rutgerscareeropportunities

8/2/2019 rutgerscareeropportunities

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T Pcticl Idty

Career OPPOrTunITIesOr PharmaCIsTs

o mo Iotio, Cotct:

Institute or Pharmaceutical Industry FellowshipsErnest Mario School o Pharmacy

Rutgers, The State University o New JerseyDepartment o Pharmacy Practice and AdministrationBusch Campus160 Frelinghuysen RoadPiscataway, NJ 08854-8020

[email protected]

CoclioThe career paths described are

representative o the many exciting possibilities

that await pharmacists entering todays pharmaceutical

and biopharmaceutical industries. Additional areas o concentration

include Business Intelligence, Consumer Health, Promotion Compliance,

Policy & Advocacy, R&D Strategy and Analysis, and many others.

With a career in the pharmaceutical industry, a pharmacist has an

unparalleled opportunity to make a signifcant contribution to the

development and delivery o medicines to patients around the world.

The pharmacists role in industry has evolved rom traditional areas

o sales and manuacturing, and currently encompasses a wide array

o clinical, medical, and marketing unctions. Frequently, positions

sought by pharmacists in the pharmaceutical industry require additional

postgraduate training, which can be obtained through participation in

a ellowship or residency program. Individuals interested in a career in

industry are encouraged to research and consider careully the availablepostgraduate training program options to help them make inormed

career choices with respect to the pharmaceutical industry.

pllow.tg.dInstitute for Pharmaceutical Industry Fellowships Ernest Mario School of Pharmacy

Rutgers, The State University o New Jersey, 160 Frelinghuysen Road, Piscataway, NJ 08854

For more inormation,

scan this QR code.


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Pcit d t Pcticl IdtyTodays pharmacy graduates have numerous career options. Traditionally,

pharmacists have used their clinical knowledge in a variety o practice

settings, including community pharmacies and hospitals. However, there

are also many signifcant, alternative career opportunities within the

pharmaceutical and biopharmaceutical industries. The extensive clinical

training provided by the Pharm.D. degree program has helped to expand

the pharmacists roles and responsibilities within the industry.

The pharmaceutical industry now oers a wide variety o comprehensive

experiences set in a dynamic corporate environment that allow pharmacists

to apply clinical skills in innovative and exciting ways to improve patient

healthcare. Employment in the pharmaceutical and biopharmaceutical

industries setting provides opportunities or proessional development

and growth, lateral and upward mobility, and the opportunity to display

and be recognized or ones unique proessional expertise. Opportunities

to collaborate with experts in multidisciplinary project teams urther

enhance the value and scope o the pharmacists role. With advances in

medical technology, the pharmaceutical and biopharmaceutical industriesare constantly expanding eorts to discover, develop, and market

new medicines, thereby creating more employment opportunities or

pharmacists. This brochure provides inormation regarding some o todays

popular industry career paths or pharmacists.

ely P Cliicl Dvlopt

Early Phase Clinical Development encompasses

research rom pre-clinical studies through phase I-IItrials o the drug development process. These trialsare the frst time an exploratory compound is studiedin a human population and are commonly known as

frst in human trials. As a clinical research scientist,pharmacists assume lead roles in

Implementingandmanagingclinicaltrials Authoringstudyprotocols Selectingprimaryinvestigatorsandtrialsites Ensuringproperdatacollectionandinterpretation

Determiningthebestdoseofthemedicationforlater studies

Reportingseriousadverseevents Publishingclinicalstudyreportsandmanuscripts

As leaders o multidisciplinary teams, pharmacists inEarly Phase Clinical Development liaise closely withvarious other departments, such as 1) RegulatoryAairs, 2) Data Management, 3) Drug Supply

Management, 4) external contractors, and 5) Pre-clinicalSaety Scientists.

With broad clinical backgrounds and knowledge o thedrug development process, Pharm.D. graduates are

well suited or Clinical Development. Opportunitiesin Early Phase Clinical Development exist in ClinicalPharmacology,Translational Medicine,

Clinical Operations,

and ContractClinical ResearchOrganizations.

