VP/Senior Director Clinical Operations - San Mateo, United States - TriArm Therapeutics
Description
Background
TriArm Therapeutics is a clinical-stage biotechnology company that is advancing CAR T cellular therapy with novel platforms that are designed for enhanced safety, efficacy, and accessibility compared to conventional autologous CAR T therapies. Our key platform, Fast in Time (FITTM), involves rapid manufacturing of autologous CAR T cells, with key assets in development for solid/hematologic cancers and autoimmune diseases.
Triarm is looking for an exceptional individual with CAR T cellular therapy experience to serve as the Clinical Operations Lead. The candidate will report directly to the Head of Clinical Development and lead key responsibilities for the Clinical Operations department. Depending on experience, the position title may be Director, Senior Director, or Vice President.
Responsibilities
The Clinical Operations Lead will support US clinical operations activities related to our cellular therapy programs, including the planning, development, and execution of clinical trials, overseeing of CRO partner activities, development of clinical trial documents, and operational/financial forecasting. We are looking for a candidate who is experienced in cell therapy drug development in a biotechnology setting. This is a critical position that will play a key role in establishing and maintaining effective relationships with CRO and cross-functional partners. The candidate will also work closely with Head of Clinical Development to develop the long-term global clinical strategy and vision for our cell therapy products in development.
Specific responsibilities for the Clinical Operations Lead may include the following:
• Oversee CRO/vendor/site selection process, including negotiating contracts/budgets and managing external vendor deliverables/reports/budgets
• Participate in CRO study-related calls and meetings, track actions, escalate issues, and oversee aspects of daily study operations.
• Identify issues/risks, develop mitigations, and escalate risks appropriately
• Define budget, project timelines & deliverables in alignment with other cross-functional team members
• Collaborate in the preparation and/or review of study-related documents (e.g., protocol, ICF, Study Operations Plan, Monitoring Plans, etc,)
• Develop new work streams, study templates, tracking tools, and dashboards to optimize clinical operation performance
• Develop and implement cross-site department policies, processes, and SOPs in accordance with GCP and regulatory guidelines
• Ensure audit-ready conditions of clinical trial documentation, including central clinical files; prepare and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections
• Ensure that clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs
• Provide study-specific training and leadership to clinical research staff, including CRO, sites and other contract personnel
• Build a team and maintain strong leadership while supporting the professional development of new hires
QUALIFICATIONS:
• Bachelor's degree with a minimum of 10+ years of related work experience in the biotech/pharma industry with 5+ years of managerial experience developing and leading a team
• Solid track record in developing cell therapy products
• Experience in working with and overseeing Contract Research Organizations (CROs) and other external vendors
• Project Management and regulatory authority inspection experience preferred
• Relevant knowledge of CMC, QA, clinical and nonclinical science
• Strong leadership skills in leading teams, complex projects, or strategic initiatives
• Strong communication, strategic thinking, and problem-solving skills along with strong presentation skills
• Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities
• Excellent team player; willingness and ability to fill functional gaps in a small organization
• Embodies the traits and behaviors of an impactful leader, including excellent communication, collaboration, coaching, and organizational skills
Salary will be competitive with the industry. This position is also eligible for bonus, benefits, and participation in Company's stock option plan. The position will be based in Triarm's office is located in San Mateo, California).
Triarm Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Triarm is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.