Director, Clinical Scientist

Description

The Director, Clinical Scientist is an integral member of a cross-functional team for a study drug from first in human to registration by providing input and execution of the clinical development plan by helping develop and execute protocols and protocol amendments.

Key Responsibilities

• Perform ongoing clinical data review and analysis to ensure data integrity, identify trends, and support safety and efficacy assessments

• Review and interpret clinical data to identify trends, investigate unexpected findings, and provide meaningful insights to study teams

• Support medical monitoring activities, including review of adverse events, protocol deviations, and long-term safety and efficacy outcomes

• Provide input and execution of the clinical development plan by helping to develop and execute protocols and protocol amendments

• Actively participate in study/site start-up activities, site engagement (including SIVs and committees), and provide general clinical support to the study teams

• Contribute to key clinical and regulatory documents including Clinical Study Reports (CSRs), informed consent form(s), Investigator’s Brochures (IBs), and DSURs

• Serve as a partner to external stakeholders in various countries and help support local needs

• Manage 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 operating 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.

• Provides subject matter expertise on activities or through supporting the design and execution of clinical trials and/or enabling projects across geographies.

• 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.

• 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

• BS/BA with advanced degree preferred

• Oncology and or hematology focus

• At least 5 years of relevant experience either in the pharmaceutical industry, community setting or academia.

• 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 solve complex outcomes; takes a new perspective on existing solutions; exercises judgment based on analyzing multiple sources of information and advice.

• Ability to travel up to 10% of the time domestically or internationally

• Excellent problem-solving skills and proven track record of delivering to aggressive timelines

• High ethical and professional standards, working in accordance with regulations and company policies and procedures

• Proficient use of MS Office (Word, Excel, PowerPoint)