Lt P Cliicl Dvlopt

Late Phase Clinical Development encompa

research rom phase II and III human trials development process. A pharmacist acting trial leader in Late Phase Development expmany o the same challenges acing those

Phase Development, however, on a much bmore global scale.

Pharm.D.s are well suited to assume a rolePhase Development as they have an exten

o knowledge in

Pharmaceuticalproductutilization

Treatmentmodalities Pharmacokinetic/dynamicrelationships Drug-druginteractions

The aorementioned skills enable pharmaccontribute to the development and implemcomplex study designs that are typically restage o drug development.

Pharm.D.s in Late Phase Development haveopportunity to showcase their skills by

Planninginvestigatormeetings Chairinginternationalclinicaltrialteam Overseeingdeliverablesfromvariousex

contractors

Combined with a strong scienbackground, key skills necess

career in Late Phase Clinical include excellent organizatiocommunication,and presentation

abilities.

An Interview With: Justin Dennie Pharm.D. Merck Fellow 2009-11Q: What attracted you to Clinical Pharmacology

for your fellowship and as a prospective career

choice?

A: Throughout my pharmacy school curriculum,

the two classes that represented the core opharmacy to me were pharmacokinetics and

pharmacology, areas which I ound the most

intriguing and where my passion lay. Clinical

pharmacology was a natural t or my interests,

in that determining the true pharmacologic andpharmacokinetic prole o a drug in humans are

the major objectives in clinical pharmacology

studies. These studies include rst in human

studies, QTc studies, renal studies, hepaticstudies, microdosing studies, just to name a

ew, but all contain undamental principles in

pharmacology and pharmacokinetics.

Q: How does having a Pharm.D. help you to

excel in your current position?

A: Pharmacists are very well poised or a

rewarding and impactul career in clinical

pharmacology, and throughout R&D or thatmatter. Pharmacists are trained in most o the

undamental principles in drug development

(pharmacology, pharmacokinetics, medicinal

chemistry etc.). We possess the communication

and interpersonal skill set necessary toeectively and eciently lead project teams.

We help steer candidate compounds through

Phase I studies to eventual product launch.

Pharmacists are trained as generalists and ourskills can truly be applied to all aspects o R&D,

not just to Phase I drug development.

Q: What advice can you give to someone

seeking a fellowship or career in clinical

pharmacology?

A: To excel in clinical

pharmacology,

it is important

to rely on onesclinical pharmacy training and

new ideas and principles. I ref

my rst departmental meeting

were presented with the curre

pipeline. I had recently taken tthought I was an expert on an

pharmacology related. I camerealization that this was not th

could only recognize a handu

drug targets or mechanisms othe companys entire preclinic

pipeline. This conrmed the n

pharmaceutical industry is at

o medicine and drug develop

to be successul, I would haveo continuous learning and se


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An Interview With: Jerald Grace, Pharm.D. Roche 2nd Year FellowQ: What attracted you to Regulatory Affairs

for your fellowship and as a prospective

career choice?

A: Drug development has always been an

interest o mine. During my last year opharmacy school, I had the opportunity to do an

industry rotation in Regulatory Aairs, where

I developed labeling assessments, sat in on

cross-unctional team meetings and deliveredpresentations on current FDA hot-topic issues.I enjoyed working with other disciplines and

staying abreast o the ever-changing regulatory

environment. This experience is what

interested me to pursue Regulatory Aairs as a

career post-graduation.

Q: What has been the stand out moment so

far for you in your fellowship?

A: My standout moment in my ellowship

was when I helped my team le a New Drug

Application (NDA) with the FDA. Duringthe process, I was able to sit in on team

discussions where nal decisions were made

or the drugs trade name, proposed labeling

language and specic submission timelines.I even assisted with developing some o thedocuments that would go into our submission.

I was able to witness rsthand the amount

o time, dedication, and teamwork it takes to

actually get a new drug on the market. The

experience was phenomenal.

