NewDirector, Clinical Operations, Oncology 3316 Takeda Development Center AmericasDirector, Clinical Operations, OncologyMassachusettsOversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees; accountable for operational risk management strategy in collaboration with Strategic Partners. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Clinical Operations Lead Integrated Resources, IncClinical Operations LeadCambridge, MassachusettsContractorSecures operational excellence and delivery for one or more clinical studies by: • Developing operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country Lead • Overseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRO • Driving performance, quality, timelines and relationships through the CRO partnership model • Chairs the [Study Management Team] in partnership with the CRO study Lead of the [Study Management Team]; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues. Strives for effective, consistent, efficient and compliant processes by: • Championing best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group • Seeks interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phase • Follows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model • Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership model.
Senior Project Manager, Clinical Operations Bicara Therapeutics IncSenior Project Manager, Clinical OperationsBoston, MAFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Ability to work independently and successfully in a fast-paced, results-driven, highly accountable environment with large potential impact; ability to prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively.
Senior Director, Global Head of Clinical Operations Olympus CorpSenior Director, Global Head of Clinical OperationsWestborough, MAThe Sr Director, Global Head of Clinical Operations reports directly to the Global Head of Clinical Research and collaborates closely with the MSA leadership team to provide strategic leadership and direction for the clinical operations team including the oversight of all aspects of clinical studies in support of clinical evidence generation strategies across global business unit portfolios. The individual is a critical member of Clinical Affairs leadership team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across the global business units, and within the broader Olympus organization, as appropriate.
Director, Clinical Operations WhoopDirector, Clinical OperationsBoston, MassachusettsLead operational oversight of CROs, technology vendors, recruitment partners, and other external service providers, establishing scalable governance frameworks, performance metrics, and escalation pathways to ensure high-quality delivery and accountability. Oversee Clinical Data Management and clinical trial technologies, ensuring high-quality, timely, and compliant data collection, management, and delivery across systems including EDC, CTMS, eConsent, ePRO, eTMF, and remote study platforms.
Senior Director, Clinical Operations ArtbioSenior Director, Clinical OperationsCambridge, MassachusettsThe Senior Director of Clinical Operations collaborates closely with cross-functional teams, including clinical development, project management, regulatory, quality, finance, and translational and discovery research, to drive the successful execution of clinical study plans. Oversee study operational plans and execution from concept through close out and CSR writing, including site and vendor selection, data management, pharmacovigilance operations, imaging and laboratory assessments, and regulatory activities.
Associate Director Clinical Operations Vor BioPharma IncAssociate Director Clinical OperationsBoston, MA$195,000–$220,000 / yearThe ideal candidate will initiate and lead clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. The Associate Director will also work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure the successful execution of assigned projects.
Senior Project Manager, Clinical Operations Bicara TherapeuticsSenior Project Manager, Clinical OperationsBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Ability to work independently and successfully in a fast-paced, results-driven, highly accountable environment with large potential impact; ability to prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively.
Senior Director, Clinical Operations Kymera TherapeuticsSenior Director, Clinical OperationsWatertown, MA$235,000–$330,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Accountable for robust operational strategies for all studies in the Phase 3 program, ensuring consistency as needed, including country and site mix, PR&R and Site Engagement strategies, vendor strategy, risk based and site monitoring strategies, etc.
Clinical operations Lead Integrated Resources, IncClinical operations LeadCambridge, MassachusettsContractor2. Support operational excellence and delivery for one or more clinical studies by: • Managing the study operational strategy (SOS) with guidance from the lead COL or COS • Providing input to operational strategy (including ancillary vendors) aligned with the program strategy and working closely with the Clinical Country Lead (CCL) to set the country strategy, incorporating country input through the primary COL and study CCL • Overseeing the tactical execution of the operational strategy by the partner CRO; effectively providing oversight of the CRO, including close monitoring of CRO work on established baseline plans, highlighting areas in need of focus to assure issues are raised and resolved so baselines can be achieved • Utilizing operational expertise and scientific assessment to evaluate study feasibility: assess end point measurement options, and ensure the successful execution of study(ies). • Overseeing delivery of the study to budget 3. Strives for effective, consistent, efficient and compliant processes by: • Participating in best practice development in Phase planning and seeking opportunities for innovation and efficiency with the Clinical Study Leadership group • Following established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model; provides feedback via appropriate channels for opportunities to improve processes or set best practices (i.e. PON) • Embodying a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model.
