BIO:ON Career

Biotech interview question bank

Interview questions built from the real industry news BIO:ON has covered. Pick a role, answer out loud first, then compare with the answer points.

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Q1On-the-job scenarioMedical affairsSales & marketing
You’re asked to put out a press release calling a not-yet-approved product ‘an innovative treatment.’ What do you do?
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What the interviewer is looking for
Your compliance instincts — always checked in sales, medical and marketing roles.
Answer points
Promoting an unapproved medicine can breach the rules (example: the UK PMCPA ruled against a Lilly press release).
Alternative: reframe it as factual corporate or clinical news, reviewed by medical, legal and compliance.
Attitude: say that sticking to the rules under pressure protects the company and the brand in the long run.
Based on: Issue #18 · One company, three battlegrounds — same week, same headline name
Q2Explain a conceptBDMarket accessSales & marketing
A deal is ‘worth up to $3.35B,’ but only about 3% is guaranteed. What are bio-dollars?
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What the interviewer is looking for
Whether you read headline numbers critically — an attitude that earns trust in any role, not just BD.
Answer points
Bio-dollars = the headline total of a deal, mostly conditional milestones.
Lilly × Innocare: of up to $3.35B, the guaranteed upfront and near-term payments were about $100M (~3%).
Habit: split out the upfront, milestone conditions and royalties, and talk about the ‘real value.’
Based on: Issue #18 · One company, three battlegrounds — same week, same headline name
Q3Explain a conceptCMC & QARegulatory affairs
What is CMC, and why do drugs sometimes get rejected over ‘manufacturing issues’?
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What the interviewer is looking for
Whether you understand what happens after research — especially how manufacturing and quality affect approval.
Answer points
CMC = Chemistry, Manufacturing & Controls: proof that the drug can be made to the same quality every time.
However good the efficacy, no approval without proven manufacturing consistency.
Example: Ultragenyx’s Fayuvi was rejected over manufacturing, then approved after fixes ($3.95M).
Based on: Issue #17 · The edge in drugs is moving — from what you discover to how you make it
Q4On-the-job scenarioMarket accessInvestment & IR
How can a one-time gene therapy priced at $3.95M be justified?
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Q5Explain a conceptMedical affairsClinical development
What’s the difference between a surrogate endpoint (like PFS) and overall survival (OS), and why does it matter?
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Q6Industry issueRegulatory affairsMedical affairs
The FDA approved a drug despite a negative advisory committee vote. How would you read that?
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Q7Explain a conceptRegulatory affairsR&D
How does an antisense oligonucleotide (ASO) therapy work?
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Q8On-the-job scenarioClinical developmentMedical affairs
A patient death is reported in an ongoing trial. How should the clinical team respond?
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Q9On-the-job scenarioBDInvestment & IR
Brief your leadership on the Hanmi–Roche obesity deal (up to $2.5B) in one paragraph.
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Q10Industry issueRegulatory affairsClinical development
How do vector safety issues in gene therapy affect approval?
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Q11Industry issueClinical developmentBD
Is it better to go head-to-head with Keytruda, or to combine with it?
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Q12Explain a conceptR&DMedical affairs
How does a personalised mRNA cancer vaccine work?
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Q13On-the-job scenarioCMC & QARegulatory affairs
Glass particles are found in one batch of an approved biosimilar. As the quality lead, what do you do first?
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Q14Explain a conceptR&DCMC & QA
How is a molecular glue (targeted protein degradation) different from a traditional inhibitor?
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Q15Explain a conceptRegulatory affairsInvestment & IR
How is a favourable FDA advisory committee vote different from final approval?
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Q16Industry issueBDR&D
Do you agree that the edge in AI drug discovery is shifting from ‘compute’ to ‘data’?
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Q17Explain a conceptClinical developmentSales & marketing
What’s the difference between single GLP-1, dual GLP-1/GIP and triple agonist obesity drugs?
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Q18On-the-job scenarioMarket accessCMC & QA
What are the pros and cons of building a supply chain before approval (e.g. Merck’s alimatravir)?
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Q19Explain a conceptRegulatory affairsMedical affairs
What is an FDA complete response letter (CRL), and how does publishing them affect companies?
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Q20On-the-job scenarioClinical developmentMedical affairs
A drug missed its primary endpoint in Phase 2, but the company decided to go to Phase 3. How would you judge that decision?
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Q21On-the-job scenarioMarket accessSales & marketing
A new drug with proven efficacy is off to a slow first month of prescriptions. What are the likely causes, and what would you do?
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Q22Explain a conceptR&DMedical affairsSales & marketing
Explain an ADC (antibody-drug conjugate) to someone without a science background.
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Q23Explain a conceptBDInvestment & IR
What is the patent cliff, and how does Big Pharma respond to it?
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Q24On-the-job scenarioBDRegulatory affairs
You see a headline: ‘AI drug deal worth up to $600M.’ What do you check first?
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Q25Industry issueRegulatory affairsBD
China’s NMPA approved the world’s first solid-tumour CAR-T. Does that mean global approval?
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Q26On-the-job scenarioCMC & QAClinical development
If in vivo CAR-T is commercialised, how would CAR-T manufacturing and supply change?
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Q27Explain a conceptRegulatory affairsCMC & QA
How is a biosimilar different from a small-molecule generic, and why does being the first entrant matter?
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Q28Industry issueR&DBD
If you had to invest in one of biosimilars, bispecifics or a first-in-class new target, which would you choose and why?
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Q29Explain a conceptBDInvestment & IR
Explain the logic behind Big Pharma paying a 40% acquisition premium.
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Q30Industry issueClinical developmentBD
In an obesity market dominated by Novo and Lilly, how can a latecomer differentiate?
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Q31On-the-job scenarioInvestment & IRBD
A biotech with no revenue and no product saw its stock jump 60% just from a name change. How would you judge its value?
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Q32Explain a conceptRegulatory affairsClinical development
When a Phase 3 result is reported, what do the hazard ratio and the p-value each tell you?
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Q33Explain a conceptR&DClinical development
Compare ex vivo and in vivo approaches to gene therapy.
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Q34Industry issueR&DBD
Why was KRAS ‘undruggable’ for 30 years, and how has a recent drug got around it?
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Questions and answer points were drafted by AI from the newsletter text and reviewed by me. Use them as a skeleton for your answer, not a script.

