keys to a successful career in industry: establishing ... · • medical writing • regulatory •...
TRANSCRIPT
![Page 1: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/1.jpg)
Keys to a Successful Career in Industry:
Establishing Yourself and Advancing within the
Company
Christian H. Poehlein, MD
Senior Global Clinical Lead
Bayer Healthcare Oncology
SITC Annual Meeting
Sunday, November 09, 2014
![Page 2: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/2.jpg)
2
Christian Poehlein, MD
The following relationships exist related to this presentation:
Bayer HCP Oncology, Employee
![Page 3: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/3.jpg)
![Page 4: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/4.jpg)
• Start-up (Academia or VC)
• Small Biotech (< 100 Employees)
• Midsize Biotech (< 400 Employees)
• Fullsize Biotech (< 5000 Employees)
• Biopharma (>5000 - < 25000 Employees)
• Big Pharma (> 25000 Employees)
![Page 5: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/5.jpg)
• Start-up (Academia or VC)
• Small Biotech (< 100 Employees)
• Midsize Biotech (< 400 Employees)
• Fullsize Biotech (< 5000 Employees)
• Biopharma (>5000 - < 25000 Employees)
• Big Pharma (> 25000 Employees)
Indiv
idual/
Com
pany R
isc
![Page 6: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/6.jpg)
• Start-up (Academia or VC)
• Small Biotech (< 100 Employees)
• Midsize Biotech (< 400 Employees)
• Fullsize Biotech (< 5000 Employees)
• Biopharma (>5000 - < 25000 Employees)
• Big Pharma (> 25000 Employees)
Indiv
idual/
Com
pany R
isc
Matrix
Team
support
![Page 7: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/7.jpg)
• Start-up (Academia or VC)
• Small Biotech (< 100 Employees)
• Midsize Biotech (< 400 Employees)
• Fullsize Biotech (< 5000 Employees)
• Biopharma (>5000 - < 25000 Employees)
• Big Pharma (> 25000 Employees)
Indiv
idual/
Com
pany R
isc
Range o
f R
esp
onsi
bilit
ies
Matrix
Team
support
![Page 8: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/8.jpg)
• Start-up (Academia or VC)
• Small Biotech (< 100 Employees)
• Midsize Biotech (< 400 Employees)
• Fullsize Biotech (< 5000 Employees)
• Biopharma (>5000 - < 25000 Employees)
• Big Pharma (> 25000 Employees)
Indiv
idual/
Com
pany R
isc
Range o
f R
esp
onsi
bilit
ies
Matrix
Team
support
Investment Firm, VC, Market Analysis, CRO, GA, Payers,
CME Providers, Regulatory Agencies, Consulting Partners …
![Page 9: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/9.jpg)
Requirements:
BS/MS - PharmD
PhD, VMD
MD
![Page 10: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/10.jpg)
• Discovery
• Pre-clinical POC
• Early Clinical Development
• Late Clinical Development
• Medical Affairs
• Publications
• Medical Writing
• Regulatory
• Safety (Pharmacovigilance)
• Project Management
Requirements:
BS/MS - PharmD
PhD, VMD
MD
![Page 11: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/11.jpg)
• Discovery
• Pre-clinical POC
• Early Clinical Development
• Late Clinical Development
• Medical Affairs
• Publications
• Medical Writing
• Regulatory
• Safety (Pharmacovigilance)
• Project Management
• Market Access
Requirements:
BS/MS - PharmD
PhD, VMD
MD
• Clinical Science Pharmacodynamics/kinetics
• Biomarkers
Discovery …
Assay Development …
QC …
• Data Management
• Biostatistics
• Manufacturing
• Supply – Logistics
• Surveillance Product Integrity
• HEOR
![Page 12: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/12.jpg)
• Discovery
• Pre-clinical POC
• Early Clinical Development
• Late Clinical Development
• Medical Affairs
• Publications
• Medical Writing
• Regulatory
• Safety (Pharmacovigilance)
• Project Management
• Market Access
Requirements:
BS/MS - PharmD
PhD, VMD
MD
• Clinical Science Pharmacodynamics/kinetics
• Biomarkers
Discovery …
Assay Development …
QC …
• Data Management
• Biostatistics
• Manufacturing
• Supply – Logistics
