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Project Management
     Career in
  Pharma Industry
   Mukesh Kumar, PhD, RAC
    Senior Director, Regulatory Affairs
       Amarex Clinical Research
         Germantown, MD, USA
My Background

    NIH Post-doc and Research Fellow

    Technology Transfer professional

    Clinical trial specialist

    Regulatory Affairs (FDA, EMEA, etc)

    Specialist
    Quality Assurance professional

    Business development professional

                    Google me!
                 www.Amarexcro.com   ©Amarex
Project Management Career
    High-demand for project managers

        Widely accepted as a key element
    
        Lack of trained professionals
    

    Diverse talents required

        Scientific and technical
    
        Legal and business
    
        Human resources and Administrative
    

    Many options to prepare for transition



                  www.Amarexcro.com              3
                                       ©Amarex
How did I do it?



     www.Amarexcro.com   ©Amarex
Decide, Plan, Execute
    Its not for everyone, know your strengths

        Risk in changing careers
    
        Non-traditional training
    
        Long-term commitment
    

    Plan, plan, and plan

        Training pathways
    
            Education, certifications, etc
        
            Workshops, conferences, meetings
        
            Internship, part-time jobs
        

        Network
    
                  www.Amarexcro.com       ©Amarex
NIH, an Ideal Starting Place
    Running a lab teaches you the first steps

        Time management
    
        Cost Management
    
        Human resources
    
        Presentation
    

    Many Resources

        Large and diverse talent pool
    
        Many interest groups
    
        Alumni
    

                    www.Amarexcro.com   ©Amarex
Core Areas to Develop Skills in
    Wide knowledge base

        Need to wear multiple hats
    
        Science and business are different mind-sets
    
        Critical thinking
    

    Ability to manage time and priorities

    Cost management

        Not just because of economic trends
    
        Justifiable and unavoidable
    

    Quality management

        Attention to Detail
    
        Good documentation (records)
    
                     www.Amarexcro.com                  7
                                              ©Amarex
Additional Knowledge Areas
    People skills

        Your PhD and NIH connections could be intimidating
    
        Respect opinion of others: listen
    
        Learn to present yourselves (dress, tone, body language)
    
        Conflict resolution
    

    Communication skills

        Technical writing skills
    
        Speaking skills (e.g., Toastmasters)
    
        Presentation skills
    

    Other skills

        Ethics, integrity, trustworthy
    
        Leadership and Resourcefulness
    




                         www.Amarexcro.com                         8
                                                       ©Amarex
Training Pathways
    Start by planning your work projects

    Identify field of interest

        Attend meetings and conferences
    
        Read, Google
    
        Match strengths to interest
    

    Train yourselves

        Courses: short term and degrees
    
        Projects and internships
    
        Certification(s)
    
        Find mentors
    

    Network

        Meetings, Mixers and conferences: organize and participate
    
        Mentors
    



                          www.Amarexcro.com           ©Amarex
Do’s and Don’ts of Networking
    Not a blatant job search

    Network in the field of interest

        Casting a wider net philosophy could be
    
        counterproductive
        Resource management: you have limited time use
    
        it wisely
    Network both above and below your level

        Help others while you help yourselves
    
        Build your own networks
    

          Networking is a two-way street

                      www.Amarexcro.com         ©Amarex
Everybody Needs a Mentor
Mentors are critical for professional development
    They are

        Advisors
    
        Partners
    
        Role models
    
        Links and connections
    

    But Not

        Recruiters
    
        Parents
    
        Boss
    
        Sole source of information
    

               Mentoring is a two-way street
                         www.Amarexcro.com   ©Amarex
Qualities to look for in a Mentor
    Credible: Reputation and Experience

    Accessible

    Responsible

    Enthusiastic

    Feedback and critique

    Help in career goals

        Introductions and references
    

    Increased network


                   www.Amarexcro.com   ©Amarex
Expectations from a Mentee

    Clear goals

    Take initiative

    Commitment to work

    Honest and open discussions

    Respect space

    Appreciate





                www.Amarexcro.com   ©Amarex
Working in Industry Vs Academia
            Different challenges
     1.
            Different priorities
     2.
            Different measures of success
     3.
            Different rewards
     4.
            Different long-term goals
     5.




