The Organization of Business Company Functional and Organizational Structures Brad Fackler, MBA Industry Career Advisor, OITE brad.fackler@nih.gov

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 2. Make their product

3. Sell their product

4. Account for cash inflow and

outflow

Research and Development Operations

Commercial Finance

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

• 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

Flat Organization

Res.

Executive Management

Reg.

Dev. Manf.

QA

BD

Sales.

Mktg.

IT

Leg.

HR

Acctg.

Fin.

Hierarchical Organization

Executive Management

R&D Opns. Comm. F&A

Reg.

Dev.

Res. Manf..

QA

BD

Sales.

Mktg..

IT

Leg.

HR

Acctg.

Matrix Organization

Executive Management

R&D Opns. Comm. F&A

Reg.

QA

IT

Leg.

HR

Acctg.

BD

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

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

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

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

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

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

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

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