Kenai Therapeutics (Kenai) is a biotechnology company pioneering next generation approaches to cure neurological conditions. The Company utilizes induced pluripotent stem cell (iPSC) technology, a Nobel Prize-winning breakthrough that enables scientists to manufacture any human cell, to generate Kenai's off-the-shelf neuron replacement therapeutics. By focusing on an iPSC technology platform, and forging partnerships with global leaders in surgical delivery and clinical development, Kenai is dedicated to advancing a best-in-class pipeline targeting neurological conditions. Kenai Therapeutics closed an $82 million Series A financing in 2024, co-led by Alaska Permanent Fund Corporation, Cure Ventures and The Column Group, with participation from Euclidean Capital and Saisei Ventures.

Reporting to the Chief Medical Officer (CMO), the Vice President of Clinical Operations is a senior leadership position responsible for overseeing and advancing all clinical operations activities across the organization. This role will serve as the strategic and operational leader, ensuring the successful execution of clinical trials, with a focus on meeting project milestones, timelines, and regulatory requirements. The VP of Clinical Operations will collaborate closely with executive leadership, functional heads, and external stakeholders to drive the clinical program's success, from early-phase trials through post-marketing surveillance.

Responsibilities

Strategic Leadership:

Develop and execute clinical operations strategies to support company objectives and ensure alignment with the broader business goals.
Collaborate with senior leadership, including the CMO, to shape and execute the clinical development strategy, ensuring it meets regulatory, scientific, and commercial needs.

Clinical Trial Oversight:

Lead the planning, design, and execution of clinical trials, ensuring adherence to timelines, budgets, regulatory standards (GCP/ICH), and quality expectations.
Oversee the creation and execution of critical clinical documents, including study protocols, clinical study reports, investigator brochures, and safety monitoring plans.

Resource and Vendor Management:

Develop resourcing strategies to support clinical program needs, ensuring adequate and efficient allocation of resources for both internal and outsourced activities.
Identify, select, and manage external vendors, CROs, and other partners, ensuring high performance and adherence to project goals and timelines.

Cross-Functional Collaboration:

Lead and collaborate with other functional areas, including Regulatory Affairs, Medical Affairs, Biometrics, and Research, to ensure integration of project goals and efficient execution of clinical programs.
Provide guidance and support to Clinical Operations teams, shaping department strategy and performance standards.

Stakeholder Engagement:

Serve as a key representative of Clinical Operations in interactions with external stakeholders, including KOLs, patient advocacy groups, regulatory agencies, and vendors.
Ensure the patient voice is integrated into the planning, design, and execution of clinical trials.

Budget and Forecasting:

Oversee the clinical trial budgets, resource allocation, and financial forecasting, ensuring projects are delivered on time and within budget.
Provide regular updates to executive management on the status of ongoing clinical programs and trials.
Regulatory Compliance & Safety:
Ensure that all clinical trials comply with applicable regulatory guidelines, including FDA, EMA, and ICH standards.
Collaborate with the pharmacovigilance team to monitor and evaluate the safety profile of drugs under investigation, ensuring continuous safety monitoring and compliance.

Team Leadership & Development:

Lead, mentor, and develop a high-performing Clinical Operations team, providing coaching, training, and career development opportunities.
Foster a culture of collaboration, quality, and excellence within Clinical Operations and across the organization.

Qualifications

REQUIRED: Experience in cell and gene therapy, deployed for interventional studies in the nervous system
Minimum 15 years of experience in clinical operations, with at least 10 years in leadership roles within the pharmaceutical or biotechnology industry.
A bachelor's degree in life sciences (or related field) is required; an advanced degree (e.g., MBA, PhD) is preferred.
Proven experience in managing both early-phase and late-phase clinical trials, including vendor management and outsourcing.
Strong understanding of regulatory requirements (FDA, EMA, ICH), GCP, and clinical trial design.
Demonstrated success in building and leading cross-functional teams, mentoring staff, and driving organizational change.
Excellent strategic thinking and problem-solving skills, with the ability to navigate complex issues and make data-driven decisions.
Exceptional written and verbal communication skills, with the ability to present complex clinical data and trial parameters to both internal and external stakeholders.
Proficient in Microsoft Office Suite; experience with clinical trial management systems (CTMS) and other clinical development tools is a plus.

Additional Details

This is a remote position open to individuals in the United States, with travel requirements. The role will require travel to clinical study sites and external vendors as needed to manage relationships and to provide technical and project oversight, as well as periodic face-to-face team meetings. The travel time is expected to be roughly 25% of total working hours.

The salary range for this position is $270,000 USD to $305,000 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.

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VP, Clinical Operations