Rondo Therapeutics
Clinical Trial Manager (CTM)/Sr. CTM
Rondo Therapeutics, Emeryville, California, United States, 94608
RONDO THERAPEUTICS CLINICAL TRIAL MANAGER (CTM)/Sr. CTM
Rondo Therapeutics is a privately held clinical‑stage biotechnology company committed to advancing the field of immuno‑oncology with a focus on treating solid tumors that fail to respond to current therapies. Our solution is to create a new class of bispecific antibodies that safely engage the immune system to initiate and sustain a robust anti‑tumor response.
Rondo was launched in 2021 by experienced entrepreneurs in the field of immuno‑oncology. Rondo has raised Series A financing led by a world‑class syndicate of investors to support the growth of our Hayward, California‑based research site.
www.rondotx.com
POSITION SUMMARY
The Clinical Trial Manager (CTM)/Sr. CTM will provide operational and technical expertise to help plan and execute one or more of Rondo’s oncology first‑in‑human phase 1 global clinical trials. This role will be responsible for overseeing all aspects of daily operations of the clinical trial, including management and oversight of the clinical research organization (CRO). The ideal candidate will have extensive, hands‑on experience working in a dynamic fast‑paced environment.
As Rondo advances its first oncology asset into Phase 1 clinical trials, we are seeking a talented, experienced, and highly motivated CTM/Sr.CTM to join our oncology Clinical Operations team. The candidate must have the ability to work independently, be an effective leader, and act as an engaged clinical study team member. You will play a key role in contributing to high‑quality in‑house clinical study management, ensuring compliance with regulatory guidelines, and contributing to planning, managing and successful completion of global clinical trials.
This is a hybrid position reporting directly to the Vice President of Clinical Operations; the CTM/Sr.CTM will partner with the cross‑functional team to contribute to the execution of the clinical strategy of the company. The ideal candidate will bring strong experience in early‑phase oncology clinical trials, a collaborative management style, and a passion for advancing innovative therapies.
Key Responsibilities
Manage global phase 1/1b clinical trial(s) to ensure that all key trial milestones and activities are completed on‑time and within budget, by managing key components of the trial.
Contribute to the development and maintenance of key trial documents such as protocols, ICFs, study plans, etc.
Drive the timing of critical site and trial management activities such as development of clinical trial agreements and budgets, site activations, subject enrollment, monitoring visit schedules, data entry into the electronic data capture (EDC) system, query resolution and review monitoring visit reports.
Generate and maintain internal trial management trackers and reports.
Monitor and manage clinical supply activities through the Interactive Response Technology (IRT) to predict the amount and timing of Investigational Product (IP) shipments to clinical sites.
Collaborate with the Chemistry, Manufacturing and Controls (CMC) department on drug forecasting and timing of resupply(ies).
Coordinate biosample logistics with central and third‑party labs to ensure sample delivery, resolution of queries, data transfers and support data analysis and interpretation.
Participate in regularly scheduled CRO meetings to support management of study start‑up, maintenance, and close‑out activities.
Manage CRO and third‑party vendors supporting clinical trials to ensure delivery against contracted scope of work and budget.
Track timely scheduling of monitoring visits; track and review timely completion and monitoring visit reports.
Oversee eTMF activities at CRO, including final reconciliation of eTMF prior to transfer to Rondo at study close‑out.
Clinical Trial Quality & Compliance
Partner with CRO project lead to ensure Rondo sponsored clinical trials are conducted in accordance with ICH GCPs; contribute to any inspection readiness activities as appropriate for each phase of clinical development.
Partner with internal and external data management lead to ensure high quality and timely data.
Track and identify any trends or signals while performing routine review of study data listings, trackers, or monitoring visit reports.
Department Support
Provide strategic operational input to Clinical Development Plan (CDP) and project plans.
Support department process improvement initiatives and SOP development as needed.
Support maintenance of internal organization and storage of study documents and files.
Preferred Qualifications
B.S. in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent) preferred.
5+ years of experience in the biotechnology or pharmaceutical industry, with a minimum of 3 years clinical trial management experience in oncology.
