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 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 of a clinical development program. The Senior Medical Director/Medical Director Clinical Development leads 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 Director reports to the Chief Medical Officer or senior clinical leader will play a critical role in developing and executing the ongoing clinical trial strategies for our Oncology products
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
- 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 execution of each assigned study.
- Work with multidisciplinary team to support data cleaning and database lock activities.
- Work with multidisciplinary teams to ensure quality oversight of the study (quality, regulatory, and safety).
- Contribute to the development of clinical sections for regulatory submissions.
- 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).
- Develop working relationships with key investigators in the oncology area to maximize scientific quality in clinical study design, execution, reporting, and publication.
- Contribute to the development of clinical sections of regulatory documents (i.e., Investigators’ Brochures, safety updates, IND/BLA submission documents, responses to Health Authorities questions).
- Contribute to trial-related advisory boards, investigator meetings.
- Work with CRO data management and clinical sub-team to ensure data integrity and quality analysis of a study and planned/actual filing activities as required.
- Serve as the external clinical “face” of the program in interactions with investigators, development partners, and advisory boards as needed.
- Collaborate with other functions to support regulatory submissions (i.e., Breakthrough/FastTrack Designation, pre-IND an IND submission for new drug candidates).
- Promote consistent first line medical/clinical data review techniques and conventions across studies/programs; Review clinical data review plan and author medical monitoring plan for assigned studies/program.
Education and Skill Requirements/Qualifications
- MD/PharmD/PhD or equivalent is preferred.
- Minimum of 6 years of oncology clinical drug development experience, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws.
- Experience in oncology, antibody drug conjugates experience preferred.
- Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously.
- Ability to successfully engage and work collaboratively with cross functional team members
- 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.
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.