Senior Director, Clinical Operations

Aditum Bio; Cambridge, Oakland (MA, CA); On-site; USD 275,000 - 285,000; Full time

Job summary

Aditum Bio is seeking a Senior Director, Clinical Operations to lead strategic and operational planning for assigned early-stage clinical development programs across its biotechnology portfolio.

Reporting to the SVP, Clinical Development Operations, this role will independently lead clinical operations strategy for first-in-human and Phase I/II studies, partnering with portfolio leadership and cross-functional teams to deliver trials on time and within budget.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• 10+ years progressive clinical operations experience within biotech/pharma/CROs including leadership responsibility for early-stage programs.
• Proven success leading operational execution of clinical pharmacology studies (FIH, SAD/MAD, PK/PD, DDI, food effect) and Phase I/II trials.
• Significant experience overseeing CROs and external vendors, including governance, performance management, quality oversight, and budget accountability.
• Strong understanding of clinical development strategy and operational considerations for early-stage drug development.

Responsibilities

• Lead clinical operations for multiple early-development programs across portfolio companies.
• Develop operational strategy aligned with program priorities, building scenario plans for timeline, cost, enrollment, and risk decisions.
• Lead studies from protocol development through closeout, driving global strategy, feasibility, enrollment planning, and risk mitigation.
• Ensure studies are delivered on time, within budget, and to high quality standards.
• Oversee CRO/vendor lifecycle including selection, scope, oversight, and ongoing performance; manage timelines, budgets, forecasts, resources.
• Ensure regulatory compliance (ICH-GCP, FDA, EMA) and inspection readiness.
• Drive continuous improvement via scalable processes, SOPs, and best practices.
• Mentor clinical operations staff and external resources; balance program leadership and study lead roles as needed.
• Champion innovative trial execution approaches, including digital technologies, decentralized trials, and AI-enabled analytics.

Skills

Leadership

Clinical Ops

Program Mgmt

Budget Mgmt

Regulatory

Education

Bachelor's in science

Advanced degree preferred

Tools

GxP Systems

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.