Clinical Trial Manager/ Senior Clinical Trial Manager

Dren Bio, Inc.; San Carlos (CA); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Dren Bio, Inc. in San Carlos, CA is seeking a Clinical Trial Manager/Senior Clinical Trial Manager to lead in-house US study management and coordinate CROs and vendors. You will ensure timely, high-quality study execution in a fast-paced, innovative setting.

The role requires 5–7 years in clinical operations, strong experience with EDC/IRT/CTMS, and excellent organizational and communication skills. Travel up to 30% and US work authorization are expected.

Qualifications

• 5–7 years of experience in clinical operations for biotechnology or pharmaceutical employer; autoimmune/dermatology experience desirable.
• Experience with internal model (in-house, non-CRO study management) desirable.
• Experience with clinical systems including EDC, IRT, TMF, CTMS, etc.

Responsibilities

• Lead in-house study management for US studies (no CRO contracted for US study management).
• Identify and select ex-US CROs and third-party study vendors; oversee performance.
• Develop study protocols, amendments, informed consent forms, study plans and related documents with cross-functional teams.

Skills

In-house study management

CRO management

Clinical operations

US regulatory

Education

BS/BA in life sciences

Advanced degree preferred

Tools

EDC

IRT

TMF

CTMS

Job description

Clinical Trial Manager/ Senior Clinical Trial Manager

About the Company:

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering thediscovery and development of first-in-class antibody therapeutics for the treatment ofcancer, autoimmune disorders, and other serious diseases. Leveraging our wholly ownedtechnologies, we have built a robust R&D pipeline, including two clinical-stage candidatescurrently being evaluated across multiple ongoing clinical studies. Our lead clinicalcandidate, dibotatug, is designed to induce antibody-mediated killing of a specific celltype implicated in a range of oncology and autoimmune indications. In addition, we havelaunched multiple programs from our proprietary Targeted Myeloid Engager and PhagocytosisPlatform, a multispecific antibody-based technology engineered to selectively engage a novelphagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeteddepletion of pathologic cells and other disease-causing agents. Data generated using theplatform support its broad therapeutic potential, including initial programs focused ononcology, immunology, and neurology. Importantly, multispecific antibodies generated fromthe platform are specially designed to activate phagocytic mechanisms only in the presenceof disease targets, potentially offering a superior safety profile compared to otherimmunomodulatory therapies. For more information, please visit our website atwww.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 TrialManager/ Senior Clinical Trial Manager position. This role will be responsible for providingoperational execution, leadership and support for studies conducted by the Dren Bio team,and work in partnership with internal colleagues, external partners, and investigators andclinical 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 thestudy

Manage 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-partners

Organize 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 roadblocks

Establish and maintain excellent working relationships with investigators and studystaff

Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCPguidelines 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 anddatabase build

Work with central imaging vendor on specifications, charter, manual, supplies, andvendor portal database build

Work with IRT vendor on specifications, build, testing, and manual for drug supplymanagement system

Review and contribute to CRF design and database build to ensure integration of allcritical aspects of the clinical study being reflected in the clinical database

Collaborate 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 Monitor

Collaboration with Medical Monitor and Safety to prepare data and communications fordose escalation Safety Review Committee and DSMB meetings

Guide, 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 improvements

Review and communicate key study quality metrics (e.g., eligibility, primary endpointdata, 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 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 QualificationRequirements:

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 SkillRequirements:

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 isembodied in the Company’s total rewards program, which includes competitive cashcompensation, equity incentive awards, and employer sponsored benefit offerings. The basepay range for this position at commencement of employment is expected to be between $120,000and $170,000 per year. At Dren Bio, pay ranges are determined by role, level(s), andlocation. The range displayed in this job posting reflects the minimum and maximum new hirepay for candidates located across all United States job markets. Within the range,individual pay will be determined by work location and additional factors, includingjob-related skills, experience, and relevant education or training. During the hiringprocess, Dren Bio’s Human Resources department can share more about the specific pay rangebased on the market location of the candidate.

Employment Practices:

Dren Bio is an equal opportunity employer. Employment decisions are based on merit andbusiness needs. Dren Bio will not discriminate against any job applicant because of race,color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physicalor mental disability, gender identity, medical condition, pregnancy, marital status, veteranstatus, or any other characteristic protected by federal, state or local law.