Sr. Director, Clinical Operations

About Artiva:

Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Our lead program, AlloNK, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers. AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed's innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.

We are seeking a strong, experienced Sr. Director for Clinical Operations to join our team in San Diego. As a Sr. Director, Clinical Operations, you will be an essential member of the clinical team, reporting to the SVP, Clinical Operations.

Duties/Responsibilities:

• Responsible for ongoing assessments of available resources, and the appropriate deployment of those resources to execute corporate priorities, as provided by the Executive Committee.

• Responsible for the implementation of clinical trial operational plans factoring in timelines, budgets, and resource requirements.

• Responsible for the implementation of risk mitigation plans to ensure clinical trials are conducted on time, within budget, and in compliance with all applicable cGCP and ICH requirements.

• 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.

• Responsible 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 evaluating and selecting clinical sites for participation in studies, including assessing sites' feasibility, quality and fit to ensure enrollment timeline and budget requirements are met. As required and appropriate, engaging with site Investigators or Study Coordinators to facilitate the site's success in meeting subject enrollment and/or data submission goals.

• With the Senior Vice President of Clinical Operations, drive consistency and operational excellence in all forms of clinical documentation and behavior.

• Responsible for the review of invoices for accuracy compared to operational plans, budgets and study progress by sites/CROs/vendors.

• Working with the Finance Team, prepare cost projections and budget forecasts for the engagement of contractors, CROs, clinical sites, and vendors in the execution of clinical trials.

• Manage a productive relationship with CROs, vendors, and clinical sites to support clinical operations goals and objectives.

• Supervise the activities of Clinical Trial Managers and other Clinical Operations Team members to ensure efficient processes from study initiation, planning, execution, and maintenance through to close-out.

• Ensure that all study related documents are completed and applied to the conduct of the clinical studies (e.g., Monitoring Plans, CRF Completion Guidelines, etc.)

• Responsible for the training of internal and external Team members, ensuring compliance with the study protocol, corporate SOPs and GCP/ICH regulatory guidelines.

• Provide project management leadership for clinical and related disciplines.

• Responsible for overseeing clinical logistics including the distribution of the investigational product, required supportive products/ administration materials, and the coordination of study sample collection, and data reporting.

• Responsible for the submission of periodic reports to the Senior Vice President of Clinical Operations as directed, that track each project in terms of actual costs vs. budget, subject enrollments, data acquisition/cleaning, major project milestones and timelines, identified risks/mitigation strategies and other issues that may arise.

• Responsible for timely responsiveness of queries from internal and external stakeholders

• Work with the Senior Vice President of Clinical Operations in the annual review of SOP's and other collateral clinical documents, developing new or improved processes as needed to ensure operational excellence.

Requirements:

• Bachelor's degree in a life science related field or equivalent work experience. An advanced degree in a life science discipline is strongly preferred.

• A minimum of 15 years' relevant industry experience, including CRO/vendor management, with expertise in clinical operations leading early through late stage clinical trials.

• Proven knowledge and experience with ICH/GCP guidelines, FDA and EMA regulations, clinical quality and regulatory standards is required. Experience in conducting international clinical studies is preferred (Especially in EU and Asia Pacific/Australasia countries).

• Autoimmune diseases and/or oncology experience is required. Cell therapy experience is strongly preferred.

• Proven knowledge and relevant experience in the development and implementation of Clinical SOP's, Clinical Study Reports, INDs and other clinical, regulatory and safety documents.

• Superior oral and written communication skills, and the ability to work effectively with senior management, are required.

• Relevant experience and demonstrated ability to work effectively with internal stakeholders, collaborators, and clinical sites.

• Creativity, passion, and independent thinking are highly valued.

• Ability to travel up to 25%, including the possibility of international travel.

If all this speaks to you, come join us on our journey!

Artiva Biotherapeutics is an equal employment opportunity employer.

Base Salary: $234,000 - $265,000. Exact compensation may vary based on skills and experience.