Senior Medical Director

Description

At Kumquat, we strive to develop life changing medicines in an efficient and innovative way with the shared mission of patient focus. The Medical Director plays an essential role in leading the development program of a study drug, innovative clinical trial design, execution of clinical studies with the study management team, and data quality to bring better clinical trials to more patients.

We want you to join our mission and be part of our passionate and collaborative community, we value individual and team accountability and also see the potential of all our people to learn, grow, develop and achieve great things beyond the confines of traditional descriptions.

• Developing protocols and protocol amendments for an oncology product
• Work with cross-functional team to develop eCRFs
• Actively participating in study/ site start-up activities, data review and interpretation, site engagement (including SIVs and committees), and provide general medical support to the study team(s)
• Maintains up-to-date knowledge on the emerging treatment landscape in study specific areas
• Cultivate meaningful peer-to-peer collaborations and nurture a culture of curiosity to enable faster, simpler, and more patient‑centric ways of operationalizing our studies.
• Work with colleagues across Kumquat to promote communication and community. Optimizing growth opportunities and capabilities to successfully contribute and operate in a diverse and global environment. Drive new thinking by identifying new opportunities and options to embrace value creation.
• Ensure GCP/GVP compliance, data integrity, and take a balanced risk‑based approach in the work you are focused on, seeking guidance or direction as needed.
• Provide input into work instructions and SOPs to ensure consistency across programs and ensure efficiency
• Author or support authoring of the clinical development plan for the assigned product
• Work closely with medical safety and clinical scientist, medical monitoring of ongoing clinical trial
• Develop & support product strategy.

• You are a talented and passionate human, inspired by our shared purpose to innovate clinical trial delivery to bring better trials to more patients.
• You thrive in environments of ambiguity and collaboration where the ability to make sound decisions quickly while seeking advice when needed is essential.
• You are an effective communicator that shares information transparently and strategically. You are comfortable working out loud and are an active listener.
• You thrive leading or being an active member of large or small diverse teams.
• Expectations:
• Knowledge of Clinical development such as study design, protocol execution, medical monitoring, data quality and drug development.
• Provides subject matter expertise on activities or through supporting the design and execution of clinical trials and/or enabling projects
• Contributes to the outcome of one or more clinical trials and/or enabling projects.
• Understands, applies proficient knowledge of, and ensures adherence to ICH, GCP, and regulatory guidelines within clinical trials or enabling activities.
• Builds relationships with sites and investigators and partners to ensure the execution of clinical trials.

• MD/DO required
• Oncology and or hematology experience as practicing physician preferred
• Minimum of 5 years of relevant experience in the pharmaceutical industry in clinical development, biotech experience preferred.
• Phase 1 study trial experience in either solid tumor or hematologic malignancies with a focus on small molecules preferred
• Working knowledge of Drug Development and Clinical development activities and deliverables.
• Ability to travel up to 10% of the time domestically or internationally
• Able to work remote or hybrid

We invite candidates one level junior or senior to this level- such as Director or Executive Director to apply as well. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.

$283k- $357k