Study Director

Job Description Summary Responsible independently forthe execution and delivery of the GCO supported Radioligand Therapy(RLT) clinical studies of medium to highly complexity and of highpriority for Novartis, per the Operational Execution Plan (OEP) andclinical study protocol. The Study Director is the leader of thecross-functional clinical trial team (CTT), guides planning andmanagement of the assigned clinical study/studies end-to-end toachieve Global Program Team (GPT), Global Clinical Team (GCT), andGCO objectives. Accountable for proactive, iterative operationalplanning with effective contingencies and embedded risk managementmindset in CTT. Oversee budget and people allocation withinassigned study/studies. Identify area of improvements (process andtrainings), promotes operational excellence through processimprovement and knowledge sharing across studies. Fosters anempowered, psychologically safe organization that can navigate amatrix environment, learns, and adjusts quickly to changingconditions and business needs. This is a hybrid position with 12days per month from the office in White City, London. JobDescription Key responsibilities: * Leads independently theclinical trial team in collaboration with the Clinical OperationsProgram Head (COPH), delivery of multiple complex global studiesand promotes learning, sharing, consistent performance, andoperational excellence through an agile mindset, agile principles,and a team of teams model. * Acts as the CTT product owner withduties and responsibilities per established ways of working. *Guides planning and decision making at the study level and deliversassigned clinical study/studies per the Operational Execution Plan(OEP) and clinical study protocol. * Fosters an agile culturewithin assigned studies to achieve sprint goals and cycles,maximizing collaboration and minimizing dependencies in order toachieve long-term business impact. * In collaboration withregulatory writing and clinical development, promotes operationalexcellence in the development of global clinical study protocol(s),by translating the approved study concept sheet(s) into efficient,high quality, executable clinical protocols, and study-relateddocuments. * Creates effective CTT dynamics and achieves onperformance, prioritization, and communication in closecollaboration with CTT sub-team leaders. * Proactive riskmanagement and inspection readiness. * Responsible for developingclinical study timelines in collaboration with the ClinicalOperations Program Head (COPH), and overseeing assigned studybudgets. * Ensures systems are maintained with up-to-date studystatus, risks, and issues. * Fosters a close working relationshipwith the SSO Clinical Program Managers (CPMs) to strengthen therelationship between the global and local teams. * Oversees studyrecruitment and is responsible for activating mitigation strategiesin collaboration with the SSO Clinical Program Managers (CPMs). *Fosters a close working relationship with the VPG Vendor ProgramManagers (VPMs) to strengthen the relationship between the vendorsand CTT to deliver on clinical study objectives. * Fosters a closeworking relationship with the CDO Trial Data Scientist (TDS) todeliver on clinical study objectives. * Ensures proper handling ofall study close out activities including, but not limited to, siteclose out, final drug accountability, and audit readiness of TrialMaster File documentation. * Promotes operational excellence andcontributes to the development of Clinical Study Reports; reportingof clinical study results, and internal/external publications, whenappropriate. * Partners and collaborates with PSP/ClinicalOperations Program Head (COPH) to deliver clinical studies inalignment with program strategy. * Achieves excellence in studyoperations and management through process improvement incollaboration with the Head Study Leadership or the StudyLeadership Community Lead/Host (as applicable) and GCO Process,Training, and Compliance (PTC). * May deputize for the COPH as aleader and spokesperson for the CTT at Novartis internal meetings.Essential requirements: * Bachelor’s degree in lifesciences/healthcare (or clinically relevant degree) is required.Advanced degree is preferred. * ≥ 5 years’ experience inRadioligand Therapy (RLT) technology. * ≥ 7 years of recentinvolvement in clinical research or drug development in an academicor industry environment spanning clinical activities in Phases Ithrough IV studies of medium to highly complexity and of highpriority. * ≥ 3-5 years of recent contribution to andaccomplishment in all aspects of conducting clinical studies ofmedium to highly complexity and of high priority for Novartis(e.g., planning, executing, reporting, and publishing) in aglobal/matrix environment in pharmaceutical industry or a contractresearch organization, including expert knowledge of internationalstandards (GCP/ICH), health authorities (FDA/EMA), local/NationalHealth Authorities regulations. * Management of virtual teams.Proven ability and strong experience leading teams and buildingcapabilities. * Experience in developing effective workingrelationships with internal and external stakeholders. * Excellentcommunicator and presenter (oral and written); ability tocommunicate at all levels. * Outstanding organization andprioritization. * Excellent negotiation and conflict resolutionskills and enterprise mindset. * Strong project management skillsand demonstrated ability to meet timelines. * Proven track recordin study operations process improvement(s). * Superior strategicthinking with strong analytical and problem-solving skills. *Extensive knowledge of appropriate therapeutic area preferred. WhyNovartis? Our purpose is to reimagine medicine to improve andextend people’s lives and our vision is to become the most valuedand trusted medicines company in the world. How can we achievethis? With our people. It is our associates that drive us each dayto reach our ambitions. Be a part of this mission and join us!You’ll receive: You can find everything you need to know about ourbenefits and rewards in the Novartis Life Handbook. Commitment toDiversity and Inclusion: Novartis is committed to building anoutstanding, inclusive work environment and diverse teamsrepresentative of the patients and communities we serve. SkillsDesired: Budget Management, Clinical Research, Clinical Trials,Coaching, Cross-Functional Teams, Lifesciences, People Management,Risk Management, Risk Monitoring. J-18808-Ljbffr