Clinical Development interview prep.

Behavioural questions to expect

1. Walk me through your background + drug development experience.
2. Tell me about a clinical development program you've led or contributed to.
3. Why pharma + clinical development vs clinical practice or academia?
4. Why this therapeutic area?
5. Why the firm?
6. What's your read on our pipeline + portfolio?
7. Tell me what you understand about our regulatory + lifecycle strategy.
8. Walk me through a trial you designed (or would design) for a specific asset.

Technical concepts to master

• Target Product Profile (TPP) + Clinical Development Plan (CDP)

  Target Product Profile (TPP) · Clinical Development Plan (CDP) · Risk-benefit assessment · Lifecycle management

• Endpoint + biostats literacy

  Primary + secondary endpoints · ITT vs PP analysis · Alpha + power + sample size · Interim analysis + IDMC · Bayesian + adaptive designs

• Regulatory strategy + accelerated paths

  Fast Track designation · Breakthrough Therapy Designation · Accelerated Approval · Priority Review + Orphan Drug · EMA + global regulatory differences

• Matrix org + asset team

  Asset team / Global Program Team (GPT) · Functional vs matrix accountability · Decision gates + governance · Cross-functional alignment

Practical drills

• You're the medical lead for an investigational drug in a chronic disease (your choice of TA). Phase 2b showed a modest improvement on a surrogate endpoint vs placebo. Design the Phase 3 program - endpoints, design, sample size logic, regulatory path.
• Phase 2 data just read out. Primary endpoint missed by 15% on point estimate, p=0.08. Safety acceptable, biomarker signal in subgroup. Competitor's Phase 3 just succeeded. Walk through your recommendation to the governance committee.
• Your asset shows compelling Phase 2 efficacy in a serious unmet-need indication. Walk through your regulatory strategy - which path, when to engage FDA, what to prepare.

Smart-question anchors

• Pipeline + portfolio - TA mix, stage distribution, recent regulatory events
• Org + matrix structure - asset team composition, governance, decision gates
• Comp + career path - associate director / director / senior director / VP track
• R&D culture - scientific vs commercial weight, decision discipline, dissent culture
• External engagement - KOL + investigator relationships, conferences, publications

Sourced from

FDA Drug Development + Approval Process documents · EMA + ICH Guidelines (E6 GCP, E9 statistical principles, E11 paediatric) · BIO + PhRMA industry reports + clinical development efficiency analyses · ICH-GCP E6(R3) + Clinical Trial Transformation Initiative best practices · Friends of Cancer Research + Tufts CSDD drug development resources