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 aspargine-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.
At Kivu Bioscience, 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.
Overview
The Executive Director/Vice President, Clinical Development, provides medical leadership for the design, execution, and interpretation of clinical development programs across early and late-stage oncology assets. This individual serves as the clinical lead for KIVU development programs and collaborates with cross-functional teams to advance innovative therapies from first-in-human studies through clinical proof of concept and regulatory approval. The Executive Director/Vice President is responsible for developing clinical strategies, overseeing study conduct, interpreting clinical data, and engaging with investigators, regulatory agencies, and key opinion leaders to ensure successful execution of the clinical development plan.
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 with four days required in the office.
Primary Responsibilities
Clinical Development Leadership
- Lead the clinical development strategy for Kivu Bioscience products in conjunction with the Chief Medical Officer.
- Develop Clinical Development Plans (CDPs), Target Product Profiles (TPPs), and clinical protocols aligned with regulatory and commercial objectives.
- Provide medical oversight for ongoing clinical trials, ensuring patient safety, scientific integrity, and operational excellence.
- Review and interpret clinical efficacy, safety, pharmacokinetic, and biomarker data to support program decision-making.
- Serve as the medical monitor for clinical studies, including safety review and protocol deviation assessment
- Hire and supervise employees, both directly and indirectly.
- Oversee performance management and career development for direct reports.
Study Design & Execution
- Author and review clinical protocols, investigator brochures, informed consent documents, clinical study reports, regulatory documents.
- Partner with Clinical Development Operations to support site selection, enrollment strategies, and study execution.
- Collaborate with Biostatistics and Data Management on statistical analysis plans and data interpretation.
- Participate in Safety Review Committees, and Study Governance meetings.
- Work with multidisciplinary teams to ensure quality oversight of the study (quality, regulatory, and safety)
- Ensure that all company clinical trials are conducted according to GCP and all applicable regulatory requirements, with a focus on the safety and medical monitoring aspects of the trial(s).
Regulatory & Health Authority Interactions
- Lead the development of clinical sections for regulatory submissions, including INDs, CTAs, and when appropriate, NDAs, BLAs, and marketing applications.
- Participate in interactions with FDA, EMA, and other global health authorities.
- Support responses to regulatory questions and inspection readiness activities.
Scientific & External Engagement
- Represent the company at scientific congresses, investigator meetings, and advisory boards.
- Support publication strategy and dissemination of clinical data through abstracts, presentations, and peer-reviewed publications.
Cross-Functional Collaboration
- Work closely with Translational Medicine, Clinical Pharmacology, Biometrics, Regulatory Affairs, CMC, Business Development and Pharmacovigilance teams.
- Provide clinical expertise for portfolio strategy, business development evaluations, and due diligence activities.
- Support lifecycle management and indication expansion strategies.
Education and Skill Requirements/Qualifications
- MD or DO required.
- Board certification or board eligibility in Medical Oncology, Hematology/Oncology, or a related specialty preferred with experience/knowledge/familiarity with antibody-drug conjugates (ADCs)
- Minimum 10 years clinical research experience in Oncology Clinical Development within a biotechnology and/or pharmaceutical company.
- Demonstrated leadership overseeing oncology clinical development programs with multiple assets from early through late-stage development.
- Strong understanding of oncology drug development, GCP, ICH guidelines, and global regulatory requirements.
- Experience serving as a medical monitor for early-phase clinical development and dose-escalation studies is highly desirable.
- Expertise in oncology clinical trial design and execution.
- Strong understanding of precision medicine, biomarkers, companion diagnostics, and translational research.
- Excellent written and verbal communication skills.
- Collaborative leadership style with a commitment to innovation and patient-centric development.
Renumeration: Annual salary commensurate of experience and education training, full health benefits (medical, dental, vision), 401K contribution.
Kivu Bioscience, Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of an inclusive workforce. It is the Company’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Kivu Bioscience, Inc. maintains a drug-free workplace.