ClinPharm PMx Skills · the job map
Coverage map · regenerated from the ledger
The clinical pharmacology job
167 tasks across 3 bands, 15 domains, and 64 sub-domains. Open a domain, then a sub-domain, to reach a task. Each task is coloured by whether a shipped skill actually carries it.
ClinPharm PMx Skills
53carried
114nothing built
167 tasks · 151 released packages · 0 built
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Band AFoundationsKnowledge and methods applied to everything below. Not ranked by frequency — this is substrate, not activity.636042
1 Scientific foundations 4220 26
1.1Drug disposition4
- ADME and routes of eliminationNothing built
- Metabolite profiling and MISTNothing built
- Enzyme and transporter biologyNothing built
- Protein binding and tissue distributionNothing built
1.2Exposure characterisation4
- Non-compartmental analysisSkill covers it
- Parameter plausibility and unit integrityNothing built
- Dose proportionality, accumulation, time dependencyNothing built
- Phase 0 and microdosing approachesNothing built
1.3Response characterisation3
- Pharmacodynamics and biomarkersNothing built
- Target engagementNothing built
- Exposure-response relationshipsNothing built
1.4Measurement science4
- Bioanalytical assays and validationSkill covers it
- Immunogenicity assaysNothing built
- Biomarker fit-for-purposeNothing built
- Multi-analyte strategies for ADCsSkill covers it
1.5Modality-specific pharmacology6
- Small moleculeNothing built
- Therapeutic protein and monoclonal antibodyNothing built
- Antibody-drug conjugateSkill covers it
- OligonucleotideNothing built
- Cell, gene and regenerativeNothing built
- Vaccine and radioligandNothing built
1.6Therapeutic-area pharmacology5
- OncologyNothing built
- Infectious disease - PTA and MIC target attainmentNothing built
- Rare disease and small-nNothing built
- Neuroscience and CNS penetrationNothing built
- Cardiometabolic and immunologyNothing built
2 Quantitative pharmacology 2140 16
2.1Pharmacometrics6
- Population PK and covariate modellingSkill covers it
- Exposure-response modellingNothing built
- Model-based meta-analysisNothing built
- Disease-progression modellingNothing built
- Model evaluation and diagnosticsNothing built
- Model analysis plan and report (MAP/MAR)Skill covers it
2.2Mechanistic and systems modelling3
- PBPK and biopharmaceutics modellingNothing built
- Quantitative systems pharmacologyNothing built
- Agent-based modelsNothing built
2.3Statistics for clinical pharmacology3
- Bioequivalence statistics - TOST and confidence intervalsNothing built
- Sample size and powerNothing built
- Multiplicity and inference in exposure-responseNothing built
2.4AI, machine learning and informatics4
- AI/ML methods in drug developmentNothing built
- Analysis dataset standards and provenanceNothing built
- CDISC PK domains (PC, PP) and define.xmlNothing built
- Computational environment and reproducibilityNothing built
Band BThe development arcSequential. Each domain fires at its own point in a programme's life.4155096
3 Evidence strategy 280 10
3.1Programme planning3
- Clinical pharmacology development planSkill covers it
- MIDD plan and model inventoryNothing built
- Target product profile inputsNothing built
3.2Evidence routing3
- Study versus model versus waiver decisionsNothing built
- Special-population strategySkill covers it
- Modality applicabilityNothing built
3.3External intelligence3
- Guidance surveillance and impact assessmentNothing built
- Regulatory precedent analysisNothing built
- Competitive landscapeNothing built
3.4Asset evaluation1
- Due diligence and in-licensingNothing built
4 Translation and first-in-human 350 8
4.1Human dose prediction2
- Nonclinical synthesis for human readinessNothing built
- Human PK prediction - allometry, IVIVE, PBPKSkill covers it
4.2Starting dose3
- NOAEL to HED to MRSDNothing built
- MABEL and pharmacologically active doseSkill covers it
- Safety margins against toxicology exposuresNothing built
4.3Escalation design2
- Escalation schema, sentinel and staggered dosingSkill covers it
- Exposure cap and stopping rulesNothing built
4.4Translational measurement1
- Biomarker and target-engagement strategyNothing built
5 Study delivery 1310 14
5.1Design4
- Study concept and objectivesSkill covers it
- Protocol clinical pharmacology sectionsSkill covers it
- PK/PD sampling scheduleSkill covers it
- Bioanalytical planSkill covers it
5.2Analysis specification2
- PK analysis plan and SAP contributionSkill covers it
- BLQ, actual-versus-nominal times, exclusion rulesSkill covers it
5.3Conduct oversight4
- Escalation and safety-committee data packagesSkill covers it
- Interim and blinded PK reviewSkill covers it
- Deviation and sampling-compliance impactSkill covers it
- Protocol amendment impactSkill covers it
5.4Analysis oversight2
- NCA oversight and dual-control QCSkill covers it
- Pharmacometrics deliverable review and sign-offSkill covers it
5.5Reporting2
- Topline interpretation and team readoutNothing built
- CSR PK sections and consistency QCSkill covers it
6 Characterisation studies 5120 17
6.1Interaction4
- In-vitro DDI packageSkill covers it
- Clinical DDI studiesSkill covers it
- DDI management strategySkill covers it
- Food effect and gastric pH / acid-reducing agentsNothing built
6.2Organ impairment3
- Renal impairmentNothing built
- Hepatic impairmentNothing built
- Dialysis and organ replacementNothing built