Introduction to Project      www.Amarexcro.com             14
                                                 ©Amarex
Management, Second Edition
Thank You!
       &
 All the Best!
Mukesh Kumar, PhD, RAC
  Senior Director, Regulatory Affairs
      Amarex Clinical Research
   Germantown, MD 20874, USA
         Tel: 301-528-7000
  Email: mukeshk@amarexcro.com

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Project Management Career

  • 1. Project Management Career in Pharma Industry Mukesh Kumar, PhD, RAC Senior Director, Regulatory Affairs Amarex Clinical Research Germantown, MD, USA
  • 2. My Background NIH Post-doc and Research Fellow  Technology Transfer professional  Clinical trial specialist  Regulatory Affairs (FDA, EMEA, etc)  Specialist Quality Assurance professional  Business development professional  Google me! www.Amarexcro.com ©Amarex
  • 3. Project Management Career High-demand for project managers  Widely accepted as a key element  Lack of trained professionals  Diverse talents required  Scientific and technical  Legal and business  Human resources and Administrative  Many options to prepare for transition  www.Amarexcro.com 3 ©Amarex
  • 4. How did I do it? www.Amarexcro.com ©Amarex
  • 5. Decide, Plan, Execute Its not for everyone, know your strengths  Risk in changing careers  Non-traditional training  Long-term commitment  Plan, plan, and plan  Training pathways  Education, certifications, etc  Workshops, conferences, meetings  Internship, part-time jobs  Network  www.Amarexcro.com ©Amarex
  • 6. NIH, an Ideal Starting Place Running a lab teaches you the first steps  Time management  Cost Management  Human resources  Presentation  Many Resources  Large and diverse talent pool  Many interest groups  Alumni  www.Amarexcro.com ©Amarex
  • 7. Core Areas to Develop Skills in Wide knowledge base  Need to wear multiple hats  Science and business are different mind-sets  Critical thinking  Ability to manage time and priorities  Cost management  Not just because of economic trends  Justifiable and unavoidable  Quality management  Attention to Detail  Good documentation (records)  www.Amarexcro.com 7 ©Amarex
  • 8. Additional Knowledge Areas People skills  Your PhD and NIH connections could be intimidating  Respect opinion of others: listen  Learn to present yourselves (dress, tone, body language)  Conflict resolution  Communication skills  Technical writing skills  Speaking skills (e.g., Toastmasters)  Presentation skills  Other skills  Ethics, integrity, trustworthy  Leadership and Resourcefulness  www.Amarexcro.com 8 ©Amarex
  • 9. Training Pathways Start by planning your work projects  Identify field of interest  Attend meetings and conferences  Read, Google  Match strengths to interest  Train yourselves  Courses: short term and degrees  Projects and internships  Certification(s)  Find mentors  Network  Meetings, Mixers and conferences: organize and participate  Mentors  www.Amarexcro.com ©Amarex
  • 10. Do’s and Don’ts of Networking Not a blatant job search  Network in the field of interest  Casting a wider net philosophy could be  counterproductive Resource management: you have limited time use  it wisely Network both above and below your level  Help others while you help yourselves  Build your own networks  Networking is a two-way street www.Amarexcro.com ©Amarex
  • 11. Everybody Needs a Mentor Mentors are critical for professional development They are  Advisors  Partners  Role models  Links and connections  But Not  Recruiters  Parents  Boss  Sole source of information  Mentoring is a two-way street www.Amarexcro.com ©Amarex
  • 12. Qualities to look for in a Mentor Credible: Reputation and Experience  Accessible  Responsible  Enthusiastic  Feedback and critique  Help in career goals  Introductions and references  Increased network  www.Amarexcro.com ©Amarex
  • 13. Expectations from a Mentee Clear goals  Take initiative  Commitment to work  Honest and open discussions  Respect space  Appreciate  www.Amarexcro.com ©Amarex
  • 14. Working in Industry Vs Academia Different challenges 1. Different priorities 2. Different measures of success 3. Different rewards 4. Different long-term goals 5. Introduction to Project www.Amarexcro.com 14 ©Amarex Management, Second Edition
  • 15. Thank You! & All the Best! Mukesh Kumar, PhD, RAC Senior Director, Regulatory Affairs Amarex Clinical Research Germantown, MD 20874, USA Tel: 301-528-7000 Email: mukeshk@amarexcro.com