Transcript Assessment of long-term consequences of mild to moderate

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
Drug Development Process
Post-Marketing – Phase IV
Canadian
Studies
Drug approved by
Health Canada
Clinical Trial – Phase III
International
Studies
Clinical Trial – Phase II
Clinical Trial – Phase I
Headquarter
Studies
Pre-Clinical - animals
Source: adapted from FDA website
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Source: Google images
Typical Medical Department
Clinical
Research
(Phase III)
Regulatory
Affairs
VP
Medical
Medical
Affairs
(Phase IV)
Medical
Information
Compliance
Drug Safety
Other notations: Clinical Operations, ** Health Outcomes, Scientific Affairs
Extended Team Members
Clinical Research
Organization (CRO)
Regulatory
Affairs
Clinical
Research
Government Affairs
Medical
Affairs
VP
Medical
Medical
Information
Compliance
Drug
Safety
Manufacturing
Department
Finance Department
Legal Department
Office of the
President
Marketing
Department
Sales Department
Positions in Clinical Research
Clinical Research Associate
(CRA)
Home-based
Project Manager
(PM)
Office-based
60% - 70% travel
10%-20% travel
Manages 10-15 study sites
in a given region
Visit study sites every 6-8
weeks (monitoring)
Write visit reports
Manages all study sites
Visit study sites prior
start-up (pre-study)
Review visit reports
Positions in Clinical Research
Clinical Research Associate
Project Manager
(CRA)
(PM)
Works mainly with nurses, Works mainly with people at
doctors and pharmacists
head-office and in the US
and various PMs
and team of CRAs
No budget responsibility
Plan budget for Canada
Review study documents at
the site after start-up
CRA relies
on PM
Review study documents
prior release to sites
PM relies
on CRA
Skills – CRA and PM
Interpersonal
skills
Organized
Verbal and written
communication
Multitasking
Conflict
resolution
Problem solving
skills
Negotiation
Association of
Clinical Research
Professional
(ACRP)
www.acrpnet.org
Attention to
details
Science
background
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
So many things….so little time
Source: Google images
Did I miss
something?
Source: Google images
Source: Google images
Positions in Medical Affairs
Medical Science Liaisons
(MSLs)
Home-based
Scientific Director
and/or Medical Advisor
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
Scientific Director
(MSLs)
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
MSL relies
on
Director
 Slide kit preparation
 Training (Internal/External)
 Advisory Boards
 Detailed budget
Director
relies on
MSL
Skills – MSL and Scientific Director
Interpersonal
skills
Science
background
MUST HAVE
Organized
Verbal and written
communication
Multitasking
Conflict
resolution
Problem solving
skills
Negotiation
Attention to
details
Business Skills
Can be
learned!
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
Positions in Regulatory Affairs
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
Attention to details
MUST HAVE
Source: Google images
Positions in Drug Safety
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
Attention to
details
MUST HAVE
Source: Google images
Positions in Medical Information
Medical Information Specialist/ Manager
Office-based. No travel or 10%
Answers drug-related questions from
 Doctors, nurses, pharmacists
Identify potential adverse
 Patients
events for Drug Safety
 Sales team
Track medical questions in Drug Information database
Works mainly with customers and people at head-office
Provide training on drug and disease
Communication
Skills
MUST HAVE
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
Job Interview - Tips
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
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 Trials
TYPE
# of people
Endpoint
 Safety
 Dosage Range
 Side Effects
Phase I
20-80
Phase II
100-300
Phase III
1,000-3,000
 Confirm Efficacy
 Monitor Side Effects
 Compare treatments
Phase IV
As needed
 Expand drug labelling
Surveillance
study
Special Access
Program (SAP)
Location
Mainly
International
Studies
 Test Efficacy
 Side Effects
Health Authority  Drug's Risks and Benefits
As needed
Mainly
Canadian
Studies
 Serious or life-threatening
conditions
 Unapproved drugs
Source: clinicaltrials.gov
CRA – Monitoring Visit
Medical Chart: Patient ID 001-2346
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.
Case Report Forms (CRF): Patient ID 001-2346
Adverse Start Date
End Date
Severity
Event
DD/MMM/YYYY DD/MMM/YYYY (Mild to
Severe)
Serious /
Notserious
Dizzy
?
26APR2011
26APR2011
?