the organization of business - national institutes of health
TRANSCRIPT
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The Organization of Business Company Functional and Organizational Structures Brad Fackler, MBA Industry Career Advisor, OITE [email protected]
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Example Job Posting
Position in Pre-clinical Development COMPANY: Achillion Pharmaceuticals, Inc. POSITION: Director, Formulation Development REPORTS TO Senior Vice President Regulatory and Chief Compliance Officer RESPONSIBILITIES : Guide the development of product formulations at all stages of development. Establish the physical form and properties of end products to meet development requirements. Conduct formulation development studies at the preclinical stage. Collaborate with R&D and Manufacturing in process and product specification. Supervise contract research and contract manufacturing organizations CANDIDATE QUALIFICATIONS PhD with a life sciences concentration. Several years' industry experience preferred. Liquid dosage experience. Technologically up-to-date with regard to the manufacture of insoluble drug formulations
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Goals
Provide an understanding of the critical functions within all businesses
Examine how businesses are organized in order to perform those functions
Introduce you to company roles and job titles within R & D
Introduce you to key tools and business terms
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In order to succeed, a business must perform four functions:
1. Create their product / service 2. Make their product
3. Sell their product
4. Account for cash inflow and
outflow
Research and Development Operations
Commercial Finance
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Corporate Functions - Expanded 1. Research and Development
Research – Product discovery Development – Market readiness Regulatory – Product approval
2. Operations Manufacturing – Product production Quality Assurance – Compliance with Standards
3. Commercial Marketing – Product strategy Sales – Product promotion Business Development – Product acquisition / divestiture
4. Finance / Administration Accounting - Revenue and payment obligations Finance – Fiscal planning, reporting HR / IT / Legal
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A Functional Organization
• Conceive products • Market readiness • Product approval
Research / Development
Executive Management
Operations Commercial Finance / Administration
• Manufacturing • Quality assurance
• Product strategy • Product promotion • Product acquisition /
divestiture
• Sales accounting • Pay obligations • Compensation • HR • IT • Legal
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Flat Organization
Res.
Executive Management
Reg.
Dev. Manf.
QA
BD
Sales.
Mktg.
IT
Leg.
HR
Acctg.
Fin.
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Hierarchical Organization
Executive Management
R&D Opns. Comm. F&A
Reg.
Dev.
Res. Manf..
QA
BD
Sales.
Mktg..
IT
Leg.
HR
Acctg.
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Matrix Organization
Executive Management
R&D Opns. Comm. F&A
Reg.
QA
IT
Leg.
HR
Acctg.
BD
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Job Titles
Chief Scientific Officer
or Vice President R&D
Chief Executive Officer or
President
Vice President Operations
Chief Commercial Officer
or Vice President
Marketing & Sales
Chief Financial Officer
or Vice President
Finance
• VP Research • VP Development • VP Regulatory
• VP Manufacturing • VP Quality
• VP Marketing • VP Sales • VP Business
Development
• VP Accounting • VP HR • VP IT • VP Legal
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Job Titles CEO
Chief Operating Officer
Vice President R&D Vice President
Marketing & Sales
Chief Financial Officer
or Vice President
Finance
• VP Research • VP Development • VP Regulatory
• VP Manufacturing • VP Quality • VP HR • VP IT • VP Legal
• VP Marketing • VP Sales • VP Business
Development
• VP Accounting
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R & D Functions
Vice President Research
Chief Scientific Officer (CSO)
Vice President Pre-clinical
Development
Vice President Clinical
Development
Career Tracks Target identification Target validation Assay development New chemical entity development
Roles and Responsibilities Conducting discovery research Team participation and management
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R & D Functions
Vice President Research
Chief Scientific Officer (CSO
Vice President Pre-clinical
Development
Vice President Clinical
Development
Career Tracks Metabolism and Pharmacokinetics
ADMET (absorption, distribution, metabolism, excretion, toxicity) DMPK (drug metabolism and pharmacokinetics)
Toxicology, Drug Safety Evaluation and Pathology Pharmacology Translational Research and Medicine Animal Services and Welfare Chemistry Manufacturing and Controls, and Biologics
Roles and Responsibilities Characterizing drug candidates Evaluating and selecting the most promising drug candidates Conducting preclinical studies during clinical development
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R & D Functions
Vice President Research
