Clinical Trial Manager/ Senior Clinical Trial Manager

About The Company

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. For more information, please visit our website at www.drenbio.com.

Function

Clinical Operations

Level

Manager/ Senior Manager

Location:

San Carlos, CA (Remote candidates may be considered)

Reporting Manager

Associate Director, Clinical Study Management

About The Opportunity

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.

Role And Responsibilities

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 studymanagement)

Contribute to the identification and selection of appropriate ex-US CROs andthird-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 vendorson study protocol, associated documents, and key decisions and communications

Ensure study team members and vendors are trained on protocol, relevant studydocuments, and key decisions at study start-up and throughout the duration of thestudyManage the development of clinical protocols, amendments, informed consent forms,study plans and any other clinical research related documents, in collaboration withcross-functional team members or CRO-partnersOrganize and run study team meetings on a regular basis to ensure clear and currentcommunication, escalation of potential issues to the appropriate functional leadsand team-based problem solving and risk mitigation of any arising roadblocksEstablish and maintain excellent working relationships with investigators and studystaffEnsure studies are carried out according to the study protocol, SOPs, and ICH/GCPguidelines and study specific manuals and proceduresParticipate in feasibility process for finding and selecting new study sitesOversee CTA management of site start-up activityWork with central laboratory vendor on lab specifications, manual, and kit design anddatabase buildWork with central imaging vendor on specifications, charter, manual, supplies, andvendor portal database buildWork with IRT vendor on specifications, build, testing, and manual for drug supplymanagement systemReview and contribute to CRF design and database build to ensure integration of allcritical aspects of the clinical study being reflected in the clinical databaseCollaborate with Data Management to oversee data quality issues (query and dataquality management and resolution)Lead Clinical Operations team in planning and execution of data cleaning for datadeliverables.Cohort screening and enrollment management in coordination with Medical MonitorCollaboration with Medical Monitor and Safety to prepare data and communications fordose escalation Safety Review Committee and DSMB meetingsGuide, in conjunction with the CRA lead, the monitoring activity of CRAs and timelyexecution of data clean efforts to ensure timely data entry and continuous dataquality improvementsReview and communicate key study quality metrics (e.g., eligibility, primary endpointdata, etc.) and determine appropriate action in conjunction with study teamCollaborate with cross-functional teams (e.g., regulatory, translational research,quality, CMC, statistics, etc) in study start-up planning as well as to coordinateefforts 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 forstats/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 pharmaceuticalemployer; experience in autoimmune disease(s) or dermatology highly desirable.Experience with internal model (in-house, non-CRO study management) highlydesirable.

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 phaseclinical studies

Experienced in leading international Phase I-III clinical trials

Participation in large multi-center and/or global trials, investigational site andCRO 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 thecontext of internal and external (vendor) cross-functional teams

Desire to learn and grow in terms of scientific knowledge, managerial capabilitiesand 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 asoperational 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.