Strong knowledge of ICH, GCP, FDA, EMEA, and other relevant guidelines and regulations.
Experience in oncology solid tumor drug development experience, with strong grasp of fundamentals of clinical trial design and execution as well as the overall clinical development process.
Proven track record of working on phase 1 global clinical trials.
Experience with managing CROs and clinical trial vendors, including tracking vendor performance management and managing vendor budgets and invoices.
Requires project management skills, strong organization, and time management skills along with study leadership abilities.
Self‑motivated, with initiative and the ability to take ownership of, and follow through with specific tasks or assigned projects.
Work with limited supervision both independently and as part of a team with the ability to handle competing priorities.
Flexible and willing to roll up your sleeves and be hands on in a dynamic start‑up environment, taking on a wide range of clinical operations tasks as needed.
Strong communication skills, with the ability to influence key stakeholders.
Willingness to travel as necessary, consistent with project needs (domestic and international), up to 15 %.
CONSIDER JOINING OUR TEAM
At Rondo Therapeutics we believe that our success as a company starts with building a culture based on teamwork, mutual trust, a focus on career growth, and a sense of fun.
If you are fearless and driven and value collaboration, respect, and working in a team environment, then we want to hear from you! Join us in our mission to advance novel molecules that bring new hope to cancer patients while advancing your career in a merit‑based culture.
Our benefits include :
Competitive compensation packages, with equity and discretionary annual bonuses
Comprehensive healthcare plans covering employees 100% for medical, dental, vision, life and disability insurance
Access to an employer matched 401(k) savings plan
PTO, national holidays and a holiday shutdown
Access to healthcare and dependent care FSA accounts
Please email your resume and cover letter to jobs@rondotx.com with the Subject Line: “ Clinical Trial Management Position ”. In your cover letter, please outline how your experience aligns with the key responsibilities of this role.
This is a full‑time position based in Hayward, CA.
Compensation and title are dependent on relevant experience. The expected pay range for this position is $135,000 - $180,000/year.
Rondo Therapeutics is proud to be an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, color, national origin, ancestry, creed (religion), gender or gender identity, sexual orientation, military status, citizenship status, age, disability, genetic characteristics, marital status, or any other characteristic protected by applicable law.
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Rondo Therapeutics is a privately held clinical‑stage biotechnology company committed to advancing the field of immuno‑oncology with a focus on treating solid tumors that fail to respond to current therapies. Our solution is to create a new class of bispecific antibodies that safely engage the immune system to initiate and sustain a robust anti‑tumor response.
Rondo was launched in 2021 by experienced entrepreneurs in the field of immuno‑oncology. Rondo has raised Series A financing led by a world‑class syndicate of investors to support the growth of our Hayward, California‑based research site.
www.rondotx.com
POSITION SUMMARY
The Clinical Trial Manager (CTM)/Sr. CTM will provide operational and technical expertise to help plan and execute one or more of Rondo’s oncology first‑in‑human phase 1 global clinical trials. This role will be responsible for overseeing all aspects of daily operations of the clinical trial, including management and oversight of the clinical research organization (CRO). The ideal candidate will have extensive, hands‑on experience working in a dynamic fast‑paced environment.
As Rondo advances its first oncology asset into Phase 1 clinical trials, we are seeking a talented, experienced, and highly motivated CTM/Sr.CTM to join our oncology Clinical Operations team. The candidate must have the ability to work independently, be an effective leader, and act as an engaged clinical study team member. You will play a key role in contributing to high‑quality in‑house clinical study management, ensuring compliance with regulatory guidelines, and contributing to planning, managing and successful completion of global clinical trials.
This is a hybrid position reporting directly to the Vice President of Clinical Operations; the CTM/Sr.CTM will partner with the cross‑functional team to contribute to the execution of the clinical strategy of the company. The ideal candidate will bring strong experience in early‑phase oncology clinical trials, a collaborative management style, and a passion for advancing innovative therapies.
Key Responsibilities
Manage global phase 1/1b clinical trial(s) to ensure that all key trial milestones and activities are completed on‑time and within budget, by managing key components of the trial.
Contribute to the development and maintenance of key trial documents such as protocols, ICFs, study plans, etc.
