Senior Director, Clinical Operations

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

The Senior Director ,Clinical Operationswillprovidestrategicandoperationalleadershipfortheplanningandexecutionofassignedearly-stageclinicaldevelopmentprogramsacross

Aditum

Bio'sportfolioofbiotechnologycompanies.

ReportingtotheSVP,Clinical Development Operations ,thisindividualwillindependentlyleadtheclinicaloperationsstrategyandexecutionforassignedprogramsspanningclinicalpharmacologystudies(first-in-human,SAD/MAD,PK/PD,drug-drug interaction) andPhaseI/IIpatientstudies,partneringcloselywithportfoliocompanyleadershipandcross-functionalteamstodeliverhigh-qualityclinicaltrialsontimeandwithinbudget.

The Senior Directorwillplayacriticalroleinbuildingscalableoperationalcapabilitiesacrosstheportfolio ,overseeingCROandvendorperformance,mentoringclinicaloperationsstaff,andhelpingestablishbestpracticesacrosstheportfolio.

Thisrolerequiresacollaborativeleaderwhoisequallycomfortableservingasprogramleadand,whereportfolioneedsrequireit,asthestudylead,developingoperationalstrategyandrollinguptheirsleevesinalean,fast-pacedbiotechincubatorenvironment.

Position Responsibilities

Program Leadership

• Leadclinicaloperationsformultipleearlydevelopmentprograms(clinicalpharmacologyandPhaseI/II) across
  
  Aditum
  
  Bio'sportfoliocompanies.
• Developoperationalstrategyalignedwithprogramandportfoliopriorities,buildingandpressure-testingscenarioplansacrosstimeline,cost,enrollment,andrisktoinformprogram-and portfolio-level decisions.

Study Execution

• Leadstudiesfromprotocoldevelopmentthroughcloseout,drivingglobaloperationalstrategy,feasibility,enrollment planning,andriskmitigation.
• Ensurestudiesaredeliveredontime,within budget,andtothehighestqualitystandards.
• Leadcross-functionalstudyteamsandowntheCROandvendorlifecycle(e.g.,selection,contract scope,oversight,andongoingperformance) thatdriveexecution.
• Overseestudytimelines,budgets,forecasts,resources,andvendorperformance.
• EnsurecompliancewithICH-GCPandapplicableglobalregulationswhilemaintaininginspectionreadiness.
• Drivecontinuousimprovementthroughscalableprocesses,SOPs,andoperationalbestpractices.
• Developandmentorclinicaloperationsstaffandexternalresourcesthroughdirectormatrixleadership.
• Championinnovativeapproachestotrialexecution,includingdigitaltechnologies,decentralized trials,andAI-enabledoperationalanalytics.

Qualifications

• Bachelor'sdegreeinascientificdiscipline;advanceddegreepreferred.
• Atleast
  10yearsofprogressiveclinicaloperationsexperiencewithinbiotechnology,pharmaceutical,orCROorganizations,includingleadershipresponsibilityforearly-stageclinicalprograms.
• Demonstratedsuccessleadingtheoperationalexecutionofbothclinicalpharmacologystudies(first-in-human,SAD/MAD,PK/PD,drug-drug interaction,food effect) andPhaseI/IIpatientstudies,includingglobalandmulti-center trials,withaclearemphasisonearlydevelopment.
• SignificantexperienceoverseeingCROsandexternalvendors,including governance,performance management,quality oversight,andbudgetaccountability.
• Strongunderstandingofclinicaldevelopmentstrategyandtheoperationalconsiderationsassociatedwithearly-stagedrugdevelopment.
• Hands-onexperiencewithglobaloperationalstrategy:countryandsiteselection,feasibility assessment,enrollment modeling,andscenarioplanningtosupportprogram-level decision-making.
• Provenabili…