Associate Director, Clinical Operations

Artiva Biotherapeutics•San Diego, CA

5d•$190,000 - $200,000•Onsite

About The Position

The Associate Director, Clinical Operations will manage clinical trials as part of the clinical operations team. They will be involved in the daily operations of Artiva’s clinical programs through vendors. This person may lead a small team of clinical operations professionals and will be expected to provide vision, leadership, and mentoring to their assigned team. The role requires an excellent understanding of Autoimmune and Cell Therapy trials. They must have strong problem solving and communication skills and be able to deal with evolving and complex business problems. They need to be able to bring recommendations to management and support strategic analysis affecting programs and priorities. They must facilitate effective internal and external relationships, and they are responsible for the achievement of project goals.

Requirements

Bachelor’s degree in a life science related field or equivalent work experience strongly preferred. An advanced degree in a life science discipline is strongly preferred.
Experience in Cell Therapy, Autoimmune or Rare Disease is strongly preferred
A minimum of 10 years’ relevant industry experience, including CRO/vendor management, with expertise in clinical operations leading early through late-stage clinical trials
Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations.
Demonstrated experience managing and mentoring clinical team members, in a matrix environment.
Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
Must have extensive experience managing CROs, central laboratories, and other clinical study vendors.
Must have a working knowledge of data management, data review and analysis, and drug safety and pharmacovigilance.
Ability to work on and solve complex problems.
Ability to prioritize and handle multiple tasks simultaneously.
Effective leadership skills and proven ability to foster team productivity and cohesiveness.
Excellent communication/interaction skills and experience in a dynamic and growing organization.
Ability to travel, up to 25%, includes the possibility of international travel.

Responsibilities

Manage complex Phase 1, 2, 3, and 4 clinical trials as part of the Artiva Clinical Operations team.
Demonstrate oversight of CROs and work in a quality framework that supports early and confirmatory trials
Provide direction and leadership in CRO and vendor selection and management.
Knowledge of regulatory start up process and planning in support of study start up
Building, managing, and maintaining high performing clinical teams
Contribute to strategic planning to ensure optimized clinical development plans for assigned projects. Inclusive of this is enrollment modelling to support scenario planning for portfolio optimization and spend/timeline analysis.
Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Project Management and Regulatory to ensure operational excellence.
Be responsible for, and manage, clinical research activity of Clinical Trial Managers and other staff.
Prepare clinical research budgets and timelines. Manage trial budgets, spend analysis and accuracy in partnership with management and Artiva finance teams.
Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs
Work with departmental leadership and Quality to identify and improve Artiva SOPs.
Responsible for preparing Requests for Proposals documents (RFP’s) and soliciting bids from CROs and vendors, evaluating the submitted proposals for merit and fit, and developing a rationale for selecting a preferred vendor with the Clinical Operations Team.
Accountable for the management of vendor agreements for outsourced activities, including vendors’ adherence to the scope of service agreements, budgets, plans and timelines, ensuring that change orders to the work scope and budgets meet clinical operations specifications.
Responsible for driving a feasibility process leading to a collaborative evaluation and selection of clinical trial sites.
Responsible for driving enrollment efforts to deliver the program.