6.3Population factors6
- Age, sex and body sizeSkill covers it
- ObesityNothing built
- Pregnancy and lactationNothing built
- PaediatricNothing built
- PharmacogenomicsSkill covers it
- Ethnic sensitivity and ICH E5 bridgingNothing built
6.4Product factors2
- Biopharmaceutics, BA/BE and formulation bridgingNothing built
- Model-supported biowaiver justificationNothing built
6.5Cardiac and immune2
- QT and concentration-QTcNothing built
- Immunogenicity impact on PKNothing built
7 Dose and regimen decisions 380 11
7.1Dose finding2
- Dose-ranging design inputNothing built
- Oncology dose optimisationNothing built
7.2Exposure-response interpretation3
- For efficacyNothing built
- For safetyNothing built
- Clinical meaningfulness of covariate effectsNothing built
7.3Regimen construction4
- Fixed versus weight-based dosingNothing built
- Dose-modification schemeSkill covers it
- Paediatric dose selectionNothing built
- Therapeutic drug monitoring and precision dosingNothing built
7.4Justification2
- Registration dose justificationSkill covers it
- MIDD regulatory engagement packageSkill covers it
8 Regulatory evidence package 660 12
8.1Early submission2
- IND / CTA / IMPD clinical pharmacology contentSkill covers it
- Investigator's Brochure PK sectionSkill covers it
8.2Periodic reporting1
- DSUR and annual report contributionSkill covers it
8.3Application summaries5
- CTD 2.7.1 biopharmaceuticsNothing built
- CTD 2.7.2 clinical pharmacologySkill covers it
- CTD 2.5 clinical overviewNothing built
- CTD 2.7.3.4 and 2.7.4 exposure-safetySkill covers it
- CTD 2.7.6 study synopsesNothing built
8.4Submission mechanics3
- Module 5 placementNothing built
- Submission datasets and define.xmlNothing built
- Cross-document traceabilitySkill covers it
8.5Review-phase authoring1
- Assessment Aid applicant's positionNothing built
9 Agency engagement 430 7
9.1Meeting preparation3
- Meeting strategy and type selectionNothing built
- Briefing package contentSkill covers it
- Applicant's position authoringSkill covers it
9.2Meeting execution2
- Representation and position defenceNothing built
- Minutes and commitment captureSkill covers it
9.3Review-cycle response1
- Information-request and discipline-review responseSkill covers it
9.4Commitment negotiation1
- PMR/PMC wording, design and timetableNothing built
10 Product information 540 9
10.1US prescribing information4
- Section 12 pharmacologySkill covers it
- Section 2 dosing basisSkill covers it
- Section 7 interactionsSkill covers it
- Section 8 specific populationsNothing built
10.2Other regions3
- EU SmPC 4.2 / 4.5 / 5.2Skill covers it
- Japan package insert sections 9, 10 and 16Nothing built
- Company core data sheetNothing built
10.3Negotiation and maintenance2
- Labelling negotiation with the agencyNothing built
- Post-approval label updatesSkill covers it
11 Post-approval stewardship 080 8
11.1Change assessment2
- Post-approval change impactNothing built
- CMC change BA/BE assessmentNothing built
11.2Commitments1
- PMR/PMC execution and close-outNothing built
11.3Expansion2
- New indications and populationsNothing built
- Line extensions - routes, formulations, devicesNothing built
11.4Real-world evidence2
- Registry and real-world PKNothing built
- Drug utilisation and outcomesNothing built
11.5Evidence maintenance1
- Living dose-rationale threadNothing built
Band CCross-cutting obligationsApply at every stage of the development arc, not at one point in it.621229
12 Safety and risk interface 420 6
12.1Exposure-safety2
- Quantitative input to benefit-riskSkill covers it
- DILI and organ-toxicity exposure marginsSkill covers it
12.2Signal work2
- Signals with an exposure componentNothing built
- Safety-committee exposure inputSkill covers it
12.3Safety documentation2
- Reference safety information linkageSkill covers it
- Overdose and antidote guidanceNothing built
13 Participant protection and ethics 050 5
13.1Consent and privacy2
- Consent for PK and genetic samplingNothing built
- Privacy in PK and pharmacogenomic datasetsNothing built
13.2Participant safety2
- Vulnerable-population protectionNothing built
- Sentinel dosing and subject-safety designNothing built
13.3Oversight1
- Ethics-committee interaction on CP contentNothing built
14 Access and value 050 5
14.1Payer evidence2
- HTA and payer exposure evidenceNothing built
- Dose optimisation for cost and accessNothing built
14.2Competitive position2
- Label differentiationNothing built
- Biosimilar and generic defenceNothing built
14.3Global access1
- LMIC dosing and access considerationsNothing built
15 Function leadership and operations 292 13
15.1Governance4
- Decision packages and go/no-go inputNothing built
- Cross-functional representationOutside this product
- Portfolio review and timeline commitmentsNothing built
- Safety and escalation committee documentationSkill covers it
15.2External partners2
- CRO and vendor qualification and oversightNothing built
- Outsourcing scope, budget and deliverablesNothing built
15.3Quality system2
- SOPs, templates and knowledge assetsSkill covers it
- Inspection readiness and data integrityNothing built
15.4People1
- Hiring, mentoring and capability buildingOutside this product
15.5Scientific standing3
- Publications and congress presentationsNothing built
- External scientific engagementNothing built
- Applied regulatory science contributionNothing built
15.6Modernisation1
- AI/ML workflow automationNothing built