Associate Director/Director, Clinical Operations - 858 Therapeutics, Inc.

Associate Director/Director, Clinical Operations

858 Therapeutics, Inc.

San Diego, CA 92121

About 858 Therapeutics, Inc.

At 858 Therapeutics, we are advancing a portfolio of small molecule drugs that act on novel therapeutic targets in oncology. Our programs are focused on important nodes in cancer biology, including DNA damage repair, innate immunity, and RNA epigenetics. We leverage our deep expertise in structure-based drug discovery and translational research to develop differentiated drug candidates. 

Position Overview

The Associate Director/Director of Clinical Operations is a critical team member as we transition to a clinical stage company in 2024, filing the IND on our lead program ETX-19477, a PARGi, this year.  The Associate Director/Director of Clinical Operations will be responsible for the planning, implementation, execution, and management of the ETX-19477 phase 1 clinical study by overseeing day-to-day operations and directly managing and working with outside Clinical Research Organizations and academic institutions. The candidate must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. The successful candidate will be enthusiastic to work with a deep discovery organization and be able to analyze complex issues and pull cross functional team members together to develop relevant and realistic plans and recommendations. Excellent written and verbal communication skills, strong problem-solving ability, and attention to detail and quality are critical to success.

Primary Responsibilities:

• Build and lead Clinical Operations functions and infrastructure for our organization; staffing as appropriate for clinical development and company needs, including oversight of clinical operations consultants.
• Build and manage clinical study budget and timelines.
• Build and manage internal SOPs and controlled documents in accordance with GCP and risk management
• Recommend, implement and manage clinical outsourcing strategy for all clinical programs, including geostrategy considerations and site evaluation for biomarker directed oncology studies
• Oversee and monitor the management of clinical studies ensuring they are conducted in compliance with the agreed study plans and all applicable regulations and requirements.
• Monitor progress of clinical activity and report on the progress of assigned clinical trials including budget, timelines, and clinical data collection.
• Manage escalation of study related issues and communicate to internal stakeholders and external CROs as appropriate.
• Anticipate potential study issues and to prepare contingency plans with minimal oversight.
• Manage and oversight of PDx translational vendors, including biospecimens logistics and partnering with functional leads to ensure quality data are generated and integrated into the clinical study database
• Plan and communicate with cross-functional team members to ensure proper initiation, execution, and conduct of clinical trials and generation of high-quality clinical data.
• Serve as a primary point of contact and resource for clinical operations activities for CROs, vendor personnel, investigator site personnel, and other team members.
• Review and approve study-related plans generated by CROs and vendors, and ensures the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
• Participate in the authoring, review, and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions, and other publications as required.
• Coordinate the delivery of clinical trial supplies in collaboration with CRO and other team members.
• Request and critically evaluate proposals and change orders from CROs, vendors, and investigator sites (as applicable).

Qualifications:

• Requires a bachelor’s degree or equivalent, preferably in a science or health related field (advanced degrees desirable for director) with at least 5 years prior leadership and oncology study experience, and full study lifecycle experience (e.g. start, conduct, closure). 
• Experience in phase I-III clinical studies. Global experience necessary.  Experience in phase 1 oncology studies preferred.
• Understands and ensures adherence to SOPs, ICH/GCP, and FDA and other health authorities’ regulations, with strong understanding of inspection readiness.
• Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection, and reporting, and understands preparation of regulatory submissions
• Demonstrated experience in study management/monitoring/risk monitoring, as well as working and negotiating with CROs, including issue mitigation.
• Demonstrated ability to work independently and lead effectively, with exceptional organization and attention to detail.
• Meaningful in office presence is expected to optimally interact and engage with cross-functional team members.  This is a full-time position that offers some flexibility for working from home.

CONTACT: Qualified interested applicants should send a resume and cover letter to hr@8five8tx.com; please reference job posting # 20240206CL.

Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position has a compensation range of $165,000 - $200,000 for an Associate Director role or $180,000 - $240,000 for a Director role.

858 Therapeutics, Inc. is an EEO employer. 

858 Therapeutics, Inc., provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.