Clinical Trial Manager/ Senior Clinical Trial Manager

Clinical Trial Manager/ Senior Clinical Trial Manager Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment of cancer, autoimmune disorders, and other serious diseases. Leveraging our wholly owned technologies, we have built a robust R&D pipeline, including two clinical-stage candidates currently being evaluated across multiple ongoing clinical studies. Our lead clinical candidate, dibotatug, is designed to induce antibody-mediated killing of a specific cell type implicated in a range of oncology and autoimmune indications. In addition, we have launched multiple programs from our proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody-based technology engineered to selectively engage a novel phagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents. Data generated using the platform support its broad therapeutic potential, including initial programs focused on oncology, immunology, and neurology. Importantly, multispecific antibodies generated from the platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to other immunomodulatory therapies. Clinical Operations Manager/ Senior Manager San Carlos, CA (Remote candidates may be considered) Associate Director, Clinical Study Management We are seeking an exceptionally talented and driven individual for the Clinical Trial Manager/ Senior Clinical Trial Manager position. This role will be responsible for providing operational execution, leadership and support for studies conducted by the Dren Bio team, and work in partnership with internal colleagues, external partners, and investigators and clinical site staff to ensure delivery of high quality clinical studies in a timely manner.

Work with central laboratory vendor on lab specifications, manual, and kit design and database buildWork with central imaging vendor on specifications, charter, manual, supplies, and vendor portal database buildWork with IRT vendor on specifications, build, testing, and manual for drug supply management system Review and contribute to CRF design and database build to ensure integration of all critical aspects of the clinical study being reflected in the clinical database Collaborate with Data Management to oversee data quality issues (query and data quality management and resolution) Lead Clinical Operations team in planning and execution of data cleaning for data deliverables. Cohort screening and enrollment management in coordination with Medical Monitor Collaboration with Medical Monitor and Safety to prepare data and communications for dose escalation Safety Review Committee and DSMB meetings Guide, in conjunction with the CRA lead, the monitoring activity of CRAs and timely execution of data clean efforts to ensure timely data entry and continuous data quality improvements Review and communicate key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team Collaborate with cross-functional teams (e.g., regulatory, translational research, quality, CMC, statistics, etc) in study start-up planning as well as to coordinate efforts for study deliverables (e.g., regulatory submissions, sample reconciliation, PK and exploratory biomarker analyses, SOP development, drug supply projections, pharmacy manual and IP management, developing data cleaning timelines for stats/programming TLF deliverables, etc) Education, Experience and Qualification Requirements: BS/BA in the life sciences or in a related field; an advanced degree (e.g., MS, PharmD, or PhD) is preferred 5-7 years of experience in clinical operations for biotechnology or pharmaceutical employer; experience in autoimmune disease(s) or dermatology highly desirable. Experience with internal model (in-house, non-CRO study management) highly desirable. Experience with clinical systems including various EDC, IRT, TMF, CTMS, etc. Strong organizational, written and verbal communication skills Willingness to travel up to 30% of the time. Permitted to work in the United States. Core Competencies, Knowledge and Skill Requirements: A self-starter who can take on building the operational backbone for early phase clinical studies Experienced in leading international Phase I-III clinical trials Participation in large multi-center and/or global trials, investigational site and CRO management, data collection, and study protocol compliance. Solid understanding of US and global regulations and guidelines (FDA, EMA, ICH) Experience in working in a highly matrix environment and ability to execute in the context of internal and external (vendor) cross-functional teams Desire to learn and grow in terms of scientific knowledge, managerial capabilities and personal development Willingness to take a hands-on approach Ability to work under pressure and aggressive timelines Ability to manage multiple competing priorities, being able to rapidly gather, assimilate and disseminate information on critical project components and milestones Detail oriented with ability to manage technical/scientific aspects as well as operational components of logistics, timing and quality Salaries, Benefits and Other Employee Perks: Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy is embodied in the Company's total rewards program, which includes competitive cash compensation, equity incentive awards, and employer sponsored benefit offerings. The base pay range for this position at commencement of employment is expected to be between $120,000 and $170,000 per year. At Dren Bio, pay ranges are determined by role, level(s), and location. The range displayed in this job posting reflects the minimum and maximum new hire pay for candidates located across all United States job markets. Within the range, individual pay will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, Dren Bio's Human Resources department can share more about the specific pay range based on the market location of the candidate. Employment Practices: Dren Bio is an equal opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Interested Applicants: Please send resume and cover letter to careers@drenbio.com