Associate Director / Director Clinical Operations

Location: San Mateo, CA (Onsite)
Job Type: Full time employee
Report to: Executive Vice President, Clinical Development Operations

Job Summary:

The Clinical Operations Study Lead ensures that clinical strategies are translated into operational plans and executed in strategy and related initiatives including aligning operational execution activities with agreed upon project priorities, timing, budget, and quality requirements. This position ensures study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Kivu’s policies and SOPs.
This role is expected to require up to 20% travel, including international travel. This role is based in San Francisco Bay Area, San Mateo County CA.
This position is responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations in line with Kivu’s clinical development plans (CDPs).

Roles & Responsibilities:

Manage all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance with applicable SOPs, guidelines, and regulations.
Develop study level operational strategy and clinical operations plans in support of execution of the Program-level objectives/CDP.
Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities.
Support the selection, oversight, and management of CROs and other vendors.
Monitor and assess vendor performance against contractual operational deliverables.
Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors.
Provide oversight of study scope, quality, timelines, and budget with the internal Kivu functional leads, CRO and vendors to ensure project objectives remain on track.
Lead cross-functional teams and manage the study team in partnership with the CRO.
Participate in a site engagement program to build solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities.
Responsible for planning and conducting investigator meetings together with the CRO.
Partner with the CRO to ensure patient enrollment strategies are conducted effectively and on time.
Coordinate and participate in proactive data monitoring activities to ensure quality and completeness of study data.
Evaluate issues, interpret data, and suggest and implement solutions and mitigation as required.
Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances.
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate.
Provide ongoing oversight, maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures the TMF and study is always “inspection ready.”
Prepare high-quality reports (financial, project, etc.) for senior management on program status and issues as required.
Provide management, oversight, coaching, mentoring, and development to team of indirect reports supporting the clinical trials team and cross-functional teams.

Qualification & Education Requirements:

Undergraduate degree in a scientific or health related discipline. Advanced scientific or business degree or equivalent experience desirable.
Minimum of 8 to 10 years of clinical trial management experience in conducting Phase 1-3 global clinical trials, preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline, and budget expectations. Prior site and/or monitoring experience are advantageous.
Experience in oncology, antibody drug conjugates experience preferred.
Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws.
Understand clinical study budgets, accruals, and forecasting.
Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously.
Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships.
Experience in vendor selection and overseeing studies being managed by a CRO.
Ability to successfully engage and work collaboratively with cross functional team members including, but not limited to, regulatory, CMC, project management, safety, and medical monitors.
Demonstrated ability to solve problems and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
Independently motivated, detail oriented and good problem-solving ability.
Excellent communication skills.

About Kivu Bioscience:

Kivu Bioscience is pioneering next-generation antibody-drug conjugates (ADCs) in oncology. The company’s proprietary linker-payload technology delivers enhanced safety and efficacy, minimizing off-target effects to improve patient outcomes. With multiple ADC programs in development and a team of industry veterans, Kivu is advancing its first two lead candidates to clinical trials. The company is headquartered in San Mateo, CA.

To learn more, visit https://kivubioscience.com/

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