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Medical Director, Early Phase Clinical Development (Senior or Executive Level)

Kumquat Biosciences Inc
locationSan Diego, CA, USA
PublishedPublished: 6/14/2022
Healthcare
Full Time

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

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