Q: What advice can

you give to someone

seeking a fellowship

or career in

Regulatory Affairs?

A: Take ull advantage o all op

may be presented with. Regula

oers you the potential or a va

assignments that will develop expertise within the departmenYou never know where your pr

experiences will take you.

mdicl Coictio/edctio/Iotio

PharmacistsintheMedicalCommunications/Education/

Inormation department utilize their clinical knowledgein the development o content or healthcare-relatedpublications, meetings, and digital media or an arrayo audiences, including healthcare proessionals and

consumers. In this role, pharmacists

Criticallyanalyzeandevaluateevidence-based

medicine Planandimplementcontinuingeducationprograms

and materials Collaborateandnetworkwithkeyopinionleaders

(KOLs) rom industry, managed care, and academiato create promotional and educational programs Manageclientexpectationswhileeffectively

integrating key messages into programs orhealthcare proessionals

Actasakeymemberinthedevelopmentof

publication plans Respondtoexternalinquiriesfrompatientsand/or

healthcare proessionals Createandmanagequestion-responsedatabases

or marketed products

In addition, a Pharm.D. in the feld o Medical

Communications can also be involved in confrmingthe accuracy and scientifc quality o abstracts, postersand oral presentations o high level clinical data orpresentation at various conerences and congressesboth nationally and internationally.

In this role, a Pharm.D. works closely with 1) BrandMedical Directors, 2) Clinical Development teams,3) Biostatistics, 4) Product Strategy teams, 5) Marketing,6)Legal/Compliance,and7)FieldMedicalteams.

Dg rgltoy ai

Drug Regulatory Aairs is the proessiona

consisting o the knowledge o the regulatiguidelines, policies, and precedents governdiscovery, development, manuacturing, gapproval, commercial distribution, advertis

promotion o medicinal products. Pharm.Din Drug Regulatory Aairs (DRA) have the oto participate in large US and global cross-project teams in nearly all aspects o the ddevelopment process. DRA associates are a

the progress o a product and gather key leHealth Authority interactions to guide the p

on how to fle and conduct trials or a drugregister a product and gain approval. A phaRegulatory Aairs may

DevelopandprovideRegulatorystrategy CreateandcompilesubmissionstoHeal

Authorities including Investigational NewApplications and New Drug Application

InteractwithFDA(Food&DrugAdminisGlobal Health Authorities such as the EM

and MHW (Japan) LeadHealthAuthorityCommunications

FDA Meetings and Advisory Committee Developandreviselabeling Reviewandapproveadvertisingandpro

material MaintainapprovedproductsthroughIND

Annual Reports, DDMAC submissions, l

line extensionsA position in Regulatory Aairs provides exdrug development activities and a unique outilize ones clinical pharmacy skills.

Cocil ctio, Icldig mktig

The Marketing department is responsible or strategic and tactical implementation o the advertising and

promotion supporting a companys products. The overall goal o marketing is to develop programs that drivehealthcare providers awareness o products and promote optimal medication utilization. Tactics includepromotional activities, such as

Creatingsalesmaterialsandproductadvertising Organizingandcreatingcontinuingmedicaleducationorconsultantpanels

TheMarketingResearch/BusinessAnalyticsdepartmentisalsoanimportantgroupwithinthecommercialteam.This department acquires inormation rom various sources outside o the company to create an overall marketsnapshot. With this inormation, Business Analytics supports Marketing in developing a clear and targeted

messagetoappropriatephysicians,patients,andthirdpartypayors.APharm.D.inMarketResearch/BusinessAnalytics generally helps to:

Analyzepastandpresentmarketdatatomonitorcurrentandfuturetrends Forecastmarkettrends Createpatientpopulationevaluationmodels Identifyunmetmedicalneeds

Pharmacists also make strong team members in the Managed Markets group. While working in ManagedMarkets, a Pharm.D. helps to develop strategies to optimize reimbursement rom third-party payors or insurancecompanies. The Managed Markets group works to promote optimal medication use and enhance product market

share versus competition. In addition, Managed Markets also works to improve overall resource management,the companys pipeline o products in development, and overall healthcare quality.