Biotech interview question bank

You’re asked to put out a press release calling a not-yet-approved product ‘an innovative treatment.’ What do you do?

What the interviewer is looking for

Answer points

A deal is ‘worth up to $3.35B,’ but only about 3% is guaranteed. What are bio-dollars?

What the interviewer is looking for

Answer points

What is CMC, and why do drugs sometimes get rejected over ‘manufacturing issues’?

What the interviewer is looking for

Answer points

How can a one-time gene therapy priced at $3.95M be justified?

What’s the difference between a surrogate endpoint (like PFS) and overall survival (OS), and why does it matter?

The FDA approved a drug despite a negative advisory committee vote. How would you read that?

How does an antisense oligonucleotide (ASO) therapy work?

A patient death is reported in an ongoing trial. How should the clinical team respond?

Brief your leadership on the Hanmi–Roche obesity deal (up to $2.5B) in one paragraph.

How do vector safety issues in gene therapy affect approval?

Is it better to go head-to-head with Keytruda, or to combine with it?

How does a personalised mRNA cancer vaccine work?

Glass particles are found in one batch of an approved biosimilar. As the quality lead, what do you do first?

How is a molecular glue (targeted protein degradation) different from a traditional inhibitor?

How is a favourable FDA advisory committee vote different from final approval?

Do you agree that the edge in AI drug discovery is shifting from ‘compute’ to ‘data’?

What’s the difference between single GLP-1, dual GLP-1/GIP and triple agonist obesity drugs?

What are the pros and cons of building a supply chain before approval (e.g. Merck’s alimatravir)?

What is an FDA complete response letter (CRL), and how does publishing them affect companies?

A drug missed its primary endpoint in Phase 2, but the company decided to go to Phase 3. How would you judge that decision?

A new drug with proven efficacy is off to a slow first month of prescriptions. What are the likely causes, and what would you do?

Explain an ADC (antibody-drug conjugate) to someone without a science background.

What is the patent cliff, and how does Big Pharma respond to it?

You see a headline: ‘AI drug deal worth up to $600M.’ What do you check first?

China’s NMPA approved the world’s first solid-tumour CAR-T. Does that mean global approval?

If in vivo CAR-T is commercialised, how would CAR-T manufacturing and supply change?

How is a biosimilar different from a small-molecule generic, and why does being the first entrant matter?

If you had to invest in one of biosimilars, bispecifics or a first-in-class new target, which would you choose and why?

Explain the logic behind Big Pharma paying a 40% acquisition premium.

In an obesity market dominated by Novo and Lilly, how can a latecomer differentiate?

A biotech with no revenue and no product saw its stock jump 60% just from a name change. How would you judge its value?

When a Phase 3 result is reported, what do the hazard ratio and the p-value each tell you?

Compare ex vivo and in vivo approaches to gene therapy.

Why was KRAS ‘undruggable’ for 30 years, and how has a recent drug got around it?