What are the responsibilities and job description for the Early Phase Development Senior Executive VP Medical Director position at Kumquat Biosciences Inc?
Job Description
Job Description
Description :
At Kumquat, we strive to develop life changing medicines in an efficient and innovative way with the shared mission of patient focus. The Executive 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 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.
Medical Director :
Will report to VP of Clinical Development or CMO depending on experience
Leading a cross functional team for a study drug from the first in human study by :
Providing clinical and strategic input to senior management.
Overseeing and being accountable for design and execution of the clinical development plan by developing and execution of studies and data driven decision making to shape life cycle of the program
Engaging effectively with key thought leaders and investigators
Actively participating in study / site start-up activities, data interpretation and provide general clinical support to the study team(s)
Serve as a partner to external stakeholders in various countries and help support local needs.
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. Work closely with preclinical and drug discovery to exchange ideas
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.
Who you are :
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 apply your organizing and problem-solving skills to run efficient teams
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 and drug development especially in First in Human and early phase development.
Provides subject matter expertise on activities or through supporting the design and execution of clinical trials and / or enabling projects across geographies.
Independently and with minimal guidance develops plans to support the design and execution of 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.
Participates in identifying vendors, builds relationships with sites and investigators and partners to ensure the execution of clinical trials.
Work closely with Investigator and clinical site staff
Requirements :
MD or MD / PhD with oncology and or hematology expertise
At least 4 years of relevant experience in early development either in the pharmaceutical industry, community setting or academia.
Phase 1 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 solve complex outcomes; takes a new perspective on existing solutions; exercises judgment based on analyzing multiple sources of information and advice.
Ability to explain complex information to others in a straightforward manner
Ability to travel up to 25% of the time domestically or internationally
Must reside in San Diego and must come into office at least 3 times a week
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