Director, Clinical Development (SaMD) — Diagnostics + Medical Device

Bios Life; Cambridge (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Bios Life is seeking a Director of Clinical Development to lead the clinical strategy and evidence generation for SaMD portfolio in a regulated environment.

You will own the lifecycle of clinical evidence from validation to post-market surveillance, integrating AI/ML-driven software into compliant healthcare solutions.

Qualifications

• 6+ years in clinical development, clinical affairs, or clinical operations.
• Direct SaMD (AI/ML-enabled) clinical development experience required.
• Experience supporting FDA/EU MDR/IVDR clinical requirements for software-based products.
• Proven leadership of multi-site clinical validation studies from protocol design to CSR.
• Familiarity with ICH-GCP, ISO13485, ISO14155, IEC62304, and SaMD guidance.

Responsibilities

• Own the clinical development strategy for SaMD products aligned to FDA SaMD framework and ML practices.
• Design and lead clinical validation studies establishing analytical and clinical validity.
• Lead real-world evidence programs and post-market surveillance for deployed software.
• Oversee study execution, CRO/vendor management, data integrity, and safety reporting.
• Collaborate with Regulatory, Quality, Data Science, and Product teams to drive evidence generation.

Skills

Clinical study leadership

Regulatory fluency

GCP/ISO standards knowledge

Cross-functional leadership

Education

Advanced degree (PhD/MD/PharmD/MS or equivalent)

Job description

BiosLifeisatechnology-enabledhealthcarecompanybuilttoempowerindividualstoproactivelymanagetheircancerrisk,redefiningpersonalizedcancerscreeningandsurvivorship.

Surveillanceforpeopleathighriskofcancerandforcancersurvivorsistoooftengeneric,fragmented,andreactive.Screeningfollowspopulationaveragesratherthanindividualrisk.Data,expertise,andcaredeliverysitapartfromoneanother,andcaretendstowaitforaproblemtoappearbeforeresponding.

BiosLifeisbuildingtheoperatingsystemforpersonalizedcancersurveillance:aplatformthatreadsgenomic,clinical,laboratory,andlifestyledatatogether,modelshowanindividual’sriskchangesovertime,andintegratesthatintelligencewithacontinuouslycuratedevidencebase–alldeliveredbyaclinician-ledcareteamspecializedincancersurveillance.

Weoffertwoprograms:

PersonalizedScreening—anintegratedpan-cancerscreeningprogrambuiltaroundanindividual’sriskprofile.

Survivorship—continuoussurveillanceandholisticcaredesignedaroundthespecificneedsofcancersurvivors.

Ourteampairsdecadesofexperienceattheforefrontofinnovativecancercarewithdeepexpertiseingenomicsandmachinelearning,supportedbyinternationallyrecognizedadvisorswhohavehelpedshapescreeningandsurvivorshipguidelines.

AbouttheRole

WeareseekingaDirector,ClinicalDevelopmenttoleadtheclinicalstrategyandevidencegenerationbehindourSoftwareasaMedicalDevice(SaMD)portfolio—algorithm-driven,AI/ML-enableddiagnosticanddevicesoftwareoperatinginafullyregulatedenvironment(FDA,ISO13485/14155,IEC62304,EUMDR/IVDR).

Thisleaderownstheclinicalevidencelifecycleforsoftware-basedproducts:frompre-marketclinicalvalidationofalgorithmsthroughreal-worldevidence(RWE)generation,post-marketperformancemonitoring,andcontinuousalgorithmsurveillance.Thisisaroleforaclinicaldevelopmentleaderwhounderstandswhatittakestovalidatesoftware—notjusthardwareorassays—andtosustainthatevidenceasmodelsevolveinthefield.

Youwillsitattheintersectionofclinicalscience,regulatorystrategy(includingFDA’sSaMD/AI-MLactionplanandPredeterminedChangeControlframeworks),datascience,andproductdevelopment.

KeyResponsibilities

SaMDClinicalStrategy&Validation

• OwntheclinicaldevelopmentstrategyforSaMDproducts,alignedtoFDA’sSaMDframework,GoodMachineLearningPractice(GMLP),andapplicableinternationalstandards.
• Designandleadclinicalvalidationstudiesthatestablishtheanalyticalandclinicalvalidityofalgorithm/AI-drivendiagnosticanddevicesoftware.
• Defineclinicalevidencerequirementsformodelperformance,generalizability,andsubgroup/biasanalyses.

