Dren Bio (the "Company") is a privately held, clinical stage biopharmaceutical company focused on developing therapeutic antibodies for the treatment of cancer, autoimmune and other serious diseases. The Company's management team and scientific advisors have profound expertise covering the discovery and development of engineered antibodies designed to selectively target and deplete pathological cells. Dren Bio's pipeline is currently comprised of two distinct drug discovery programs. The Company's first program surrounds DR-01, its lead product candidate, which induces antibody-mediated killing of a cell type that is responsible for a multitude of hematologic malignancies and plays a key role in various autoimmune diseases. The Company's second program surrounds its Targeted Myeloid Engager and Phagocytosis Platform, a proprietary bispecific antibody-based technology that provides a novel mechanism of action to selectively engage myeloid cells for (1) targeted depletion of pathologic cells and other disease-inducing agents and (2) inducing localized immunostimulation. The engagement of antigen presenting cells has the potential to elicit a sustained, durable response.
Clinical
Manager/ Senior Manager
Foster City, CA (Remote candidates may be considered)
Director of Clinical Operations
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.
Responsible for clinical study execution and oversight of all operational aspects
Lead in-house study management in the United States (no CRO contracted for US study management)
Contribute to the identification and selection of appropriate ex-US CROs and third-party study vendors
Oversee performance of ex-US CROs and vendors to ensure study execution
Develop study training slides and materials and train study team members and vendors on study protocol, associated documents, and key decisions and communications
Ensure study team members and vendors are trained on protocol, relevant study documents, and key decisions at study start-up and throughout the duration of the study
Manage the development of clinical protocols, amendments, informed consent forms, study plans and any other clinical research related documents, in collaboration with cross-functional team members or CRO-partners
Organize and run study team meetings on a regular basis to ensure clear and current communication, escalation of potential issues to the appropriate functional leads and team-based problem solving and risk mitigation of any arising roadblocks
Establish and maintain excellent working relationships with investigators and study staff
Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines and study specific manuals and procedures
Participate in feasibility process for finding and selecting new study sites
Oversee CTA management of site start-up activity
Work with central laboratory vendor on lab specifications, manual, and kit design and database build
Work with central imaging vendor on specifications, charter, manual, supplies, and vendor portal database build
Work 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)
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) 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
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
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 $135,000 and $175,000 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..
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.
Please send resume and cover letter to careers@drenbio.com
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