Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Title: Commercial Operations Sr Manager/ Associate Director, MLR & Meetings
Reports to: VP, Commercial Operations
Location: Remote (West coast hours preferred)
Position Summary
The Commercial Operations Senior Manager/Associate Director, MLR & Meetings will play a critical role in supporting the efficient execution of commercial activities, with approximately 75% of the role focused on managing and overseeing the Medical, Legal, and Regulatory (MLR) review process. The remaining responsibilities will focus on coordinating key commercial meetings, events, and related initiatives to support cross-functional commercial execution.
Responsibilities
Medical, Legal & Regulatory Review Management
Serve as the operational owner and manage the end-to-end MLR review process for promotional and non-promotional materials, from initial submission through final approval and asset retirement.
Partner closely with Marketing, Medical, Legal, Regulatory, Market Access and other cross-functional stakeholders to maintain a disciplined, compliant and efficient review process.
Serve as the primary operational point of contact for materials moving through the MLR review process.
Route materials to appropriate Medical, Legal, Regulatory and other reviewers based on established workflows.
Manage review timelines, monitor materials throughout the review cycle and proactively identify potential delays or bottlenecks.
Coordinate MLR review meetings, including development and management of agendas, prioritization of materials and communication of review expectations.
Track comments, decisions and required revisions to ensure materials progress efficiently through subsequent review cycles.
Facilitate resolution and escalation of materials or process issues when timelines, reviewer alignment or other issues require additional attention.
Partner with material owners and reviewers to improve submission quality and reduce unnecessary review cycles.
Maintain visibility to the MLR pipeline and provide regular reporting on submission volume, status, cycle times, upcoming expirations and outstanding actions.
Veeva PromoMats & Asset Management
Serve as a key business administrator and subject matter resource for Veeva PromoMats.
Maintain accurate asset records, metadata, approval documentation and version control.
Manage the lifecycle of approved materials, including expiration, extension, reapproval, withdrawal and retirement.
Maintain the commercial asset library and ensure field-facing teams have access to current, approved materials.
Support development and refinement of PromoMats workflows, business rules, reporting and user processes.
Coordinate with system administrators and IT as needed to address system issues and implement process enhancements.
Support onboarding and training of new users on MLR processes and Veeva PromoMats.
Meetings & Events
Ownership of conference logistics across Kyverna, including managing external relationships with industry liaisons at the associations and partnering closely with Marketing and Med Affairs on sponsorship opportunities.
End-to-end conference coordination sponsorship level responsibilities including booth space planning, attendee registration, partnering with cross-organization Executive Assistants on hotel/location logistics, and managing the internal financial approval process.
Coordinate planning and execution of commercial meetings and events, including national and regional meetings, training meetings, internal business meetings, advisory or customer-facing programs, and congress-related activities as appropriate.
Manage meeting logistics including venues, vendors, attendee coordination, registration, meeting materials, audiovisual requirements, catering and other operational needs.
Develop and maintain meeting timelines, project plans and execution checklists.
Coordinate with internal stakeholders and external vendors to ensure meetings are delivered on time and within budget.
Support contracting, purchase orders, invoice reconciliation and budget tracking associated with meetings and events.
Maintain centralized visibility to the commercial meetings and events calendar to identify scheduling conflicts and opportunities for coordination.
Ensure meeting and event activities are executed consistent with applicable company policies and compliance requirements.
Commercial Operations Support
Partner with Commercial Operations leadership to continuously improve MLR, asset management and meeting-management processes.
Develop standard operating procedures, job aids, templates and other tools to drive consistent execution.
Establish and monitor operational KPIs, including MLR cycle time, first-pass approval rates, asset expiration management and meeting execution metrics.
Support additional Commercial Operations projects and initiatives based on evolving business needs.
Qualifications
Bachelor’s degree required.
4+ years of experience in pharmaceutical, biotechnology, medical device or another highly regulated industry preferred.
Experience supporting Medical/Legal/Regulatory review processes strongly preferred.
Hands-on experience with Veeva PromoMats or Veeva Vault strongly preferred.
Experience coordinating corporate meetings, commercial meetings or events preferred.
Strong project-management and organizational skills with demonstrated ability to manage multiple concurrent priorities.
Ability to work effectively across Marketing, Medical, Legal, Regulatory, Market Access, Sales and other functions.
Strong attention to detail and commitment to process discipline and compliance.
Ability to identify potential issues early, escalate appropriately and drive issues through resolution.
Strong written and verbal communication skills.
Comfortable operating in a fast-paced, evolving biotechnology environment where responsibilities may expand as the organization grows.