Real-WorldEvidence&Post-MarketPerformance(differentiatingstrength)

• Designandexecutereal-worldevidence(RWE)programs—prospectiveregistries,retrospectivereal-worlddata(RWD)studies,andpost-marketperformancemonitoringfordeployedsoftware.
• EstablishcontinuousperformancesurveillanceforAI/MLmodelsinthefield,supportingpredeterminedchangecontrolplans(PCCP)andalgorithmupdateevidence.
• LeverageRWD/RWEforlabelexpansion,reimbursement/health-economicssupport,andregulatorylifecyclemaintenance.

StudyExecution&Operations

• Leadend-to-endstudyexecution:siteselection,start-up,enrollment,monitoring,datalock,close-out,andclinicalstudyreports(CSRs).
• ManageCROs,datapartners,real-worlddatasources,corelabs,andclinicalsites—includingbudgets,timelines,andqualityoversight.
• Overseeclinicaldataintegrity,safetyreporting,andaudit/inspectionreadiness.

Regulatory&EvidenceGeneration

• PartnerwithRegulatoryAffairsonFDAsubmissions(510(k),DeNovo,PMA,IDE,Q-sub/pre-sub)andinternationalfilings(EUMDR/IVDR,CEmark)forsoftware-basedproducts.
• Authorandreviewclinicalevaluationplans/reports(CEP/CER),clinicalvalidationprotocols,PMCF/PMPFplans,andRWEstudydesigns.
• EnsurecompliancewithICH-GCP,ISO14155,IEC62304,21CFR812/820,ISO14971,andSaMD-specificguidance.

Cross-FunctionalLeadership

• Serveastheclinicalvoiceoncross-functionalteams(DataScience/ML,R&D,Regulatory,Quality,Product,Commercial).
• EngageKOLs,investigators,ClinicalEventsCommittees(CECs),andDataSafetyMonitoringBoards(DSMBs);representclinicalandreal-worldevidencetointernalleadership,regulators,andexternalstakeholders.
• Buildandmaintainstrategicrelationshipswithleadingacademicinstitutions,clinicalinvestigators,andindustrypartnerstosupportclinicaldevelopmentinitiatives,collaborativeresearch,andevidencegeneration.
• Contributetoscientificpublicationsinpeer-reviewedjournalsandrepresentthecompanyatmajormedical,scientific,andclinicalconferencesthroughpresentations,panels,andotherthoughtleadershipactivities.
• Mentorand,overtime,buildaclinicaldevelopment/evidenceteam.

RequiredQualifications

• Level: 6+yearsinclinicaldevelopment,clinicalaffairs,orclinicaloperations.
• SaMD(required):DirectclinicaldevelopmentexperiencewithSoftwareasaMedicalDevice—AI/ML-enabled,algorithm-driven,ordigitaldiagnostic/devicesoftwareinaregulatedsetting.Candidateswhoseentirebackgroundishardware-onlyorassay-only,withnosoftware/algorithmclinicalvalidation,willnotqualify.
• Industry: Diagnostics/IVD,medicaldevice,ordigitalhealth,inaregulated(FDA/EUMDR/IVDR)environment.
• Regulatoryfluency: ExperiencesupportingFDA(510(k),DeNovo,PMA,IDE,pre-sub)and/orEUMDR/IVDRclinicalrequirementsforsoftware-basedproducts;familiaritywithFDA’sSaMD/AI-MLframework.
• Studyleadership: Proventrackrecordleadingmulti-siteclinicalvalidationstudiesfromprotocoldesignthroughCSR,includingCRO/vendorandsitemanagement.
• Standards: WorkingcommandofICH-GCP,ISO14155,ISO13485,ISO14971,and(preferred)IEC62304forsoftwarelifecycle.
• Education: Advanceddegree(PhD,MD,PharmD,MS,orequivalent)inalifesciences,clinical,datascience,orengineeringdisciplinepreferred.
• Location: BasedinorcommutabletoCambridge,MA.

PreferredQualifications

• Real-worldevidence(stronglypreferred):Hands-onexperiencedesigningandexecutingRWE/RWDprograms—registries,real-worldvalidation,post-marketperformancemonitoring,oralgorithmsurveillancefordeployedsoftware.
• Experienceworkingwithinoncologyisstronglypreferred.
• Experiencewithpredeterminedchangecontrolplans(PCCP)andevidenceforAI/MLmodelupdates.
• Exposuretocompaniondiagnostics(CDx),digitalpathology,imagingAI,clinicaldecisionsupport,orprecision-medicinesoftware.
• Reimbursement/health-economicsevidencegenerationandlabel-expansionstudies.
• Experienceatagrowth-stageorscalingorganizationbuildingclinical/RWEinfrastructureandprocesses.