Director/Associate Director, Clinical Operations (Asset Lead, EGFR)
The Clinical Operations Asset Lead (Director/Associate Director) is a key member of the Clinical Operations team leading the successful execution of clinical trials. The Clinical Operations Asset Lead provides trial operational oversight of CROs and vendors (including both U.S. and Ex-U.S. regions) and is responsible for all aspects of Phase I through III clinical oncology trials. This role also assures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
- Responsible for growing and managing projects, employees, and daily work activities for the Clinical Team.
- Independently manage all components of complex oncology clinical trials, leading a cross-functional management team.
- Ensure clinical trial activities and deliverables are completed on-time and within budget.
- Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines, and organizational objectives of individual protocols/programs.
- Involved in the identification, evaluation, selection, and oversight of all clinical trial sites.
- Develops strong vendor relationships and ensures continuity of relationships through all phases of the trial.
- Partner efficiently and effectively with clinical trial sites to ensure smooth study conduct.
- Ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites.
- Manages vendors through issue resolution.
- Obtains and maintains in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.
- Oversee and participate in development of study documents and tools including study protocols, consent forms, and project plans.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.
- Participates in Site Initiation Visits.
- Develop processes and provide oversight of study supplies management.
- Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.
- Oversee ongoing study data reviews and data cleaning activities.
- Responsible for inspection readiness at all times. Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
- Works with vendors to revise scope of service agreements, budgets, plans, and detailed timelines, and ensure that performance expectations are met.
- Supports financial management of the study which includes review and approval of site and vendor invoices.
- Supports Risk Management initiatives.
- Supports audit/inspection activities as needed.
- Maintain clinical trial registry entry/updates, as required.
- Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements.
- Conduct/attend internal/external meetings for assigned clinical trials.
- Provide study status updates, including presentations and reports to senior management.
- May develop SOPs, best practices, and facilitate their implementation.
- May perform periodic oversight visits of sites and/or vendors to assess progress and compliance.
- Other activities as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES
- BA/BS in related scientific or healthcare field; a combination of relevant education and applicable job experience may be considered.
- 8-10 years of clinical trial management experience.
- Experience in running a trial from start to finish; initiating the trial; ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.
- Excellent communication skills, including the ability to understand and present technical information effectively.
- Strong understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP, FDA regulations, & country clinical research law & guidelines.
- Strong understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Demonstrated ability to mentor/lead.
- Strong leadership, effective decision making, and problem-solving skills required.
- Hands-on knowledge of Good Documentation Practices.
- Performs independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites, and therapeutic areas.
- Strong IT skills (Use of MS office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to understand and analyze data/metrics and act appropriately.
- Possesses effective time management, organizational and interpersonal skills, conflict management, problem-solving skills.
- High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works effectively in a matrix cross-functional environment. Ability to establish and maintain culturally sensitive working relationships.
- Works with high quality and compliance mindset.
- Previous oncology experience required and experience with solid tumors and immunotherapy/biologics preferred.
- Ability to travel up to 15%.
Compensation:
In addition to a competitive compensation package with stock options and stock purchase plan, Janux also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance is also available.
Job Type: Full-time
Benefits:
- 401K
- Medical insurance
- Dental insurance
- Vision insurance
- Supplemental disability insurance plans
- Flexible schedule
- Life insurance
- Flexible vacation
- Sick time
- Incentive stock option plan
- Relocation assistance
Schedule:
Work authorization:
Additional Compensation:
Work Location:
COVID-19 Vaccination required
Janux requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Janux will consider requests for Reasonable Accommodations.
EQUAL OPPORTUNITY EMPLOYER:
Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
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