Pharma Careers 101

An overview

Presented by:

Janice Albert, MSc. Pharmacology

PhD Candidate, Experimental Surgery

Sharing my experience

Education:

MSc Pharmacology (1993)

PhD candidate, Experimental Surgery (since 2010)

Pharma experience: Hoechst-Roussel (1993-1996) Hoechst Marion Roussel (1996-1999) Schering Canada (1999-2002) Merck-Schering Pharmaceuticals (2002-2005) Schering-Plough Canada (2005-2010)

Presentation Outline

1. Typical Medical Department

2. Positions for MSc, PhD and MDs

3. Tips – Job Interview

4. The 1st 100 days

Canadian Studies

InternationalStudies

Headquarter Studies

Source: adapted from FDA website

Clinical Trial – Phase III

Post-Marketing – Phase IV

Clinical Trial – Phase II

Clinical Trial – Phase I

Pre-Clinical - animals

Drug Development Process

Drug approved by Health Canada

1 2

3

45

67

Source: Google images

Typical Medical Department

VP Medical

Clinical Research(Phase III)

Medical Affairs

(Phase IV)

Regulatory Affairs

Compliance

Drug Safety

Medical Information

Other notations: Clinical Operations, ** Health Outcomes, Scientific Affairs

Extended Team Members

VP Medical

Clinical Research

Medical Affairs

Regulatory Affairs

Compliance

Drug Safety

Medical Information

Sales DepartmentMarketing

Department

Government Affairs

Legal Department

Manufacturing Department

Finance Department

Clinical Research Organization (CRO)

Office of the President

Clinical Research Associate (CRA)

Project Manager (PM)

Home-based Office-based

60% - 70% travel 10%-20% travel

Manages 10-15 study sitesin a given region

Manages all study sites

Visit study sites every 6-8 weeks (monitoring)

Visit study sites prior start-up (pre-study)

Write visit reports Review visit reports

Positions in Clinical Research

Clinical Research Associate (CRA)

Project Manager (PM)

Works mainly with nurses, doctors and pharmacists

and various PMs

Works mainly with people at head-office and in the US

and team of CRAs

No budget responsibility Plan budget for Canada

Review study documents at the site after start-up

Review study documents prior release to sites

Positions in Clinical Research

CRA relies on PM

PM relies on CRA

Skills – CRA and PM

Verbal and written communication

Attention to details

Organized

Interpersonal skills

Problem solving skills

Multi-tasking

NegotiationConflict

resolution

Science background

Association of Clinical Research

Professional (ACRP)

www.acrpnet.org

Can be learned!

Tips !

• CRA position is the fastest way to get your foot in the door

• It takes 3 years to master the position

• Best way to be successful as a future PM

Source: Google images

So many things….so little time

Source: Google images

Did I miss something?

Source: Google images

Medical Science Liaisons (MSLs)

Scientific Director and/or Medical Advisor

Home-based Office-based

60% - 70% travel 30%-40% travel

Manages 15-20 doctors in a given region

Manages all doctors using the BRAND (marketed drug)

Works with TOP doctors (Key Opinion Leaders)

Works mainly with people at head-office and in the US and

team of MSLs

Write visit reports Review visit reports

Positions in Medical Affairs

Medical Science Liaisons (MSLs)

Scientific Director and/or Medical Advisor

Execute Medical Affairs Plan Prepare Medical Affairs Plan to support the BRAND

What is a Med. Affairs plan?

KOL development Publication strategy Scientific Conferences Study Grants for Doctors

Slide kit preparation Training (Internal/External) Advisory Boards Detailed budget

Positions in Medical Affairs

MSL relies on

Director

Director relies on

MSL

Skills – MSL and Scientific Director

Verbal and written communication

Attention to details

Organized

Interpersonal skills

Problem solving skills

Multi-tasking

NegotiationConflict

resolution

Science background

Can be learned!

Business Skills

MUST HAVE

Tips !

