Clinical Trial Associate

Kalaris Therapeutics is a clinical stage biopharmaceutical company incorporated in 2019, focused on the development of innovative therapies for the treatment of neovascular retinal diseases.

The standard of care today to treat neovascular retinal diseases such as nAMD and DME is ophthalmic anti-Vascular Endothelial Growth Factor (anti-VEGF) agents, delivered via intravitreal injection. The branded market for these drugs currently stands at $14 billion, and is expected to continue to grow in the years ahead. This class of agent has been the first-line standard of care treatment since the approvals of Macugen and Lucentis over 20 years ago. The subsequent launches of Eylea, and recently Vabysmo, have looked to improve upon the first agents by promising increases in treatment duration, but real-world evidence indicates that these improvements are modest at best. Despite this, Eylea generated $9.4 billion in global sales in 2023, and Vabysmo is projected to sell over $4 billion this year in only its 2nd full year on the market.

The significant treatment burden associated with current regimens represents a major unmet need for therapies with meaningfully longer durability. The burden of current treatments often leads to poor compliance and undertreatment which results in progressive vision loss, thereby highlighting a significant need for therapies with longer-lasting therapeutic effect.

Kalaris has a lead asset, TH103, which is being developed to address this unmet need for meaningfully increased durability. An IND for TH103 was filed earlier this year, and the company recently initiated a Phase I clinical trial which will provide both dosing and safety information in patients, as well as preliminary evidence of the molecule’s therapeutic effect.

Kalaris has assembled a leadership team and board of directors comprised of proven leaders with deep domain experience in the development of ophthalmology treatments, functional expertise spanning the pharmaceutical value chain, multiple launch experiences, and a broad track record of building biotech companies, with several successful exits. The current management team includes individuals with prior C-suite roles, including CEO positions at publicly traded biotech firms and wholly-owned pharmaceutical subsidiaries.

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Kalaris is seeking a Clinical Operations Clinical Trial Associate. This individual will be a key member of the Clinical Operations Team and will contribute to the development, techniques and processes by assisting and helping support the study team across all investigator sites. Based on experience, the CTA assumes responsibility for more complex tasks and applies creative and effective solutions where needed. Typically working on assignments requiring judgement and initiatives, the CTA independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities.

Assist the Associate Director/Director of Clinical Operations in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with quality, in compliance with applicable SOPs and regulatory guidelines.

Job Description and Specific Responsibilities

• Maintaining the Trial Master File (TMF) and assisting with site management, initiating the distribution, collection, handling, reviewing, tracking and archiving of essential documents throughout the lifecycle of clinical studies; this includes managing the filing indexes and maintaining current lists of correspondence; ensures completeness of, conducts regular audits of, organizes and archives clinical Trial Master File documents, including clinical study site documents, email correspondence, training materials and other study documents; participates in TMF or study audits as request and assists with responding to findings.
• Assists the study teams with site communications for various purposes – this includes feasibility/site identification activities and site updates.
• Performs study start-up activities which includes but is not limited to review of informed consents, development and review of study reference plans and manuals; distribute, collect and conduct quality review of clinical study site documents.
• Responsible for the submission of study documents to ethics committee and/or competent authorities; works as a liaison with review boards and independent ethics committees in the regulatory approval process.
• Assists with the creation and maintenance of study-specific documents, tools and materials and the procurement of study supplies.
• Provides study materials and supplies to the study sites and Clinical Research Associates (CRAs).
• Assists with tracking of clinical study progress including the creation and maintenance of study related trackers and status reports.
• Participates in clinical team meetings – coordinates teleconferences / webinar and assists with the preparation of agendas, minutes and tracking of action items.
• Prepares for and attends Investigator Meetings, as required. May participate in clinical vendor selection process, as required.
• Performs review of clinical data listings, as required.
• Maintains completion of company and study-specific trainings such as SOPs, policies, study plans and documents by due date.
• May participate and contribute to the implementation of process improvements to support study teams, department or the company (e.g. SOPs).

The tasks and duties listed above are not all inclusive and Kalaris may assign other responsibilities not listed as per discretion with little or no prior notice.

Qualifications/Experience

• Undergraduate degree or its international equivalent in clinical, science or health-related field.
• Minimum 2 – 6+ years experience in clinical research.
• Prior experience in pharmaceutical, biotechnology or contract research organization (CRO) company preferred.
• Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form.
• Demonstrate high ethical standards for honesty, truthfulness and integrity.
• Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines, as well as basic understanding of the phases of clinical drug development and clinical operation processes.
• Ability to receive general instructions on all new assignments and perform routine work with minimal or no supervision.
• Strong sense of urgency, organizational skills with attention to detail and ability to follow through on assigned tasks.
• Proficiency in computer literacy in several software packages, especially Microsoft Office applications (Word, Excel) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods.
• Enthusiastic team player and ability to work effectively in a team/matrix environment
• Ability to handle multiple tasks and deliver assigned tasks with quality and within specified timelines

This is a hybrid role and will require occasional travel to face-to-face Kalaris meetings. The travel time is expected to be 10% of the total working hours.

The salary range for this position is $73,000 USD to $106,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.