Career Advice in Pharmacoepidemiology

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  • 1. Career Advice in Pharmacoepidemiology
    Dan Strauss – Klein Hersh International
    Dr. Kourtney Davis - GlaxoSmithKline
  • 2. Content
    Who hires epidemiologists?
    Desired skills/traits in entry-level candidates
    “What do we really do?” – Dr. Kourtney Davis
    Daily life, responsibilities, stakeholders, collaborators
    Marketing/Branding Yourself
    Resume building, social networking
    Interview Tips
  • 3. Background
    Klein Hersh International
    Life Sciences Executive search since ‘98
    #1 firm in network of 1100 worldwide
    400 placements annually
    60-70 per year specific to epidemiology backgrounds
    Epidemiology, Biostatistics, HEOR, Pharmacovigilance, Risk Management, etc.
  • 4. Contributors
    John Acquavella (Executive Director, Epidemiology – Amgen)
    Terri Madison (VP, Epidemiology & Risk Management – Excenda)
    Syed Islam (Senior Director, Pharmacoepidemiology – Abbott)
    Dan Mines (VP, Safety Surveillance & Epidemiology – HealthCore)
    Gregory Daniel (VP, Gov’t& Academic Research – HealthCore)
    Crystal N Holick (Director, Safety & Epidemiology – HealthCore)
    William Blumentals (Head, Epidemiology for Virology – Roche)
    Andres Gomez (Executive Director, Epidemiology – BMS)
    Nancy Santanello (VP, Epidemiology – Merck)
    Robert Reynolds (VP, Epidemiology – Pfizer)
    Jamie Geier (Director, Epidemiology – Pfizer)
    Jesse Berlin (VP, Pharmacoepidemiology – J&J)
    Andre Araujo (VP, Epidemiology – NERI)
  • 5. Companies with Epidemiologists
    Pharmaceuticals, Medical Device, Biotech (Industry)
    GSK, Pfizer, Amgen, J&J, Abbott, Roche, BMS
    Contract Research Organizations (CRO)
    Covance, Quintiles, PAREXEL
    Consulting and Vendor Companies
    Xcenda, Healthcore, SciMetrika
    Pharmaceutical Benefits Management (PBM)
    MedCo, Express Scripts
    Government, Regulatory, and Academia
    -State Government, CDC, FDA, NIH, NERI, Universities
  • 6. Location of Industry Positions
    Major Pharma/Biotech Hubs
    NYC Metro, Philly, Boston, San Fran, Outside USA
    12 of the top-20 earning pharma companies worldwide have offices within 100 miles of NYC.
    Boston/Cambridge increasing
    Philadelphia remains steady
    Chicago/Mid-West
    NC has Pharma and large CRO headquarters
    West Coast (San Fran, San Diego)
  • 7. Industry Salary Information
    Will depend on location
    Geographic location AND location within company
    THERE IS MORE THAN JUST SALARY!!!!!
    Target Bonus %, Long-Term Incentives, Sign-on, etc
    Culture, Growth Opportunities
    Starting Salaries from $60k-85k for an MPH
    Starting Salaries from $70k-110k for a PhD
    Contract/Permanent
    If it is contract, what are the terms?
  • 8. What Hiring Managers Want to See
    Study design / methodological skills
    Logical approach to refining research questions – LOGICAL THINKERS
    Matching designs and data sources to questions-- fit for purpose
    Statistical Analysis
    Familiarity with SAS and other languages (STATA, SPSS, R)
    Can you show how you used it?
    USE OF LARGE DATASETS
    Healthcare claims databases (private and public), disease cohorts, population-based surveys
    Ability to manage the data
    Have you done one of these studies?
    Independent, observational study
    Are you able to briefly describe the study aims, outcome, and impact?
  • 9. What Hiring Managers Want to See
    Expertise/Knowledge of at least one Therapeutic Area
    Have you published independent or collaborative research?
    What studies have you led? Grant proposals written and/or funded?
    Any type of clinical knowledge
    Clinical Education (MD, RPh, RN, PharmD)
    Intro to Pharmacology for non-medical professionals
    Publications and scientific presentations
    Were you the first author of published paper?
    Did you publish your thesis/dissertation?
    Have you made oral or poster presentations at international conferences?
  • 10. What Hiring Managers Want to See
    What EPIDEMIOLOGY activities did you do during your program?
    A study with your professor
    An R.A. focused on epidemiology research or course
    Volunteering – research, clinical, etc
    Teaching introductory classes
    Are you following the current trends?
    Comparative Effectiveness, Health Outcomes
    Safety Studies (Risk Management, REMS)
    Company info
    Mergers/Acquisitions, Success, TA, etc.
  • 11. What Hiring Managers Want to See
    Communication Skills
    Written and Oral
    Diverse audiences (e.g. to non-epidemiologists)
    Influencing and negotiation
    Leadership Qualities
    Managing programmers and contract research support staff
    External issues – CRO, Consulting, Regulations, etc.