An Interview With: Hiliary Johnson, Pharm.D. Sanof Fellow 2009-11Q: What attracted you to Marketing for your

fellowship and as a prospective career choice?

A: I selected a Marketing Fellowship because

I wanted an experience where I could utilize

my strong clinical background, while gaininginsights into the business side o the industry.

I enjoy being challenged, and getting to use

my creativity to solve problems and generate

innovative ideas. Its rewarding to know thatby working in pharmaceutical marketing Iam benetting patients around the world by

enhancing awareness and helping to nd

solutions to the expanding problem o diabetes

and the treatment and management options that

are available to help control it.

Q: How does having a Pharm.D.. help you t o


A: The Strategic Marketing Fellowship has

provided me with a unique opportunity to apply

my clinical knowledge within the commercial

unctions o the pharmaceutical industry. My

pharmacy background and rotational experiencesgive me an advantage in that I understand not

only the drugs, but the target customer and their

needs, whether they be healthcare providers,

hospitals, pharmacies or patients.

Q: What has been the stand out moment so

far for you in your fellowship?

A: I recently witnessed the successul

outcome o two live speaker training meetings

I put together or 250 key thought leaders

in a diabetes speakers bureau. This was

the culmination o months o hard work andinteraction with multi-disciplinary teams

including medical,

legal, and regulatory,

as well as with

outside vendors,

key thought leaders,and the sales orce. I was able to implement

an exciting, new acilitators training workshop

into the meeting that resonated very well with

attendees. This was a unique opportunity or aellow, and one that strengthened my teamwork

and leadership skills. It was also very important

to the business as we work to re-engage key

thought leaders and increase our share o voice

in the diabetes market.


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Dg sty d rik mgt

Throughout the development liecycle o apharmaceutical product, the Drug Saety Departmentassumes responsibility or ensuring that a productwill be marketed and used in a sae and eective

manner. Pharm.D. graduates have ound a niche in thisdepartment by

Evaluatingaproductssafetyprolethroughoutitsdevelopment and into its post-marketing stage

Participatinginclinicaldevelopmentteamdiscussions relating to adverse events

Integratinginformationfrompre-clinicalsafetytrials

to ongoing trials Contributingtoongoingsafetydocumentssubmitted to health authorities Periodi c Saety Reports (post-marketing) Annual Saety Report (submitted to the EMA)

IND Annual Report (FDA equivalent to the abovereport)

REMS (Risk Evalution and Mitigation Strategy)and RMP (Risk Management Plan)

In this role, pharmacists have the ability to projecttheir broad knowledge o pharmaceutical products

onto study fndings and to help guide compounddevelopment. With the keen eye o a pharmacist, vitaldecisions, such as determining a drugs maximallytolerated dose or appropriate populations to be studied,can be made in a sae and objective manner.

hlt ecooic d Otco r

The Health Economics and Outcomes Rese(HEOR) group helps to identiy, measure, acompare the costs and consequences o hecourses o action to assign a perceived v

pharmaceutical intervention. The value prointegral to determining the price o pharmproducts. A lengthy analysis is perormed bany conclusions are reached, and it is durindata analysis that a Pharm.D. can make a s

contribution. Pharmacists are no stranger teconomic data, and can assist in the analysproducts

Prospectiveandretrospectiveclinicalda Competitivepricing(RedBook-USA,Dru Qualityoflife(QOL)andquality-adjusted

(QALYs) data

Once these important data are reviewed, a HEOR can create tools to help guide a prod

This analysis can be used by many agencie

Comparetheeconomiceffectoftwoor

drug products Assistinthedevelopmentofdrugformu Developnationalorinternationalclinica

guidelines

mdicl scic Liio

Medical Science Liaisons (MSLs) are therapeuticspecialists who coordinate the communication oclinical inormation between pharmaceutical companiesand medical experts in the feld. An advanced degree

(eg, MD, PhD, or Pharm.D.) is usually required to obtaina position as an MSL. The majority o MSLs hold aPharm.D. degree. Depending on the company, the MSLcan have many dierent titles (e.g., medical sciencemanagers, medical inormation scientists, regional

scientifc managers).

