[Remote] Associate Director, Clinical Operations

Note: The job is a remote job and is open to candidates in USA. BBOT is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for cancer treatment. The Associate Director of Clinical Operations will lead clinical trial activities, manage study teams, and ensure compliance with regulatory standards while maintaining relationships with investigators and vendors.ResponsibilitiesStudy Planning and ManagementAccountable for overall management of clinical trials, including providing strategic direction to the study team, to meet corporate goals and timelinesCollaborate with the Clin Development to assess study progress, ensure proper study conduct and adherence to the protocolCentral role maintaining relationships with other internal functions, strategic partners and CROsOversee functional deliverables to support program objectives, identify risks to study timelines, propose mitigations, and implement solutions with team and management supportCommunicate program status, cost, and issues to senior managementDaily activities may include updating / reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, study plans, etc.), monitoring study status, evaluating and keeping in place a suitable resource plan, anticipating and mitigating risks within the timeline, quality and cost paradigmMonitor global regulatory intelligence for international industry practices for operational efficiency and complianceResponsible for the coordination of team meetings, as assigned, with both internal and external partnersServe as a clinical trial lead for one or more trials and responsible for implementation, planning, and execution of clinical trial activitiesCultivate and maintain strong relationships with investigators, and trial site managers and other site staff, as applicableParticipates in the selection of vendors and manages their activitiesOrganize investigator meetings, as neededCoordinate timely data review to identify trends and discrepanciesResponsible for all aspects of site management from feasibility, selection, start-up, maintenance, and close outSelect, assess, and approve sites for activationContribute to study budget, including regular forecasting and internal reportingReview invoices against scope of work and work completed to date, and to identify and communicate variancesProvides critical deliverable, milestone feedback and other as needed input in contract negotiationsResponsible for management of CRO and vendors to support clinical operations contracted for the assigned study/studiesOversee vendor performance by developing positive partner relationship, responsible for identifying risks issue resolution and first line of study team governanceResponsible for deliverables are per budgets and agreed upon timelinesResponsible for reviewing and approving invoices from study vendorsWorks intimately with internal and external Teams (DM, Bio Stat, contribution functional areas) on the overall development and maintenance of a study EDC to ensure that all necessary data is captured to achieve study objectivesLead activities related to clinical data review/query resolution; ensure consistent quality data reviewContribute to the testing of EDCContribute to development, training, implementation, and monitors compliance of Standard Operating ProceduresProvide active support with the development, implementation and continued maintenance of quality control processes and workflows to ensure that all clinical trial activities are compliant with Good Clinical Practices and applicable regional regulatory guidelinesActs as liaison for Clin Ops between the sites and study team for audits on an ongoing basisLead Clin Ops aspects of inspection readiness activities and act as an expert during regulatory inspectionsResponsible for ensuring the coordination and planning, working with Clinical Supplies, for availability of clinical and non-clinical supplies at sites (drug supplies, and other required materials critical for study conduct)Manage, direct, and mentor junior members of the Clinical Operations team, as applicableOther duties as assignedSkillsBA/BS required in a scientific / medical field, or equivalent work experience8- 10 years of industry experienceDemonstrated ability to successfully manage and support clinical trial deliverables from start-up through close-out, including all financial tracking and reporting activitiesUnderstanding of clinical trial design, protocol development and reviewExtensive experience with cross-functional leadership and clinical teams, including data review, database lock and study reporting activitiesVendor management experience required given many accomplishments will come from external resourcesExperience in maintenance of a submission ready eTMF requiredExperience in Quality Assurance, SOP (Standard Operating Procedure), and study plan writing, CAPA (corrective and preventative action) preparation and closureExperience with investigator-initiated and industry-sponsored studiesStrong knowledge of GCP (Good Clinical Practice) and working knowledge in ICH (International Conference on Harmonization) GCP (Good Clinical Practice) E6 R2 regulationsKnowledge of GDPR (General Data Protection Regulation) and how to apply appropriate practices to clinical trialsLeadership ability and further potential to build relationships in a matrix environment, ability to multi-task in a dynamic and fast paced environmentExcellent interpersonal, written, and verbal skills requiredWorking experience / knowledge of timeline management tools (e.g., Smartsheet)Position title based on experience, capabilities and demonstrated competenciesExperience in oncology studies is preferredBenefitsAnnual bonusStock-based long-term incentivesMedical, dental, and vision benefitsRetirementWellness stipendFlexible time offCompany OverviewBBOT (BridgeBio Oncology Therapeutics) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. It was founded in undefined, and is headquartered in South San Francisco, California, US, with a workforce of 51-200 employees. Its website is https://www.bbotx.com.