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.
Sr.Clinical Operations Lead Integrated Resources, IncSr.Clinical Operations LeadCambridge, MassachusettsFull timeWorks closely with key scientific leaders, CRO global lead, Vendor Management, Operation Lead, study or program MDs, Program Directors, Study Management Team members including Regulatory Affairs, Medical Affairs, Commercial, Discovery, and Analytical Development. 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.
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.
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.
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.
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.
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.
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.
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.
Senior Manager, Clinical Operations - FSP Resource & Vendor Management CSL Behring LLCSenior Manager, Clinical Operations - FSP Resource & Vendor ManagementWaltham, MA$170,000–$201,000 / yearThe Senior Manager, Clinical Operations FSP Resource & Vendor Management sits within the Clinical Operations organization and is accountable for the end‑to‑end oversight, planning, and optimization of FSP resources supporting Clinical Operations functions. The role serves as the primary Clinical Operations interface to FSP vendors and works in close partnership with the POE organization, which retains accountability for enterprise‑level contracting, sourcing strategy, and overall vendor governance.
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.
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.
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.
Global HR Business Partner - BioPharma R&D Clinical Operations AstraZeneca PlcGlobal HR Business Partner - BioPharma R&D Clinical OperationsBoston, MA$172,347.20–$258,520.80 / yearSignificant HR experience (8+ years) leading strategic HR, organizational transformation, workforce planning, and business change initiatives within large, sophisticated, and matrixed global organizations, preferably as a Global HR Business Partner or in another senior HR leadership role. Lead the end-to-end people and organizational strategy for BioPharma R&D Clinical Operations, shaping workforce transformation, organization capability, succession, talent strategies, and future-ready operating models aligned to evolving business priorities.
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.
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.
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.
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.
Clinical Operations Leader Gates FoundationClinical Operations LeaderCambridge, MassachusettsThe COL will be responsible for ensuring that operational plans are developed to execute clinical studies and deliver quality data through all clinical trial phases across all programs in their assigned portfolio in accordance with the protocol, in compliance with ethical and regulatory requirements and in accordance with company SOPs, GCP and ICH guidelines within timelines and on budget. The successful candidate will be an innovative and collaborative individual who thrives in a “get it done” type of environment with diverse clinical operations experience and the following mix of personal and professional characteristics: 15+ years experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO, with at least 5+ years of people management.
Director, Pharmaceutical Sciences Clinical Manufacturing Business Operations 3316 Takeda Development Center AmericasDirector, Pharmaceutical Sciences Clinical Manufacturing Business OperationsLexington, MassachusettsProvide team leadership to ensure 1) PharmSci business processes are operating smoothly (CapEx, OpEx, Governance), 2) partner with Procurement to deliver year-over-years savings targets, and 3) support PharmSci in the development of SOWs, contracts and any additional purchasing support. 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.