Clinical Operations Manager Tessera TherapeuticsClinical Operations ManagerSomerville, MA$164,000–$199,000 / yearYou have previously demonstrated ability to partner with and proactively manage internal stakeholders, CROs, and vendors, and collaborate cross-functionally to deliver global clinical trials according to the planned timelines and budget, while ensuring quality in accordance with ICH-GCP guidelines and regulatory requirements. Bachelor's degree in a relevant scientific or healthcare discipline, with 8+ years of clinical operations experience, including 4+ years as a clinical trial manager, leading cross-functional teams and accountable for planning and executing global clinical trials.
Director, Clinical Operations Excellence Relay Therapeutics IncDirector, Clinical Operations ExcellenceCambridge, MA$163,000–$233,000 / yearIn a lean, matrixed biotechnology environment, this role will serve as both a strategic leader and hands-on contributor, partnering with study teams, functional stakeholders, CROs, and vendors to strengthen execution, simplify processes, develop actionable operational metrics and analytics, and proactively manage operational and quality risks. Vendor Oversight and Governance: Support execution of the vendor governance strategy by organizing and facilitating governance forums, tracking decisions and actions, supporting performance oversight, issue escalation, corrective action follow-up, quality trend review, and RBQM operationalization.
Clinical Operations Manager Tessera Therapeutics IncClinical Operations ManagerSomerville, MA$164,000–$199,000 / yearYou have previously demonstrated ability to partner with and proactively manage internal stakeholders, CROs, and vendors, and collaborate cross-functionally to deliver global clinical trials according to the planned timelines and budget, while ensuring quality in accordance with ICH-GCP guidelines and regulatory requirements. Bachelor's degree in a relevant scientific or healthcare discipline, with 8+ years of clinical operations experience, including 4+ years as a clinical trial manager, leading cross-functional teams and accountable for planning and executing global clinical trials.
Clinical Operations Manager Verily Life Sciences LLCClinical Operations ManagerBoston, MAThe Clinical Operations Manager owns critical study documentation, risk management strategy, site selection and qualification, monitoring oversight, and safety/deviation workflows from study start-up through to study close-out, collaborating within cross-functional teams to drive successful end-to-end study execution. Serve as the primary contact for clinical sites, managing site operations, protocol deviations, adverse event evaluations, and IRB reporting; and, oversees electronic Trial Master Files (eTMFs) to ensure full GCP compliance, regulatory adherence, and continuous audit readiness.
Director, Clinical Operations Excellence Relay Therapeutics, Inc.Director, Clinical Operations ExcellenceCambridge, MA$163,000–$233,000 / yearIn a lean, matrixed biotechnology environment, this role will serve as both a strategic leader and hands-on contributor, partnering with study teams, functional stakeholders, CROs, and vendors to strengthen execution, simplify processes, develop actionable operational metrics and analytics, and proactively manage operational and quality risks. Vendor Oversight and Governance: Support execution of the vendor governance strategy by organizing and facilitating governance forums, tracking decisions and actions, supporting performance oversight, issue escalation, corrective action follow-up, quality trend review, and RBQM operationalization.
Director, Clinical Operations Whoop IncDirector, Clinical OperationsBoston, MA$210,000–$230,000 / yearLead operational oversight of CROs, technology vendors, recruitment partners, and other external service providers, establishing scalable governance frameworks, performance metrics, and escalation pathways to ensure high-quality delivery and accountability. Oversee Clinical Data Management and clinical trial technologies, ensuring high-quality, timely, and compliant data collection, management, and delivery across systems including EDC, CTMS, eConsent, ePRO, eTMF, and remote study platforms.
Associate Director, Clinical Operations Kymera TherapeuticsAssociate Director, Clinical OperationsWatertown, MA$160,000–$240,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
Senior Director, Clinical Operations Kymera Therapeutics IncSenior Director, Clinical OperationsWatertown, MA$235,000–$330,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. How you'll make an impact: The Senior Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for the Phase 3 program of a high priority immunology program, KT-621.
Director, Clinical Operations Excellence Relay TherapeuticsDirector, Clinical Operations ExcellenceCambridge, MA$163,000–$233,000 / yearIn a lean, matrixed biotechnology environment, this role will serve as both a strategic leader and hands-on contributor, partnering with study teams, functional stakeholders, CROs, and vendors to strengthen execution, simplify processes, develop actionable operational metrics and analytics, and proactively manage operational and quality risks. Vendor Oversight and Governance: Support execution of the vendor governance strategy by organizing and facilitating governance forums, tracking decisions and actions, supporting performance oversight, issue escalation, corrective action follow-up, quality trend review, and RBQM operationalization.
Director, Clinical Operations Oruka Therapeutics, Inc.Director, Clinical OperationsWaltham, MA$213,000–$240,000 / yearSignificant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities. Role Overview: We are seeking an exceptionally nimble and flexible Director of Clinical Operations who has a track record of achievement across all aspects of trial setup and execution in a fast paced small biotech with limited infrastructure and resources.