Director/Senior Director, Clinical Development Operations

Location: San Mateo, CA (Onsite) – four days per week in the office. Up to 20% travel, including international.

About Kivu Bioscience

At Kivu Bioscience, we leverage advanced, next-generation proprietary Antibody Drug Conjugates (ADC) technologies to deliver more precise and effective cancer treatments. Utilizing Synaffix’s site-specific conjugation platform—including the cutting-edge GlycoConnect™ technology—Kivu’s proprietary approach creates highly stable ADCs with optimized linker and payload combinations, designed to maximize therapeutic efficacy while minimizing off-tumor toxicity. By targeting asparagine-297, GlycoConnect™ produces a clean, highly homogenous product, offering a clear manufacturing advantage over other conjugation technologies. With state-of-the-art innovations in conjugation and payload delivery, we are shaping the future of targeted oncology therapies with a commitment to improving patient outcomes and treatment tolerability. Kivu programs employ three technology pillars to deliver best-in-class ADCs by enhancing homogeneity, stability, and potency.

We are driven by our mission to develop groundbreaking therapies that advance oncology treatment and improve patients’ lives. Our success stems from the strength and diversity of our team, and we are deeply committed to creating an environment where every individual can thrive. We foster a collaborative, inclusive culture built on intellectual curiosity, innovation, and a shared passion for making a difference. Our fast-paced environment encourages continuous learning, and we are fully invested in the recruitment, training, and professional growth of each team member.

About the role

The Director / Senior Director ensures that clinical strategies are translated into operational plans and executed in line with clinical development plans (CDPs). 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 strategy and related initiatives. The role aligns operational execution activities with agreed-upon project priorities, timing, budget, and quality requirements, and ensures study conduct adheres to all relevant regulations, including ICH GCP guidelines, local regulatory requirements, and Kivu’s policies and SOPs.

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 enrollment and other activities.
• Plan and conduct 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 ensure the TMF and study is always “inspection ready.”
• Prepare high-quality reports (financial, project, etc.) for executive management on program status and issues as required.
• Provide management, oversight, coaching, mentoring, and development to a team of indirect reports supporting the clinical trials team and cross-functional teams.

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 collaborate 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.

Benefits

• Full health benefits (medical, dental, vision).
• 401K contribution.