The MSL is a feld-based associate who collaborates

with and communicates inormation to

Thesalesforce Practitionersintheeld Clinicaltrialinvestigators

InternalstakeholdersManagedMarketsteams

Generally, the MSL reports to the medical department.Specifc unctions o the MSL include developing andcultivating relationships with experts, training speakersand the sales orce, providing medical inormationsupport, and developing educational programs.

Overall a pharmacist is well suited or a career asan MSL, as it requires one to be able to clearly andeectively communicate an extensive amount o clinical

knowledge to other healthcare proessionals. MSLsare also expected to build relationships with many

individuals in the healthcare feld, as they are oten seenas the ace o the company out in the feld. Pharm.D.sbring an extensive range o scientifc knowledge to

the MSL position, including their ability to learn andunderstand aspects o various therapeutic areas.

mdicl d scitifc ai

Pharmacists in the Medical and Scientifc Aairsdepartment develop and coordinate the implementationo medically accurate and credible medical educationprograms and serve as scientifc resources to

communicate product inormation to externalcustomers via various promotional and educationalprograms. A Pharm.D. in Medical and Scientifc Aairs

Providesexpertiseongloballifecyclemanagement CollaborateswithGlobalBrandMedicalDirectors

and their teams Integratesdatafrominternalandexternalsources

into actionable inormation or clients Reviewsandapprovespromotionandadvertisingrom a medical perspective in compliance with FDAregulations

At certain companies, Pharm.D.s in Medical Aairs alsohave the opportunity to develop and manage Phase IVtrials, know as post-marketing studies. These trials

include

Post-marketingsafetyorpharmacovigilancestudies

InvestigatorSponsoredStudies(ISS) Expandedlabelstudies Alternatedosingorschedulingstudies Uniquepatientpopulationstudies

Pharmacists extensive understanding o drug productsprepares them to identiy and understand a products

potential impact in the real world as opposed to whatwas seen previously in controlled trials.

Elaine Alexander, Pharm.D. Bayer 2nd Year FellowQ: What attracted you to Medical Affairs for

your fellowship and as a prospective career

choice?

A: I selected a Medical Aairs Fellowship

because I knew it would allow me to apply

my clinical knowledge and strengthen my

communication skills, while developing

business acumen to be successul in thepharmaceutical industry. Medical Aairs

is such a large umbrella which hasallowed me to work cross-unctionally

with many departments (including medical

communications, drug saety, healtheconomics, and the medical science liaison

team) and truly identiy my proessional

interests.

Q: How does having a Pharm.D. help you to


A: Having a PharmD sets the initial oundation

o clinical knowledge, proessionalism, and

strong work ethic that are necessary to excelin the pharmaceutical industry. I interact with

a team o proessionals who value my ability t o

critically evaluate scientic data and medical

literature, as well as to speak on a clinical level.These are skills that are transerrable rom the

classroom to the corporate environment o the

pharmacy world.

Q: How has the fellowship changed not only

your professional but also your personal life?

A: Now more than ever, I believe in the power

o proessional networking. The Fellowshipprogram has brought me together with so many

incredible and inspiring individuals, many o

whom I may never have crossed paths with

otherwise. Ive established a proessional

network with colleagues and have identied

several mentors

who will continue

to support methroughout my career. Ive applied the same

networking skills to my personal lie and have

made lie-long riends and memories with

many ellows.

Q: What advice can you give to someone

seeking a fellowship or career in Medical

Affairs?

A: Seek opportunities and dont be araid to try

new things. There is no limit to your growth

potential! Volunteer to get involved in an

interesting project or take the time to rotate withanother department. You may discover talents

and passions that you never knew you had.

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