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Martin C. Michel, MD, MAE, FBPharmacolS

Career opportunities for Ph.D.‘sin the pharmaceutical industry

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.

Boehringer Ingelheim in brief

• 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

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Boehringer Ingelheim Center Our headquarters in Ingelheim, Germany

Who is Boehringer Ingelheim?

Main areas of interest:• Airway diseases• Cardiometabolic diseases• Oncology• CNS diseases• Immunology & Infectious diseases

Congratulations on your Ph.D.!

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

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

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

Job characteristics: academia vs. industry

Academia• Self-driven, but do not underestimate

institution/funder preferences

• High degree of independence and self-determination

• Often very specialized asdfadfasfd adsfaadsf

• Working in teams advantageous asdfasdf

• Limited vertical and even less horizontal career options

• Need to obtain external funding asdfaasdfa

• Reliable but moderate potential for salary development

• Job security?

Industry• Goal-driven, but do not underestimate

own influence on goals

• Less independence and self-determination, 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?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

www.pme-institute.com

Good luck!