7 Essential Steps To Hiring A Pharmaceutical Consultant

By Ed Miseta, Chief Editor, Clinical Leader

In preparation for the spring 2014 hiring season, The CECON Group has recently developed guidelines for choosing the best consultant for a project. Selecting and managing a technical consultant can be a challenge, especially if the subject matter is well outside of the hiring manager’s field of expertise. In the pharmaceutical industry, consultants can help companies of any size to deal with various aspects of drug development, including the selection of suppliers and outsourcing partners.  

However, when selecting the ideal consultant to help you through any project, there are several factors that must be considered BEFORE beginning your search. Integrating these factors into your selection process will help to ensure that you end up with a consultant that understands your goals and needs, and will contribute the most towards making your project a success. Michael C. Fisher, president of The CECON Group, shared seven steps that must be considered when hiring a consultant, to ensure the success of your project.

Michael C. Fisher, president, The CECON Group

1. Know Your Project Goals: Before starting your search, you must have a clear idea of what you want to accomplish. The better defined the project is, the better results you will get. Having your objectives in written form will help to clarify them for both you and the consultant. Get as many internal employees as possible involved in determining the goals. Most projects, especially the ones in smaller

pharma and biotech companies, will involve several departments within the company. Getting someone from every department involved in the goal setting will ensure that no aspects of the project will get overlooked.

2. Know Their Education And Experience: The members of the management team at your company have widely different backgrounds in terms of education and experience. Some have science backgrounds while others come from the world of business. Some have prior experience working in the life sciences, while others do not. The same is true of consultants. When hiring one, you are paying for skill sets and experience. As such, the consultant you hire should have extensive education and/or experience in the industry or the area germane to your needs. If you are uncertain of the specific technology requirements, utilize a colleague or a consultant referral service that can help you to translate your needs.

In addition, feel free to ask as many questions as necessary to determine if they will be a good fit for your project. Some examples include:

• How long has the consultant been in his/her field? Are they new or do they have a proven track record?
• How long have they been consulting?
• In what therapeutic areas do they have expertise?
• Why did they decide to get into consulting?
• Was their experience with a pharma company or with a partner company?
• Is consulting their new career, or is this just temporary position while transitioning between jobs?

A few additional questions that would not be asked of a consultant, but should nevertheless be a part of the decision-making process, are:

• Do they come recommended to you by a trusted contact in the industry?
• Do they have references from companies and individuals that you know and trust?
• Did you contact them, or did they contact you?

3. Conduct A Thorough Interview: Consultants should offer a pre-project interview. Inappropriate candidates will spend most of that time discussing themselves and their past accomplishments. Try to avoid those candidates. Rather than discussing themselves, ideal candidates will instead listen to your project requirements without interrupting. Once they have a basic understanding of your needs, they will ask a lot of questions in order to truly understand the project requirements. You should feel comfortable with the expert’s approach and your ability to work together. As with any job interview, your comfort level with a candidate will grow when they ask questions and show a heartfelt interest in the job they are applying for. A good understanding of your company, which shows that research into the company was conducted ahead of time, is a big plus. 

4. Request Specific Deliverable(s) For The Project: For your project to be a success, there needs to be a common understanding of what the project will produce. For this step, clarity is absolutely imperative. Sometimes the consultant will need to assist you in determining the specific deliverables. While it may crystallize (or change) during the interview or after the engagement starts, be sure to discuss it so there is alignment before a contract is signed. The deliverables should be specified in writing, so there is no disagreement or ambiguity down the road. If changes are made at some point, make sure those changes are communicated in writing as well. Changes may affect the contract that was signed, so make sure they are discussed with the consultant and agreed upon. 

5. Insist On A Non-Disclosure Agreement (NDA) When Required: If you need an NDA due to the proprietary nature of the technology or business, then always insist on it. If there is doubt, err on the side of safety and get one. Make sure you understand the main terms, which are: length of the agreement, length of the confidentiality period, and ownership of any new technology that may arise during the engagement. An NDA may need to be prepared prior to the interview, so you can fully discuss your project at that time.

6. Prepare A Rock-Solid Contract: This is by far the most important aspect of the process. One of the trickiest aspects of it will be the agreed upon fee structure. More specifically, how does the consultant plan to achieve the project’s goals, and what are the fees they will expect in return?

At a minimum, the contract should specify the following:

• How are travel and other out-of-pocket expenses handled? Are they a pass-through or are they marked up?
• Is this a fixed price agreement, where the total price of the project plus reimbursable(s) is negotiated beforehand?
• Is there a retainer?
• Is the price based on an estimated fee, with an hourly rate and a capped maximum?
• Is there a charge for travel time, and is this for both local and long distance travel?

Sometimes consultants will turn to others in the industry for assistance when working on a project. This is not a problem, since you can’t expect any one individual to be an expert on every aspect of your project. You should, however, have some basic information on any additional individuals who happen to be called in. At a minimum, make sure you know:

• Who else will be working on the project?
• What are their qualifications?
• Does the consultant do the work or hand it off to others?
• If someone else is performing some of the work, will you have an opportunity to approve them?

Additionally, you will need to approve the consultant’s time and expenses. While some latitude is usually given to allow the consultant to do the job, you set the expectations. If the billing becomes 40 hours and you expected 8, you may have yourself to blame. Major expenses should be approved in writing beforehand, and this should also be in the contract.

7. Closely Track The Progress: One of the biggest mistakes you can make when hiring a consultant is not adequately tracking their progress, and then being disappointed when critical deadlines are not met. How does the consultant keep track of the hours spent on the project? Is there a daily or weekly activity log? If so, will you have access to periodically review the progress? Remember, a consultant that you hire is accountable to you, just like anyone else working for you. Hold them accountable for their progress.

In the pharma and biopharma industries, delays in projects can cost companies millions of dollars. When hiring a consultant to run a project, they can make or break it. Gathering as much information on them as possible, preparing the right paperwork, and then tracking the progress will ensure the process goes smoothly and meets all of your objectives.  

About the CECON Group:

The CECON Group has over 200 pharmaceutical experts with an average of more than 25 years of experience offering comprehensive technical support in R&D, CMC, and regulatory strategy and submissions. Contact CECON to help you find the best consultant, or see the pharmaceutical experts listed by a specific discipline.