The Organization of Business Company Functional and Organizational Structures Brad Fackler, MBA Industry Career Advisor, OITE [email protected] 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 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 In order to succeed, a business must perform four functions: 1. Create their product / service Research and Development 2. Make their product Operations 3. Sell their product Commercial 4. Account for cash inflow and Finance outflow 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 A Functional Organization Executive Management Research / Finance / Operations Commercial Development Administration • Conceive products • Manufacturing • Product strategy • Sales accounting • Market readiness • Quality assurance • Product promotion • Pay obligations • Product approval • Product acquisition / • Compensation divestiture • HR • IT • Legal Flat Organization Executive Management Res. Reg. QA Sales. Fin. HR IT Dev. Manf. Mktg. BD Acctg. Leg. Hierarchical Organization Executive Management R&D Opns. Comm. F&A Res. Manf.. Mktg.. Acctg. Dev. QA Sales. HR Reg. BD Leg. IT Matrix Organization Executive Management R&D Opns. Comm. F&A Reg. Acctg. QA HR BD Leg. IT Job Titles Chief Executive Officer or President Chief Scientific Chief Commercial Chief Financial Officer Vice President Officer Officer or Operations or or Vice President R&D Vice President Vice President Marketing & Sales Finance • VP Research • VP Manufacturing • VP Marketing • VP Accounting • VP Development • VP Quality • VP Sales • VP HR • VP Regulatory • VP Business • VP IT Development • VP Legal Job Titles CEO Chief Operating Officer Chief Financial Officer Vice President or Vice President R&D Marketing & Sales Vice President Finance • VP Research • VP Manufacturing • VP Marketing • VP Accounting • VP Development • VP Quality • VP Sales • VP Regulatory • VP HR • VP Business • VP IT Development • VP Legal R & D Functions Chief Scientific Officer (CSO) Vice President Vice President Vice President Research Pre-clinical Clinical Development Development Roles and Responsibilities Conducting discovery research Team participation and management Career Tracks Target identification Target validation Assay development New chemical entity development R & D Functions Chief Scientific Officer (CSO Vice President Vice President Vice President Research Pre-clinical Clinical Development Development Roles and Responsibilities Characterizing drug candidates Evaluating and selecting the most promising drug candidates Conducting preclinical studies during 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 R & D Functions Chief Scientific Officer (CSO Vice President Vice President Vice President Research Pre-clinical Clinical Development Development Roles and Responsibilities Design / monitor clinical trials Clinical trial oversight Data verification and regulatory oversight Career Tracks Program management Clinical research associates (CRA) and coordinators Departmental Job Titles Chief Scientific Officer (CSO) Vice President Vice President Vice President Research Pre-clinical Clinical Development Development Director Director Director Manager Manager Senior Scientist Senior Scientist Medical Monitor Staff Scientist Staff Scientist Program Manager Scientist 1, 2, 3 Scientist 1, 2, 3 Clinical Research Research Associate Research Associate Scientist Research Fellow Research Fellow Clinical Research Associate Contract Administrator Board of Directors CEO CSO VP Opns CCO CFO 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 What is the world’s largest pharmaceutical company based on 2014 revenues? A. Sanofi B. Roche C. Pfizer D. Novartis E. Johnson & Johnson Key Terms - Operations 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 What is a unique identifier for every product manufactured and sold? A. SOP B. GLP C. GMP D. SKU E. Pilot Plant 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 Board of Directors / Finance • Key Reports • Key Terms Financial Report Examples Cash Flow Statement Income Statement Financial Report Examples Balance Sheet Statement of Shareholder Equity What is total revenue received before any deductions or allowances? A. Gross Income B. Gross Profit C. Net Profit D. Revenues 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 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 This is the first sale of stock by a company to the public. A. Public Company B. Private Company C. IPO D. Sarbanes – Oxley Key Terms - Commercial 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 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 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 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 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 .