Part II: The different job functions and main responsibilities

In the previous article, I gave insights into the benefits of working in a CRO and what are the main differences. As a summary,?

• Global CROs : Offices in many countries, strong support structures and very stable.?
• Specialist CROs: Allow people to focus in 1 area such as data, oncology etc
• Local CROs: Usually family like environments with specialist knowledge of a local country or region.?

In this overview, I discuss the 3 most important areas of a Medical Doctor in a CRO, including how this helps drug development and your career in general.??

1. Medical Monitoring.?
2. Signal management and Risk : Benefit.?
3. Medical Expertise / Business Development.

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Medical Monitoring?

Short summary: Analysing the disease progression, side-effects and anything else related to the health of the patient during the clinical trial.?

Drug Development Importance: Without this data, it's impossible to track the efficacy, safety and reliability of the clinical trial. An M.D is usually required, especially when dealing with complicated diseases (cancer, neurology) as the medical background helps provide greater certainty, safety and analysis of results.?

When a trial has reliable medical monitoring data, the decision makers (the sponsors/funders) can make better informed decisions on how to progress their trial. Continue investing and search for that cure or end the trial here due to safety/efficacy.?

Career importance: Any biotech or pharma will expect you to continue working with the data and as a medical monitor. Usually only those who are Group Head or above at Pharma companies stop doing this, even Chief Medical Officers at Biotechs still regularly perform medical monitoring activities.?

Signal management and Risk : Benefit?

Short Summary:? Similar to medical monitoring, this is a global surveillance of “Signals” or “Cases” to adverse drug events/reactions (ADE/ADRs). This is run from Phase I to IV but the data becomes more actionable at Phase III with larger and more diverse patient cohorts.?

Drug Development Importance: If the same adverse drug event keeps happening to a certain % of patients, are the benefits of that drug better than the risks? Think Aduhelm (Alzheimers) at Biogen or experimental cancer treatments vs. proven ones.?

Further, failed drug inspections and audits means delays, filing windows to be missed and millions lost. If a biosimilar fails to be the 1st drug on the market post drug patent cliff, they can typically lose up to 20% of the market share - huge.?

Career importance: All the skills developed in a CRO are directly transferable to the sponsor side, without them it's very hard to truly get the whole picture during Risk:Benefit planning or inspections. All my clients love to see 2+ years of CRO work doing such activities.?

Medical Expertise / Business Development?

Short Summary: Medical Doctors bring authority and credibility to CROs. This helps the Business Development team approach sponsors. You will help answer medical questions, reassure the clients (sponsors or sites) that your group can be trusted and potentially even join business pitches.?

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Drug Development Importance: If you believe your CRO is truly great (which I hope you do if you work there) then you will help bring more drugs to patients, quicker, cheaper and with more certainty.?

Career Importance: Understanding the relationship between CRO / Sponsor is essential, especially at a more senior level. When you reach VP or C level, you will be involved in sponsor selections - the best way to know what makes a good partner is to see both sides.??

There exist many more activities an MD might be involved in, study protocol development, regulatory reports, medical writing, leadership etc.

From my many conversations with hiring managers and candidates however these are the 3 most important areas I hear from candidates.?

If you are a M.D in Europe and looking to move into the industry then please get in touch - all conversations private and confidential.?

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