Drive the timing of critical site and trial management activities such as development of clinical trial agreements and budgets, site activations, subject enrollment, monitoring visit schedules, data entry into the electronic data capture (EDC) system, query resolution and review monitoring visit reports.
Generate and maintain internal trial management trackers and reports.
Monitor and manage clinical supply activities through the Interactive Response Technology (IRT) to predict the amount and timing of Investigational Product (IP) shipments to clinical sites.
Collaborate with the Chemistry, Manufacturing and Controls (CMC) department on drug forecasting and timing of resupply(ies).
Coordinate biosample logistics with central and third‑party labs to ensure sample delivery, resolution of queries, data transfers and support data analysis and interpretation.
Participate in regularly scheduled CRO meetings to support management of study start‑up, maintenance, and close‑out activities.
Manage CRO and third‑party vendors supporting clinical trials to ensure delivery against contracted scope of work and budget.
Track timely scheduling of monitoring visits; track and review timely completion and monitoring visit reports.
Oversee eTMF activities at CRO, including final reconciliation of eTMF prior to transfer to Rondo at study close‑out.
Clinical Trial Quality & Compliance
Partner with CRO project lead to ensure Rondo sponsored clinical trials are conducted in accordance with ICH GCPs; contribute to any inspection readiness activities as appropriate for each phase of clinical development.
Partner with internal and external data management lead to ensure high quality and timely data.
Track and identify any trends or signals while performing routine review of study data listings, trackers, or monitoring visit reports.
Department Support
Provide strategic operational input to Clinical Development Plan (CDP) and project plans.
Support department process improvement initiatives and SOP development as needed.
Support maintenance of internal organization and storage of study documents and files.
Preferred Qualifications
B.S. in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent) preferred.
5+ years of experience in the biotechnology or pharmaceutical industry, with a minimum of 3 years clinical trial management experience in oncology.
Strong knowledge of ICH, GCP, FDA, EMEA, and other relevant guidelines and regulations.
Experience in oncology solid tumor drug development experience, with strong grasp of fundamentals of clinical trial design and execution as well as the overall clinical development process.
Proven track record of working on phase 1 global clinical trials.
Experience with managing CROs and clinical trial vendors, including tracking vendor performance management and managing vendor budgets and invoices.
Requires project management skills, strong organization, and time management skills along with study leadership abilities.
Self‑motivated, with initiative and the ability to take ownership of, and follow through with specific tasks or assigned projects.
Work with limited supervision both independently and as part of a team with the ability to handle competing priorities.
Flexible and willing to roll up your sleeves and be hands on in a dynamic start‑up environment, taking on a wide range of clinical operations tasks as needed.
Strong communication skills, with the ability to influence key stakeholders.
Willingness to travel as necessary, consistent with project needs (domestic and international), up to 15 %.
CONSIDER JOINING OUR TEAM
At Rondo Therapeutics we believe that our success as a company starts with building a culture based on teamwork, mutual trust, a focus on career growth, and a sense of fun.
If you are fearless and driven and value collaboration, respect, and working in a team environment, then we want to hear from you! Join us in our mission to advance novel molecules that bring new hope to cancer patients while advancing your career in a merit‑based culture.
Our benefits include :
Competitive compensation packages, with equity and discretionary annual bonuses
Comprehensive healthcare plans covering employees 100% for medical, dental, vision, life and disability insurance
Access to an employer matched 401(k) savings plan
PTO, national holidays and a holiday shutdown
Access to healthcare and dependent care FSA accounts
Please email your resume and cover letter to jobs@rondotx.com with the Subject Line: “ Clinical Trial Management Position ”. In your cover letter, please outline how your experience aligns with the key responsibilities of this role.
This is a full‑time position based in Hayward, CA.
Compensation and title are dependent on relevant experience. The expected pay range for this position is $135,000 - $180,000/year.
Rondo Therapeutics is proud to be an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, color, national origin, ancestry, creed (religion), gender or gender identity, sexual orientation, military status, citizenship status, age, disability, genetic characteristics, marital status, or any other characteristic protected by applicable law.
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