Senior Medical Director/Medical Director Clinical Development

About the Company

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.

About the Role

The Senior Medical Director/Medical Director Clinical Development leads the development, evaluation, planning, and execution of clinical studies and ensures scientific integrity and interpretation of study data for a clinical development program. This role operates in a matrix environment as part of a cross-functional team and contributes to candidate development projects through early and/or late-phase development. The position reports to the Chief Medical Officer.

This role is based in the San Francisco Bay Area (San Mateo County, CA) with four days required in the office per week and may require up to 20% travel, including international travel.

Responsibilities

• Contribute to and execute clinical trial strategies for Kivu Bioscience products in clinical development.
• Design, author, analyze, report, and publish Kivu Bioscience-sponsored clinical trials.
• Work closely with Clinical Development Operations and other cross-functional teams to support the execution of each assigned study.
• Collaborate with multidisciplinary teams to support data cleaning and database lock activities.
• Ensure quality oversight of studies (quality, regulatory, and safety) through cross-functional collaboration.
• Contribute to the development of clinical sections for regulatory submissions.
• Ensure all company clinical trials are conducted according to GCP and applicable regulatory requirements, with a focus on safety and medical monitoring.
• Develop working relationships with key investigators in oncology to maximize scientific quality in study design, execution, reporting, and publication.
• Contribute to clinical sections of regulatory documents (e.g., Investigators’ Brochures, safety updates, IND/BLA submissions, responses to Health Authorities).
• Participate in trial-related advisory boards and investigator meetings.
• Work with CRO data management and clinical sub-teams to ensure data integrity and quality analysis of studies and filing activities.
• Serve as the external clinical “face” of the program in interactions with investigators, development partners, and advisory boards.
• Collaborate with other functions to support regulatory submissions (e.g., Breakthrough/Fast Track Designation, pre-IND, and IND submissions).
• Promote consistent first-line medical/clinical data review techniques and conventions across studies/programs; review clinical data review plans and author medical monitoring plans for assigned studies/programs.

Requirements

• MD, PharmD, PhD, or equivalent is preferred.
• Minimum of 6 years of oncology clinical drug development experience.
• Experience with ICH guidelines, GCP, and each step within the clinical trial process.
• Familiarity with US/EU patient data privacy laws.
• Experience in oncology; antibody drug conjugates (ADC) experience preferred.
• Demonstrated ability to lead teams in a fast-paced, matrixed environment and manage multiple tasks simultaneously.
• Ability to work collaboratively with cross-functional team members.
• Strong problem-solving skills and clear judgment in relation to regulatory requirements, external interactions, timelines, and complex clinical programs.
• Independently motivated, detail-oriented, and proactive.
• Excellent communication skills.

Benefits

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