• Surveillance Product Integrity
• HEOR
![Page 13: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/13.jpg)
• Discovery
• Pre-clinical POC
• Early Clinical Development
• Late Clinical Development
• Medical Affairs
• Publications
• Medical Writing
• Regulatory
• Safety (Pharmacovigilance)
• Project Management
• Market Access
Requirements:
BS/MS - PharmD
PhD, VMD
MD
• Clinical Science Pharmacodynamics/kinetics
• Biomarkers
Discovery …
Assay Development …
QC …
• Data Management
• Biostatistics
• Manufacturing
• Supply – Logistics
• Surveillance Product Integrity
• HEOR
![Page 14: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/14.jpg)
• Discovery
• Pre-clinical POC
• Early Clinical Development
• Late Clinical Development
• Medical Affairs
• Publications
• Medical Writing
• Regulatory
• Safety (Pharmacovigilance)
• Project Management
• Market Access
Requirements:
BS/MS - PharmD
PhD, VMD
MD
• Clinical Science Pharmacodynamics/kinetics
• Biomarkers
Discovery …
Assay Development …
QC …
• Data Management
• Biostatistics
• Manufacturing
• Supply – Logistics
• Surveillance Product Integrity
• HEOR
![Page 15: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/15.jpg)
• Discovery
• Pre-clinical POC
• Early Clinical Development
• Late Clinical Development
• Medical Affairs
• Publications
• Medical Writing
• Regulatory
• Safety (Pharmacovigilance)
• Project Management
• Market Access
Requirements:
BS/MS - PharmD
PhD, VMD
MD
• Clinical Science Pharmacodynamics/kinetics
• Biomarkers
Discovery …
Assay Development …
QC …
• Data Management
• Biostatistics
• Manufacturing
• Supply – Logistics
• Surveillance Product Integrity
• HEOR Program Lead …
![Page 16: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/16.jpg)
• Medical School of the Ludwig-Maximilians-Universität (LMU), Munich, Germany
• Doctoral Thesis, Institute for Surgical Research, Transplant Immunology,
• Xenotransplantation, University Clinic Großhadern, Munich, Germany
• Residency, Surgical Clinic and Policlinic, Technical University, Munich, Germany
• Postdoc Research Fellow, Lab of Molecular &Tumor Immunology, EACRI
• Senior Research Scientist, Faculty, Translational Tumor Immunotherapy, EACRI
• Certificate Human Investigations Program (HIP), Oregon Health & Science University
• Global Medical Director, Provenge (sipuleucel-T)
Clinical Development & Medical Affairs, Dendreon, Seattle, WA
• Global Medical Lead, Nivolumab (Anti-PD1) Melanoma and RCC
HQ Bristol-Myers Squibb Company, Princeton, NJ
• Senior Global Medical Lead, Head, Stivarga (regorafenib)
HQ Bayer HCP Oncology, Whippany, NJ
• Senior Global Clinical Leader, Xofigo (Ra223) LCM, Program Lead Multiple Myeloma
HQ Bayer …
1990 - 2010
2010 - present
![Page 17: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/17.jpg)
*
•Get a mentor as your first manager
•Teamwork is essential
•Be aware of your new environment
•Get a mentor, perhaps a coach
•Timelines and Quality are superior than quantity
•Flexibility for rapid change can not be an issue
•Did I mention to get a mentor…? Perhaps a coach
![Page 18: Keys to a Successful Career in Industry: Establishing ... · • Medical Writing • Regulatory • Safety (Pharmacovigilance) • Project Management • Market Access Requirements:](https://reader030.vdocuments.mx/reader030/viewer/2022011907/5f524396ecf7155f90329912/html5/thumbnails/18.jpg)
*
•Get a mentor as your first manager
•Teamwork is essential
•Be aware of your new environment
•Get a mentor, perhaps a coach
•Timelines and Quality are superior than quantity
•Flexibility for rapid change can not be an issue
•Did I mention to get a mentor…? Perhaps a coach
•And don’t forget:
At the end, curing a patient requires the understanding and utilization of the immune system
Ergo…
“Never give up, never surrender and never let anyone tell you to accept the status quo!” CHP 2014