Walk me through your background + drug development experience.

What it tests: Story arc - clinical + scientific training, drug development exposure, matrix experience.

Tell me about a clinical development program you've led or contributed to.

What it tests: Drug-development thinking - strategy, design, execution, decision-making.

What it tests: Authentic alignment - scale of impact, drug-development discipline, asset thinking, regulatory + commercial dimension.

What it tests: Specificity. Generic answers fail.

What it tests: Real homework - pipeline, TA, culture - not name-drop.

What it tests: Industry literacy - pipeline stage, competitive position, recent events.

What it tests: Regulatory fluency on this firm's approval pathway, LOE, label expansion, biosimilar response.

What it tests: Trial design thinking - TPP, endpoints, statistical + regulatory considerations, operational feasibility.

Medical directors (MD / DO + clinical research experience), clinical scientists (PhD or MD-PhD), clinical operations leads, biostatisticians.

Can the candidate think strategically about drug development - target product profile + clinical development plan + lifecycle?
Do they have regulatory fluency - FDA / EMA pathways, key meetings (pre-IND, EOP2, type B), accelerated programs?
Are they biostatistically literate - endpoints, power, alpha, interim analysis, multiplicity, futility?
Can they design a trial that answers the regulatory + commercial question + the scientific question?
Do they show matrix leadership - influence without authority across R&D, clin ops, stats, reg, med affairs, commercial?
Are they commercially aware - reimbursement, payer + HEOR + access, competitive landscape?
Can they navigate scientific + commercial trade-offs - when do you stop, accelerate, pivot?

Walk me through your background + drug development experience.
What it tests: Story arc - clinical + scientific training, drug development exposure, matrix experience.
Tell me about a clinical development program you've led or contributed to.
What it tests: Drug-development thinking - strategy, design, execution, decision-making.
Why pharma + clinical development vs clinical practice or academia?
What it tests: Authentic alignment - scale of impact, drug-development discipline, asset thinking, regulatory + commercial dimension.
Why this therapeutic area?
What it tests: Specificity. Generic answers fail.
Why this firm?
What it tests: Real homework - pipeline, TA, culture - not name-drop.
What's your read on our pipeline + portfolio?
What it tests: Industry literacy - pipeline stage, competitive position, recent events.
Tell me what you understand about our regulatory + lifecycle strategy.
What it tests: Regulatory fluency on this firm's approval pathway, LOE, label expansion, biosimilar response.
Walk me through a trial you designed (or would design) for a specific asset.
What it tests: Trial design thinking - TPP, endpoints, statistical + regulatory considerations, operational feasibility.

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

Target Product Profile (TPP): Document defining intended product characteristics - indication, population, efficacy claim, safety, route + dosing, label aspirations.
Clinical Development Plan (CDP): Strategic plan of clinical studies needed to achieve TPP - phase-by-phase trials + timelines + endpoints.
Risk-benefit assessment: Quantitative + qualitative analysis of efficacy vs safety + tolerability + alternatives.
Lifecycle management: Plan for asset value beyond first approval - label expansion, new indications, geographies, formulations, combinations.

Endpoint + biostats literacy

Primary + secondary endpoints: Primary = pivotal regulatory + statistical endpoint; secondary = supporting + label claims.
ITT vs PP analysis: Intent-to-treat (analyze as randomised) preserves randomisation + is regulatory standard; per-protocol (analyse only compliant subjects) may inflate effect.
Alpha + power + sample size: Alpha = type-I error tolerance (typically 0.025 one-sided / 0.05 two-sided); power = 1 - beta (typically 80-90%); sample size derives from effect + variance + alpha + power.
Interim analysis + IDMC: Pre-planned data look at predefined timepoint - by Independent Data Monitoring Committee.

Regulatory strategy + accelerated paths

Fast Track designation: FDA designation for serious condition + unmet need - enables frequent FDA interaction + rolling submission.
Breakthrough Therapy Designation: FDA designation when preliminary data suggest substantial improvement over existing treatments.
Accelerated Approval: Approval based on surrogate endpoint reasonably likely to predict benefit - with required confirmatory trials.
Priority Review + Orphan Drug: Priority Review = 6-month vs 10-month FDA review; Orphan Drug = 7-yr exclusivity + tax credits for rare disease.

Matrix org + asset team

Asset team / Global Program Team (GPT): Cross-functional team owning asset strategy - includes Medical, Stats, Reg, Clin Ops, CMC, Med Affairs, Commercial.
Functional vs matrix accountability: Functional manager (Medical, Stats etc.) owns career + competency; matrix leader (Asset Lead) owns deliverables.
Decision gates + governance: Stage-gated reviews (e.g. portfolio review, development decision, commit-to-pivotal) where asset progression is approved.
Cross-functional alignment: The daily work - aligning Medical, Stats, Reg, Commercial, Med Affairs on TPP, design, messaging.

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.

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

Drop your CV and a job description on the home page. A couple of minutes later you get a report with everything you need to land the job.