    Personality
    Demonstrated teamwork and success in matrix environment
    Keeping the “client” happy
    Internal or external
    Resilience
  • 12. “What do we really do?”
    Dr. Kourtney Davis, PhD
    Senior Director, Worldwide Epidemiology - GSK
  • 13. Who is WWEpi @GSK?
    Part of Quantitative Sciences (QSci) in Medicines Discovery and Development (MDD), GSK Research & Development
    Offices in US (RTP and Philadelphia) and UK (Stockley Park)
    Combined staff of ~60 epidemiologists, programmers/analysts, administrative staff
    WWEPI Mission
    Provide population-based evidence on disease and treatment to influence decision making—from discovery through drug development to medical practice.
    13
  • 14. Epidemiology at GSK - direct input to assets and strategy
    Commit to target
    Tractable hit (CEDD entry)
    Candidate Selection
    Approval for FTIH
    Proof of Concept
    Commit to Phase 2b
    Commit to Phase 3
    Commit to launch
    Labeling
    Changes
    Disease/Target Selection
    Clinical Development Planning
    Risk-Benefit Assessment
    • Disease Epidemiology
  • 15. Incidence, prevalence, mortality
  • 16. Co-morbidity patterns
  • 17. Disease risk factors
  • 18. Natural history of disease
  • 19. Recurrence or progression patterns
  • 20. Genotype-phenotype distributions
  • 21. Disease marker validation
  • 22. Opportunity Assessment
  • 23. Trends, forecasts in patient populations
  • 24. Medical need at population or sub-population level
  • 25. Understanding Treatments
  • 26. Diagnostic and treatment patterns
  • 27. Treatment effectiveness
  • 28. Planning Clinical Programs
  • 29. Size and location of patient population
  • 30. Identification of high-risk sub-populations
  • 31. Assessment of inclusion/exclusion criteria
  • 32. Placebo response
  • 33. Outcome measures
  • 34. Safety Issues
  • 35. Background rates of safety outcomes and lab abnormalities
  • 36. Post-marketing safety studies
  • 37. Pregnancy registries
  • 38. Electronic health records
  • 39. Securing Regulatory Approval & Post-Licensure Commitments
  • 40. Dossiers
  • 41. REMS
  • 42. Risk management plans
  • 43. Formal studies of drug safety and registries
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    Text
    • 1. Career Advice in Pharmacoepidemiology
      Dan Strauss – Klein Hersh International
      Dr. Kourtney Davis - GlaxoSmithKline
  • 2. Content
    Who hires epidemiologists?
    Desired skills/traits in entry-level candidates
    “What do we really do?” – Dr. Kourtney Davis
    Daily life, responsibilities, stakeholders, collaborators
    Marketing/Branding Yourself
    Resume building, social networking
    Interview Tips
  • 3. Background
    Klein Hersh International
    Life Sciences Executive search since ‘98
    #1 firm in network of 1100 worldwide
    400 placements annually
    60-70 per year specific to epidemiology backgrounds
    Epidemiology, Biostatistics, HEOR, Pharmacovigilance, Risk Management, etc.
  • 4. Contributors
    John Acquavella (Executive Director, Epidemiology – Amgen)
    Terri Madison (VP, Epidemiology & Risk Management – Excenda)
    Syed Islam (Senior Director, Pharmacoepidemiology – Abbott)
    Dan Mines (VP, Safety Surveillance & Epidemiology – HealthCore)
    Gregory Daniel (VP, Gov’t& Academic Research – HealthCore)
    Crystal N Holick (Director, Safety & Epidemiology – HealthCore)
    William Blumentals (Head, Epidemiology for Virology – Roche)
    Andres Gomez (Executive Director, Epidemiology – BMS)
    Nancy Santanello (VP, Epidemiology – Merck)
    Robert Reynolds (VP, Epidemiology – Pfizer)
    Jamie Geier (Director, Epidemiology – Pfizer)
    Jesse Berlin (VP, Pharmacoepidemiology – J&J)
    Andre Araujo (VP, Epidemiology – NERI)
  • 5. Companies with Epidemiologists
    Pharmaceuticals, Medical Device, Biotech (Industry)
    GSK, Pfizer, Amgen, J&J, Abbott, Roche, BMS
    Contract Research Organizations (CRO)
    Covance, Quintiles, PAREXEL
    Consulting and Vendor Companies
    Xcenda, Healthcore, SciMetrika
    Pharmaceutical Benefits Management (PBM)
    MedCo, Express Scripts
    Government, Regulatory, and Academia
    -State Government, CDC, FDA, NIH, NERI, Universities
  • 6. Location of Industry Positions
    Major Pharma/Biotech Hubs
    NYC Metro, Philly, Boston, San Fran, Outside USA
    12 of the top-20 earning pharma companies worldwide have offices within 100 miles of NYC.