Chief Scientific Officer (CSO
Vice President Pre-clinical
Development
Vice President Clinical
Development
Career Tracks Program management Clinical research associates (CRA) and
coordinators
Roles and Responsibilities Design / monitor clinical trials Clinical trial oversight Data verification and regulatory oversight
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Departmental Job Titles
Vice President Research
Chief Scientific Officer (CSO)
Vice President Pre-clinical
Development
Vice President Clinical
Development
Director
Manager
Senior Scientist Staff Scientist Scientist 1, 2, 3 Research Associate Research Fellow
Director
Manager
Senior Scientist Staff Scientist Scientist 1, 2, 3 Research Associate Research Fellow
Director
Medical Monitor Program Manager Clinical Research Scientist Clinical Research Associate Contract Administrator
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CSO
CEO
VP Opns CCO CFO
Board of Directors
Make-up: 3 to 15 business executives Independent (external) Directors – not part of company management Internal Directors – Company management (often CEO and/or CFO) Role: Oversight of proper financial and reporting responsibilities
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What is the world’s largest pharmaceutical company based on 2014 revenues?
A. Sanofi B. Roche C. Pfizer D. Novartis E. Johnson & Johnson
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Key Terms - Operations
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What is a system of controls for research laboratories to ensure product uniformity, consistency, reliability, reproducibility and quality?
A. SOP B. GLP C. GMP D. SKU E. Pilot Plant
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What is a unique identifier for every product manufactured and sold?
A. SOP B. GLP C. GMP D. SKU E. Pilot Plant
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What are guidelines recommended by agencies that control authorization and licensing for the manufacture and sale of food and active pharmaceutical products?
A. SOP B. GLP C. GMP D. SKU E. Pilot Plant
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Board of Directors / Finance • Key Reports • Key Terms
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Financial Report Examples Cash Flow Statement Income Statement
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Financial Report Examples
Balance Sheet Statement of Shareholder Equity
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What is total revenue received before any deductions or allowances? A. Gross Income B. Gross Profit C. Net Profit D. Revenues
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What is the return made on a business transaction, sale, etc., or during a specific period of business activity, after deducting all costs from gross receipts?
A. Gross Income B. Gross Profit C. Net Profit D. Revenues
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What is a measure of company profits used to compare across different companies and in different industries because it nulls the effects of the different capital structures and tax rates used by different companies?
A. EBIT B. COGS C. GAAP
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This is the first sale of stock by a company to the public. A. Public Company B. Private Company C. IPO D. Sarbanes – Oxley
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Key Terms - Commercial
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The distribution of promotional investment in an attempt to optimize return. A. Brand Identity B. Brand Image C. Marketing Mix D. 4 P’s E. Product Life Cycle F. Market Share G. Quantitative Research H. Qualitative Research
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The impression of a product held by real or potential consumers. A. Brand Identity B. Brand Image C. Marketing Mix D. 4 P’s E. Product Life Cycle F. Market Share G. Quantitative Research H. Qualitative Research
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The path through which goods and services travel from the vendor to the consumer.
A. Share of Voice B. Distribution Channel C. Product Features D. Product Advantages E. Product Benefits F. Segmentation G. Targeting H. Positioning
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A strategy that aims to make a brand occupy a distinct position, relative to competing brands, in the mind of the customer
A. Share of Voice B. Distribution Channel C. Product Features D. Product Advantages E. Product Benefits F. Segmentation G. Targeting H. Positioning
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Resources Books
Career Opportunities in Biotech and Drug Development (Freedman) Alternative Careers for Scientists (Robbins-Roth) Non-traditional Careers for Scientists (Kreeger)
Attend Industry Career Series workshops Industry Overview and Job Packages A Practical Guide to Networking Industry Interviews Negotiating the Offer and Transitioning
The OITE Careers blog A variety of industry focused articles
Make an appointment with me using the Scheduling App on the OITE web site to discuss industry career opportunities
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