RONDO THERAPEUTICS DIRECTOR of CLINICAL OPERATIONS
(FULL-TIME, SALARY POSITION)
Rondo Therapeutics is a privately held 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 Director of Clinical Operations will provide strategic leadership in support of our clinical development vision and manage and execute one or more oncology first in human phase I-II global clinical trials. The ideal candidate must be able to manage all clinical operational aspects of one or more clinical trials. Experience in Early Phase clinical trial management is preferred, including study start-up activities, patient enrollment initiatives, study maintenance, and close-out. The applicant must be detail-oriented and able to contribute to writing study protocols, informed consent forms, study manuals, develop SOPs, etc.
We are seeking an experienced leader capable of providing strategic insights and technical expertise while navigating a complex global clinical trial landscape. The candidate must maintain a balance between ensuring the highest quality standards and driving the vision for our platform under aggressive timelines.
Key Responsibilities
· Provide leadership and oversight in all aspects of clinical operations, from planning and executing programs to project oversight.
· Provide strategic operational input to Clinical Development Plan (CDP) and project plans.
· Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics, timelines, and critical study activities.
· Develop and maintain enrollment and budget forecasts.
· Manage CROs and third-party vendors to ensure delivery against the contracted scope of work and budget.
· Assist in executing and managing legal contracts from clinical sites, vendors, etc., in conjunction with outside legal counsel.
· Participate in selecting CRO and vendors, including developing RFPs, budget negotiations, and management.
· Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA, and contribute to IND filings.
· Responsible for oversight and project management of individual studies and relevant program-related activities with minimal supervision, including managing team meetings (Agendas, Minutes, Action Items, Follow-up).
· Develop and review SOP processes and guidelines for compliance with global regulatory requirements.
· Ensure development study plans and provide adequate oversight for vendor oversight, risk, safety, and communication.
· Provide supervision, coaching, and mentoring and contribute to hiring new staff.
· Proactively identify risks and develop and implement mitigation strategies.
· Self-motivated and able to thrive in a fast-paced, start-up environment.
· Plan, participate, and facilitate operational-level governance with vendors as appropriate.
· Ensure timely and effective risk mitigation and escalation for projects and programs.
· Provide senior executive management with project and program updates.
· Partner with cross-functional peers & staff to build execution plans & meet critical business milestones.
· Be able to travel (<20%).
Preferred Qualifications
· Level commensurate with experience.
· Bachelor’s degree or equivalent is required.
· Must have at least 10 years of relevant trial leadership experience in either sponsor or CRO.
· Phase I-II Global Trial Management experience.
· Strong track record for successful study initiation and execution.
· Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE, and other relevant guidelines and regulations.
· Experience managing CROs and third-party vendors.
· Experience in Finance Management, including but not limited to Budget Forecasting, Change Order Management.
· Experience working with EDC, CTMS, and eTMF systems.
· Strong interpersonal communication skills.
· Able to prioritize critical business needs.
· Able to engage in strategic business discussions and craft executive-level communications and materials.
· Excellent cross-functional clinical project management skills.
· Must have exceptional leadership skills, including motivation and delegation.
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 a fearless clinical operations leader driven to make new discoveries, and you value collaboration, respect, and working in a team environment, then we want to hear from you! Join us in our mission to create 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 Operations 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 salary range for the position is $160K to $250K per 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.