    Boston/Cambridge increasing
    Philadelphia remains steady
    Chicago/Mid-West
    NC has Pharma and large CRO headquarters
    West Coast (San Fran, San Diego)
  • 7. Industry Salary Information
    Will depend on location
    Geographic location AND location within company
    THERE IS MORE THAN JUST SALARY!!!!!
    Target Bonus %, Long-Term Incentives, Sign-on, etc
    Culture, Growth Opportunities
    Starting Salaries from $60k-85k for an MPH
    Starting Salaries from $70k-110k for a PhD
    Contract/Permanent
    If it is contract, what are the terms?
  • 8. What Hiring Managers Want to See
    Study design / methodological skills
    Logical approach to refining research questions – LOGICAL THINKERS
    Matching designs and data sources to questions-- fit for purpose
    Statistical Analysis
    Familiarity with SAS and other languages (STATA, SPSS, R)
    Can you show how you used it?
    USE OF LARGE DATASETS
    Healthcare claims databases (private and public), disease cohorts, population-based surveys
    Ability to manage the data
    Have you done one of these studies?
    Independent, observational study
    Are you able to briefly describe the study aims, outcome, and impact?
  • 9. What Hiring Managers Want to See
    Expertise/Knowledge of at least one Therapeutic Area
    Have you published independent or collaborative research?
    What studies have you led? Grant proposals written and/or funded?
    Any type of clinical knowledge
    Clinical Education (MD, RPh, RN, PharmD)
    Intro to Pharmacology for non-medical professionals
    Publications and scientific presentations
    Were you the first author of published paper?
    Did you publish your thesis/dissertation?
    Have you made oral or poster presentations at international conferences?
  • 10. What Hiring Managers Want to See
    What EPIDEMIOLOGY activities did you do during your program?
    A study with your professor
    An R.A. focused on epidemiology research or course
    Volunteering – research, clinical, etc
    Teaching introductory classes
    Are you following the current trends?
    Comparative Effectiveness, Health Outcomes
    Safety Studies (Risk Management, REMS)
    Company info
    Mergers/Acquisitions, Success, TA, etc.
  • 11. What Hiring Managers Want to See
    Communication Skills
    Written and Oral
    Diverse audiences (e.g. to non-epidemiologists)
    Influencing and negotiation
    Leadership Qualities
    Managing programmers and contract research support staff
    External issues – CRO, Consulting, Regulations, etc.
    Personality
    Demonstrated teamwork and success in matrix environment
    Keeping the “client” happy
    Internal or external
    Resilience
  • 12. “What do we really do?”
    Dr. Kourtney Davis, PhD
    Senior Director, Worldwide Epidemiology - GSK
  • 13. Who is WWEpi @GSK?
    Part of Quantitative Sciences (QSci) in Medicines Discovery and Development (MDD), GSK Research & Development
    Offices in US (RTP and Philadelphia) and UK (Stockley Park)
    Combined staff of ~60 epidemiologists, programmers/analysts, administrative staff
    WWEPI Mission
    Provide population-based evidence on disease and treatment to influence decision making—from discovery through drug development to medical practice.
    13
  • 14. Epidemiology at GSK - direct input to assets and strategy
    Commit to target
    Tractable hit (CEDD entry)
    Candidate Selection
    Approval for FTIH
    Proof of Concept
    Commit to Phase 2b
    Commit to Phase 3
    Commit to launch
    Labeling
    Changes
    Disease/Target Selection
    Clinical Development Planning
    Risk-Benefit Assessment
    • Disease Epidemiology
  • 15. Incidence, prevalence, mortality
  • 16. Co-morbidity patterns
  • 17. Disease risk factors
  • 18. Natural history of disease
  • 19. Recurrence or progression patterns
  • 20. Genotype-phenotype distributions
  • 21. Disease marker validation
  • 22. Opportunity Assessment
  • 23. Trends, forecasts in patient populations
  • 24. Medical need at population or sub-population level
  • 25. Understanding Treatments
  • 26. Diagnostic and treatment patterns
  • 27. Treatment effectiveness
  • 28. Planning Clinical Programs
  • 29. Size and location of patient population
  • 30. Identification of high-risk sub-populations
  • 31. Assessment of inclusion/exclusion criteria
  • 32. Placebo response
  • 33. Outcome measures
  • 34. Safety Issues
  • 35. Background rates of safety outcomes and lab abnormalities
  • 36. Post-marketing safety studies
  • 37. Pregnancy registries
  • 38. Electronic health records
  • 39. Securing Regulatory Approval & Post-Licensure Commitments
  • 40. Dossiers
  • 41. REMS
  • 42. Risk management plans
  • 43. Formal studies of drug safety and registries
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