Commercial Operations Sr Manager/ Associate Director, MLR & Meetings

Posted 3 Days Ago
Be an Early Applicant
Hiring Remotely in USA
Remote
Senior level
Biotech
The Role
Own the end-to-end Medical, Legal, and Regulatory review process for commercial materials, including workflows, timelines, approvals, reporting, and asset lifecycle management in Veeva PromoMats. Coordinate commercial meetings, conferences, sponsorships, vendors, budgets, logistics, and compliance activities. Develop operational processes, KPIs, SOPs, and training while partnering across Marketing, Medical, Legal, Regulatory, Market Access, Sales, and Commercial Operations.
Summary Generated by Built In

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.

The national salary range for this position is $175K to $205K USD annually.  The salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock plan. 

Skills Required

  • Bachelor's degree
  • 4+ years of experience in pharmaceutical, biotechnology, medical device, or another highly regulated industry
  • Experience supporting Medical, Legal, and Regulatory review processes
  • Hands-on experience with Veeva PromoMats or Veeva Vault
  • Experience coordinating corporate meetings, commercial meetings, or events
  • Strong project-management and organizational skills with the 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
  • Comfort operating in a fast-paced, evolving biotechnology environment
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The Company
HQ: Emeryville, CA
55 Employees
Year Founded: 2018

What We Do

Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Using its SmarTcell™ approach which includes synReg-T cell and synNotch CAR-T technology platforms, Kyverna reprograms T cells to target and selectively suppress or eliminate autoreactive immune cells. The company’s goal is to develop therapies that are selective, potent and durable to tame autoimmunity. We build interdisciplinary teams that bring a broad range of experiences and scientific expertise together to develop medicines that will free patients from the siege of autoimmune diseases and bring curiosity for exploring and creating the unknown. Our commitment to our employees is to foster an open, supportive, and inclusive environment where we create opportunities for individuals to learn and grow to their full potential at every level. synNotch is a trademark of Gilead/Kite.

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