pharma careers 101 an overview presented by: janice albert, msc. pharmacology phd candidate,...
TRANSCRIPT
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