Careers in Pharmacology and Toxicology

1. Careers in Pharmacologyand Toxicology Kurt W. Carlson, Ph.D. kcarlson@kinemed.net

2. Career Areas • Academia • Professional • Government • Industry

3. Academia • Basic Research (M.D. or Ph.D.) • Grad Student/Post-Doc/PI • Research Associate (Bachelor/Master) • Clinical Research (M.D./Ph.D./Pharm.D.) • Investigator Sponsored Clinical Trials • Liaison with Industry/Government

4. Professional • M.D. • Pharm.D.

5. Government • FDA • NIH • EPA • DoD • USPTO

6. FDA • Regulates: • Food • Drugs • Biologics • Medical Devices

7. Drugs • Center for Drug Evaluation and Research • CDER ensures safe and effective drugs are available to improve patient and consumer health • Small molecule oriented/pharmaceutical industry focus

8. CDER • Employs: • Biologists • Chemists (Medicinal/Pharmaceutical) • Physicians • Pharmacologists • Toxicologists

9. CDER Pharmacologists • Non-Laboratory Responsibilities: • Review/evaluate pharmacological and toxicological data in NDAs and INDs • Submit recommendations for approval

10. CDER Pharmacologists • Laboratory Research Includes: • The absorption and metabolism of chemicals • The disposition of xenobiotics in normal and diseased animals • The effects of drugs and toxins from the molecular level to the total body response

11. Location/Salaries • Employment only in Washington D.C. • Starting Salaries (basic pay): • $36,050 (Bachelor level) • $43,621 (Master level) • $86,417 (Doctorate level)

12. Biologics • Center for Biologics Evaluation and Research • CBER has the same mission as CDER but evaluates vaccines, gene therapy, recombinant protein, monoclonal antibody products • Biologics oriented/biotechnology industry focus

13. CBER • Similar employment areas as CDER but more focused on the biological sciences: • MCB • Microbiology • Physiology • Pharmacology • Toxicology • Interdisciplinary Scientist • (salary range: $70,519 - $91,672)

14. NIH • Non-regulatory – “the Steward of Medical and Behavioral Research for the Nation” • More Basic Science and Clinical Research • (27 research centers) • Well funded • For FY 04 received $23.5 billion • Lots of jobs • 18,000 employees in Bethesda, MD and around the world

15. EPA • Leads the Nation's environmental science, research, education and assessment efforts • Employs 18,000 • Pharmacologists and Toxicologists • General biologists and physiologists • Environmental Health Scientists • Manages 17 labs • FY 04 budget of $7.6 billion

16. CDC • Centers for Disease Control and Prevention • Promotes health and quality of life by preventing and controlling disease, injury, and disability • Employs 8,500 worldwide • $6.5 billion FY04 budget • Salaries are equivalent to FDA, NIH, EPA • 170 public health disciplines represented • Epidemiology, toxicology, microbiology, virology

17. DoD • Military and civilian positions • Civilian pay comparable to FDA, NIH, EPA • Military pay is lower, but 40% is not taxed • Employs all fields of life sciences • Worldwide and well funded

18. DoD (cont.) • World-class medical research facilities • U.S. Army Medical Research Institute of Infectious Diseases • National Naval Medical Center • Uniformed Services University of the Health Sciences • U.S. Army’s Walter Reed Medical Center • Countering bioterrorism is a major focus but all disease areas are investigated

19. USPTO • Patent Examiner • Requires a Bachelor degree or higher • Examines patents for patentability and grants them if meets statutory criteria • Novelty • Nonobviousness • Utility

20. USPTO (cont.) • Two-week intense course in patent law • Starting Salary from $45,000 (Bachelor degree) to $75,000 (Ph.D.) • Valuable experience for later private sector employment

21. Industry • Pharmaceutical (Ten largest companies*) • Employs 750,000 worldwide • $183.5 billion in revenue • Ten leading products generated $44.7 billion • $34.4 billion in R&D spending • Concentrated in the Northeast and Midwest * 2002 Figures

22. Industry • Biotechnology (Ten largest companies*) • Employs 38,200 • $15.8 billion in revenue • $3.7 billion in R&D spending • Concentrated in SF, Boston, San Diego, D.C., RTP, (some in NY, Michigan, and Seattle) * 2002 Figures

23. Pharmaceutical/Biotech Careers • Scientist • Research Associate • Regulatory Affairs • Clinical Affairs • Business Development • Venture Capital • Legal

24. Scientist • All types of life scientists and chemists • Generally requires a Ph.D. • Exception: Programs where there is a research associate to scientist career track (e.g., Genentech) • More jobs in the pharmaceutical industry than in biotech • Starting Salary: $70,000. • Biotech pays less/Bay Area pays more

25. Research Associate • All types of life scientists and chemists • Requires a Bachelor degree • Master degree is helpful later in career • More jobs in pharmaceutical than in biotech • Starting Salary: $45,000 • Biotech pays less/Bay Area pays more

26. Regulatory Affairs • Generally Non-entry Level but Lateral Move from Scientist or Research Associate • Focuses on submissions to FDA • IND, Clinical Trials, NDA, BLA, AE reporting • Works with Clinical Affairs and Manufacturing Staff • High Demand and Salaries Reflect this: • $55,000 to $275,000+ (VP level)

27. Clinical Affairs • Clinical Research Associate • A lateral move from Research Associate (unless have a BSN) • Higher level jobs are filled by M.D.s • Another High Demand Area with salaries starting at $55,000 and increasing to $300,000+ for VP position (M.D.)

28. Business Development • Generally Lateral Move from Scientist • VP positions Ph.D., some with MBA • Directors and Managers can have Bachelor/Master degrees + MBA • Not a high demand field but a critical one so well compensated • Starting salary $80,000 to $100,000 • VP level $275,000+

29. Venture Capital • Work in Industry for a few years • Get an MBA – Learn Finance! • Biotech analyst • Advise private capital firms on investment decisions • Burrill & Co. (Life Sciences Merchant Bank in SF), many venture capital firms in SF, Peninsula • Starting salary: $60,000 to $120,000+

30. Legal • Patent Agent • Take Patent Bar Exam • All you need is your MCB or IB degree • Home study sufficient to pass • Registered Patent Agent • Write biotech patent applications • Argue patentability with Patent Examiner • Work in licensing patent applications • Starting salary $80,000

31. Legal (cont.) • Patent Attorney • Why Go to Law School? • Essentially same work as patent agent but can also litigate in court • Starting salary $125,000+ in law firms • Less in industry ($115,000) • Partners in law firms make $400,000+ • VP of IP in industry makes $275,000+ (Ph.D./J.D.)

32. Summary and Conclusion • Bay Area is World Capital of Biotech • Largest concentration of biotech AND venture capital firms that fund biotech • Jobs are most plentiful in science and Regulatory Affairs. Other in-demand jobs are Quality Control, Quality Assurance, and Manufacturing • The business side, BD, VC, and Legal are very lucrative and rewarding career areas • Networking is Vital