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Job description
Cambridge, Massachusetts or Oakland California
At Aditum Bio, our mission is to rapidly translate scientific discoveries into new medicines. Cofounded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies that for some reason are not advancing toward the clinic. The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need.
Position Summary
TheSeniorDirector,ClinicalOperationswillprovidestrategicandoperationalleadershipfortheplanningandexecutionofassignedearly-stageclinicaldevelopmentprogramsacrossAditumBio'sportfolioofbiotechnologycompanies.ReportingtotheSVP,ClinicalDevelopmentOperations,thisindividualwillindependentlyleadtheclinicaloperationsstrategyandexecutionforassignedprogramsspanningclinicalpharmacologystudies(first-in-human,SAD/MAD,PK/PD,drug-druginteraction)andPhaseI/IIpatientstudies,partneringcloselywithportfoliocompanyleadershipandcross-functionalteamstodeliverhigh-qualityclinicaltrialsontimeandwithinbudget.TheSeniorDirectorwillplayacriticalroleinbuildingscalableoperationalcapabilitiesacrosstheportfolio,overseeingCROandvendorperformance,mentoringclinicaloperationsstaff,andhelpingestablishbestpracticesacrosstheportfolio.Thisrolerequiresacollaborativeleaderwhoisequallycomfortableservingasprogramleadand,whereportfolioneedsrequireit,asthestudylead,developingoperationalstrategyandrollinguptheirsleevesinalean,fast-pacedbiotechincubatorenvironment.
Position Responsibilities
ProgramLeadership
Leadclinicaloperationsformultipleearlydevelopmentprograms(clinicalpharmacologyandPhaseI/II)acrossAditumBio'sportfoliocompanies.
Developoperationalstrategyalignedwithprogramandportfoliopriorities,buildingandpressure-testingscenarioplansacrosstimeline,cost,enrollment,andrisktoinformprogram-andportfolio-leveldecisions.
StudyExecution
Leadstudiesfromprotocoldevelopmentthroughcloseout,drivingglobaloperationalstrategy,feasibility,enrollmentplanning,andriskmitigation.
Ensurestudiesaredeliveredontime,withinbudget,andtothehighestqualitystandards.
Leadcross-functionalstudyteamsandowntheCROandvendorlifecycle(e.g.,selection,contractscope,oversight,andongoingperformance)thatdriveexecution.
Overseestudytimelines,budgets,forecasts,resources,andvendorperformance.
EnsurecompliancewithICH-GCPandapplicableglobalregulationswhilemaintaininginspectionreadiness.
Drivecontinuousimprovementthroughscalableprocesses,SOPs,andoperationalbestpractices.
Developandmentorclinicaloperationsstaffandexternalresourcesthroughdirectormatrixleadership.
Championinnovativeapproachestotrialexecution,includingdigitaltechnologies,decentralizedtrials,andAI-enabledoperationalanalytics.
Qualifications
Bachelor'sdegreeinascientificdiscipline;advanceddegreepreferred.
Atleast10yearsofprogressiveclinicaloperationsexperiencewithinbiotechnology,pharmaceutical,orCROorganizations,includingleadershipresponsibilityforearly-stageclinicalprograms.
Demonstratedsuccessleadingtheoperationalexecutionofbothclinicalpharmacologystudies(first-in-human,SAD/MAD,PK/PD,drug-druginteraction,foodeffect)andPhaseI/IIpatientstudies,includingglobalandmulti-centertrials,withaclearemphasisonearlydevelopment.
SignificantexperienceoverseeingCROsandexternalvendors,includinggovernance,performancemanagement,qualityoversight,andbudgetaccountability.
Strongunderstandingofclinicaldevelopmentstrategyandtheoperationalconsiderationsassociatedwithearly-stagedrugdevelopment.
Hands-onexperiencewithglobaloperationalstrategy:countryandsiteselection,feasibilityassessment,enrollmentmodeling,andscenarioplanningtosupportprogram-leveldecision-making.
Provenabilitytoleadmultipleconcurrentclinicalprogramswhileeffectivelybalancingcompetingprioritiesinafast-pacedenvironment.
DeepknowledgeofICH-GCP,FDA,EMA,andotherapplicableregulatoryrequirementsgoverningclinicalresearch.
Experiencemanagingclinicaltrialbudgets,resourceplanning,forecasting,andoperationalriskmanagement.
DemonstratedsuccessbuildingcollaborativerelationshipsacrossClinicalDevelopment,Biometrics,Regulatory,Quality,andexecutiveleadership.
Excellentleadership,communication,andnegotiationskills,withprovenabilitytoinfluenceandalignseniorstakeholders,includingportfoliocompanyexecutives,CMOs,investigators,andCROpartners,withoutdirectauthority.
Trackrecordofintroducingnewtechnologies,tools,orwaysofworkingwithinclinicaloperations,andofleadingthechangemanagementrequiredforadoption.
Comfortableoperatinginaleanbiotechincubatormodelwherestrategicleadershipispairedwithahands-on,execution-focusedapproach,includingthewillingnesstoserveasbothprogramleadandstudyleadasportfolioneedsdictate.
The range for this full-time position is $275,000 - 285,000, plus a target bonus, equity compensation and benefits including medical, dental, vision, and 401k. Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job-related skills, experience and relevant education and training. Please note the range reflects base salary and does not include target bonus, equity or benefits.
We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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Worksite address
oakland, CA, 94616, US
Who can apply
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