Medical Director, Early Phase Clinical Development (Senior or Executive Level)
Job Description
Job DescriptionDescription:
At Kumquat, our mission is to bring meaningful medicines to patients through science, efficiency, and innovation. The Medical Director is a key partner in this effort—guiding the development of study drugs, shaping thoughtful clinical trial designs, and working closely with study teams to deliver high-quality trials that truly serve patients.
We invite you to join our mission and become part of a passionate, collaborative community. We believe in shared accountability and in the potential of every team member to learn, grow, and achieve more than what’s defined in a job description.
The Medical Director will report to the SVP of Clinical Development and lead a cross-functional team for one or more study drugs by:
- Providing general clinical and strategic input to senior management.
- Collaborating closely with preclinical and drug discovery teams to exchange insights, providing clinical expertise and guidance on the development and clinical advancement of new molecules.
- Designing clinical development plans.
- Lead or contribute, as applicable, to the development and review of all study conduct-related documents, ensuring they are accurate, clear, and aligned with protocol and regulatory standards.
- Leading engagement with regulatory authorities in a clinical capacity, representing the company as a medical expert in meetings, briefings, and official communications.
- Actively contributing to study and site start-up activities.
- Overseeing and executing clinical studies for one or more drugs, ensuring accountability for their successful conduct in alignment with the clinical development plan.
- Interpreting clinical data from ongoing studies, ensuring accurate analysis and providing medical insight to guide study conduct and decision-making.
- Proactively engaging and building strong relationships with key opinion leaders and clinical investigators.
- Acting as a proactive partner to external stakeholders across multiple countries, providing support for local needs and priorities.
- Stay current on emerging treatments and developments relevant to the company’s interests and study-specific therapeutic areas.
- Cultivating meaningful peer-to-peer collaborations and nurturing a culture of curiosity to enable faster, simpler, and more patient-centric ways of operationalizing our studies.
- Working with colleagues across Kumquat to promote communication and community.
- Ensuring GCP compliance and data integrity, applying a balanced, risk-based approach while seeking guidance or direction as appropriate.
Who You Are:
- A talented and passionate professional, inspired by our shared purpose to innovate clinical trial delivery and bring better medicines to more patients.
- Comfortable thriving in environments of ambiguity and collaboration, making sound decisions quickly while seeking advice when needed.
- Skilled in organizing and problem-solving to run efficient teams.
- An effective communicator, sharing information transparently and strategically.
- Comfortable working openly and actively listening to colleagues.
- Experienced in leading or being an active member of large or small, diverse teams.
- Collaborative and humble, valuing team input, continuous learning, and shared success while contributing expertise and guidance.
Expectations:
- Knowledge of clinical development, including study design, protocol execution, and drug development—especially early-phase clinical development.
- Provides subject matter expertise by supporting the design and execution of clinical trials and/or enabling projects across geographies.
- Independently develop plans, with minimal guidance, to support the design and execution of clinical trials and/or enabling projects.
- Applies proficient knowledge of, and ensures adherence to, ICH, GCP, and regulatory guidelines within clinical trials or enabling activities.
- Participates in identifying vendors, building relationships with sites and investigators, and partnering to ensure the execution of clinical trials.
- Works closely with investigators and clinical site staff.
Requirements:
- MD or MD/PhD with oncology and/or hematology expertise.
- At least 3 years of relevant experience in early development within the pharmaceutical or biotech industry.
- Phase 1 trial experience in solid tumors or hematologic malignancies, with a preferred focus on small molecules.
- Working knowledge of drug development and clinical development activities and deliverables.
- Ability to solve complex problems, take new perspectives on existing solutions, and exercise judgment based on analyzing multiple sources of information.
- Ability to explain complex information clearly and effectively.
- Willingness to travel up to 25% domestically or internationally.
Salary Description: $350k - $385k