1. 1 Promotion in Management and Research Tracks in Industry Magdalena Alonso-Galicia, PhD Cardiovascular Diseases Department Merck Research Laboratories Rahway, NJ

2. 2 Drug Discovery and Development Pharmaceutical companies Biotech therapeutic companies Molecular diagnostics, drug delivery, vaccines

3. 3 Landing a Job in Biotechnology Industry You were recruited because: –Scientific expertise relevant to human disease –Excellent publishing record –Post-doc research was different from graduate work –Have excellent professional presentation skills –Enthusiastic and eager to get the job done attitude

4. 4 Drug Development Steps Discovery Research: - Target ID and Validation - Lead ID - Lead Optimization Preclinical Research: - Drug Safety Assessment: Pharm, Tox, Path - Metabolism & Pharmacokinetics - Chemical Process Development Clinical Development & Regulatory Affairs: - Clinical Trials: Phase I, II, IIIA - Drug Scale-Up & Manufacturing - NDA Filing - FDA Review - Product Launch IND Filing Medical Affairs: - Commercial Operations and Sales - Clinical trials: Phase IIIB, IV Career tracks: Research (or Scientific) And Management Experimental Medicine

5. 5 Career Tracks in Drug Discovery Research Research or Scientific Track: –Most scientists start out at the bench –Roles and responsibilities: Conducting research Team participation Staff management –Typical career progression: Senior Scientist Research Fellow Senior Research Fellow Senior Investigator

6. 6 Career Tracks in Drug Discovery Research Management Track: –Manage and lead scientists in a particular therapeutic area or discipline –Roles and responsibilities: Scientific oversight Recruiting and building teams Resource allocation Staff performance –Typical career progression: Group Leader Manager Director VP

7. 7 How is success measured? Contributions to the company: –Discovery research: number & quality of preclinical drug candidates –Pre-clinical and beyond: drugs in clinical trials and in the market Soft skills: –Meet goals on time –Team building skills –Making GO / NO GO decisions It is important to decide early in your career how you define success and to determine what to do to achieve your goals. –Enlisting the help of a coach or mentor is highly recommended.

8. 8 Achieving your first promotion Scientific leadership Passion and perseverance A collegial attitude and demonstration that you are a good team player A flexible attitude Demonstrate that you add value to the company (contributions to individual projects, initiative)

9. 9 Working towards your second promotion Continue contributing to company success –Lead a project. –Continue building your leadership skills on how to manage & motivate direct reports and team members. Decision point: –Research or Management track?

10. 10 Dreams vs. Reality Pyramid system, few positions available in the management track Pros about Discovery Research careers: –Team-oriented environment; goal is to develop a product that will eventually help mankind. –Great deal of intellectual stimulation. Innovation is critical to the success of drug discovery. –Opportunity to work on multiple molecular targets & therapeutic areas. –Access to the latest technology and infrastructure, large resources. –Job variety.

11. 11 Dreams vs. Reality Cons about Discovery Research careers: –Science is not the only thing driving decisions. –Failure rate is very high. –Expect to work long hours - 50-60 hr a week and some weekends. –Many team meetings to attend. –Discovery research jobs are unstable. –You do not decide which scientific area you will be working on. –You might not be able to publish results until patents are issued.

12. 12 Career Opportunities Discovery research is a launching platform for just about any career direction in biotechnology companies (large pharma, biotech, venture capital, etc.) Discovery Research Preclinical Research Regulatory Affairs Clinical Affairs Project Management Patent Law Venture Capital Consultant VP R&D Other: Business Development Marketing and Sales Medical Affairs

13. 13 References Freedman T. 2008. Career Opportunities in Biotechnology and Drug Development. New York: Cold Spring Harbor Laboratory. Cohen C. and Cohen S. 2005. Lab Dynamics: Management Skills for Scientists. New York: Cold Spring Harbor Laboratory.