safety and tolerability of drugs Analyzing adverse event pattern in clinical trials and spontaneous reports Generating reports for regulatory authorities on a regular basis Highly formalized processes, great attention to details required for patient safety Postdoc experience typically required If no medical background, at least general medical knowledge required Often as move within company

14 Jobs in Operations (clinical trial monitoring) Operations covers a wide range of functions Clinical trial organization and monitoring are important examples Formalized processes based on ICH and GCP guidelines Possibly heavy local/regional travel activity (site monitoring) Postdoc experience beneficial but not required If no medical background, at least general medical knowledge required

15 Jobs in Operations (Chemical and Pharmaceutical Production) Operations covers a wide range of functions Large scale synthesis of Active Pharmaceutical Ingredient (API) Improvement of route of synthesis Pharmaceutical manufacturing of the finished product Lifecycle management/improvement of existing formulations Quality control and quality assurance Supply of clinical trials with finished products Project management of cross functional activities Site monitoring of external partners, possibly heavy local/regional travel activity Formalized processes based on ICH and GMP guidelines Background in chemistry, pharmacy, chemical engineering etc. very often expected Postdoc experience beneficial but not required General medical knowledge beneficial

16 Jobs in Quality Assurance (QA) Monitor pharmaceutical quality of drug substance and drug product production and packaging process as well as analytics for starting materials, excipients, APIs, bulk and drug product Monitor and evaluate the validity of the different manufacturing steps as well as methods used Release of documentation like master batch records, testing specifications, stability programs, validation plans, Support during inspection and audits Postdoc experience typically required as chemist, pharmacist, technologist Background in analytical techniques beneficial as well as knowledge regarding registration and manufacturing cgmp, ICH guidelines, AMG, AMWHV. Knowledge

17 Jobs in Drug Regulatory Affairs Management of all regulatory aspects of pharmaceutical products throughout product lifecycle Development, implementation and adjustment of regulatory strategies during the development phases of the drug product lifecycle in accordance with current regulations and guidance Interaction with regulatory authorities for initial approval of new drugs and maintenance of existing registrations Coordination with preclinical, clinical, medical affairs manufacturing and quality systems groups Safeguarding of accuracy and quality of regulatory submissions Safeguarding of regulatory compliance to drug product label requirements Highly formalized processes Postdoc experience typically required, understanding of legal processes beneficial Often as move within company

18 Jobs in Licensing Networking with potential partners in industry, small companies and academia Coordination of scientific and commercial evaluation of opportunities for in- and out-licensing Handling of projects covering a broad range of indications within one or more therapeutic areas University degree, good general knowledge in life sciences preferably e.g. in biochemistry, biology, chemistry, medicine, pharmacology Understanding and knowledge of drug development and relevant patent, legal and commercial implications Analytical skills, business oriented, MBA of advantage Postdoc experience, in particular 3-5 years of industry practice or similar desired Often as move within company

19 Jobs in Publication Management Plan the publication strategy for a drug in close interaction with Medical Affairs, Clinical Development, Project Management, Statistics and other functions involved in the development of publications Timely execution of the publication plan by leading individual teams responsible for the delivery of a publication Interactions with external authors and medical writers Experience in clinical development, pharmaceutical industry and/or medical writing/publication management typically required Capability of strategic thinking as well as good project management skills are a plus Often as move within company or from external medical writing agency

20 Jobs as Medical Science Liaison Establishes and provides scientific expertise to support a region with product and disease state knowledge through individual and group presentations of scientific information Identifies and interacts with external experts through credible and accurate medical/scientific exchanges of information Contributes to continuous knowledge development of brand, competitors, disease state, and overall therapeutic knowledge Attends/participates in scientific congresses/meetings in Europe/Overseas in support of brand/entities No direct promotional activity! Typically a field-based function (up to 60% travel time) At least 2 years of medical and/or field experience in pharmaceutical industry Excellent communication and inter-personal skills Often as move within company

21 Jobs in Marketing & Sales Analyzing market potential, competitive environment, customers and stakeholders needs Creating and executing marketing and promotional strategy including forecasts and budgets Organizing sales force Sales representative can be an entry level function Postdoc experience not required Interest or even formal training in business function more relevant Often trainee function as entry level

22 Jobs in Market Access Analyze environment for market access in a given country and globally Includes Health Economics & Outcome Research Establish and implement strategies for market access and reimbursement Prepare value dossier demonstrating clinical and economic effectiveness of (new) products Can be MD, PhD, health economics or MBA background Interest or even formal training in business function more relevant Often trainee function as entry level (postdoc not required) Degree in Health Economics or relevant experience required to work in Health Economics & Outcomes Research Industry or consultancy experience required for other market access functions on global level Market access experts highly demanded in industry

23 What does this mean in practical steps? A post-doc period of a few years is a good way to broaden experience and deepen knowledge, even if you plan to work in a company later on Start thinking about where you wish to be 5 years down the road about 1 year prior to graduation or desired entry date Make specific plans about 6 months prior to graduation or desired entry date

24 Applying for a job Job requirements Most entry level positions for PhD s require post-doc experience Exceptions are jobs in Market Access and Marketing & Sales which often offer trainee programs Application process Open solicitations, i.e. independent of advertised job opportunities, are not promising For advertised jobs, apply to those which indeed match your qualification, experience and interest Few targeted applications are more promising (and less frustrating) than many untargeted applications Informal inquiries via an internal contact in the target company can be helpful

25 A piece of personal advice The University of Duisburg-Essen (similar to some others) offers an MSc program in Pharmaceutical Medicine 2 year program with national and international accreditation Targeted at junior company employees and those wishing to find a job in industry Largely self-study with 1 weekend per month face time Covering entire value chain from target discovery to marketing Taught by practitioners in the field from 18 different companies and regulatory authorities (BfArM) >90% of graduates within 1 year got a promotion or found a job in industry Application is open for the next program starting April 2015 at

26 Good luck!

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