• MSL position is more popular than ever

• Learning the pharma and the business is a challenge

• It takes 3 years to master the position

• Best way to be successful as a future Medical Advisor or Scientific Director

Regulatory Affairs Associate/Specialist/Manager

Office-based. No travel or 10%

Review and submit documents to Health Canada

IND (Investigational New Drug) application Study protocols & informed consent Product monographs (marketed drugs) Investigator’s Brochure (study drugs) Drug package inserts Changes to the chemistry and manufacturing (CMC) Drug Safety reports (quarterly, annually)

Works mainly with people at head-office and in the US

Positions in Regulatory Affairs

Attention to detailsMUST HAVE

Source: Google images

Drug Safety Specialist

Office-based. No travel or 10%.

Reviews, assess and enter adverse events in Drug Surveillance database

Works mainly with people at head-office

Contact study sites – f/u on Adverse Events

Train new employees on Adverse Event reporting

Positions in Drug Safety

Attention to details

MUST HAVE

Source: Google images

Medical Information Specialist/ Manager

Office-based. No travel or 10%

Answers drug-related questions from Doctors, nurses, pharmacists Patients Sales team

Track medical questions in Drug Information database

Works mainly with customers and people at head-office

Provide training on drug and disease

Positions in Medical Information

Communication Skills

MUST HAVE

Identify potential adverse events for Drug Safety

Job Interview

Job Interview - Tips

PREPARE

1. Read company website for news

2. Read shareholder section for R&D pipeline

3. Search clinical trials on www.clinicaltrials.gov

4. Go on www.linkedIn.com for profile

PREPARE

5. Match your CV with job description

6. Find interview questions & answers online

7. Practice your answers in front of mirror

8. Dress corporate: business suit

Job Interview - Tips

PREPARE

9. Questions about the job description

10. Training period

11. Mentorship programs / Go-to persons

12. Job’s expectations (replacement or new position?)

Job Interview - Tips

****INTERVIEW SESSION*****

1. Good handshake, good eye contact

2. Prepare your opening statement

3. Beware of non-verbal habits (body language)

4. Don’t be afraid to say “I don’t know” but give a positive spin to your answer

Job Interview - Tips

Not the right time….

Opportunity to move-up in the company (your are not hired yet)

Keep HR topics for HR (salary raise, bonus, vacations, car allowance, etc…)

Negotiate after you have an offer

Job Interview - Tips

Job Interview - Tips

AFTER the interview

Conclude with positive feedback (prepare your conclusion statement)

Send thank you note and express your interest for the job

Don’t expect an answer within 1 week

Continue to look for a job (it gives you an edge)

The 1st 100 days

*****OBSERVE, OBSERVE, OBSERVE*****

Treat people the way you want to be treated

Be positive about your job and the company

Observe group dynamics (during lunch time, meetings, off-line, when the boss speaks)

Introduce yourself to people

The 1st 100 days

*****OBSERVE, OBSERVE, OBSERVE*****

Ask for help (everyone loves to help)

Ask questions (you can’t know everything)

Make sure your boss looks good (no matter what)

Under promise and over deliver

The 1st 100 days

QUESTIONS?

Clinical TrialsTYPE # of people Endpoint Location

Phase I 20-80 Safety Dosage Range Side Effects

Mainly International

Studies

Phase II 100-300 Test Efficacy Side Effects

Phase III 1,000-3,000 Confirm Efficacy Monitor Side Effects Compare treatments

Phase IV

Surveillance study

As needed

Health Authority

Expand drug labelling

Drug's Risks and BenefitsMainly

Canadian Studies

Special Access Program (SAP)

As needed Serious or life-threatening conditions Unapproved drugs

Source: clinicaltrials.gov

Patient was dizzy and SOB @10:00am.O2 sats 92%. O2 @ 10:15 and back to 98%. Blood wk @10:30. RBC = 12. MD called.Adverse Event

Start DateDD/MMM/YYYY

End DateDD/MMM/YYYY

Severity(Mild to Severe)

Serious / Not-serious

Dizzy 26APR2011

26APR2011

? ?

Medical Chart: Patient ID 001-2346

Case Report Forms (CRF): Patient ID 001-2346

CRA – Monitoring Visit