VP of Clinical Operations

Lumicity; Minneapolis, Saint Paul (MN, MN); On-site; USD 210,000 - 320,000; Full time

Job summary

Lumicity in Minneapolis seeks a Vice President of Clinical Operations & Affairs to lead clinical strategy, evidence generation, and execution as the company advances an innovative therapeutic platform through development and commercialization.

The role sits at the intersection of clinical development, regulatory strategy, medical affairs, and commercialization, driving physician engagement, regulatory readiness, and strategic clinical programs with a strong rheumatology network.

Qualifications

• Significant leadership in clinical affairs within the medical device/therapeutic technology sector.
• Experience designing and executing prospective clinical studies.
• Familiarity with FDA submissions and regulatory approvals.

Responsibilities

• Own and drive the overall clinical development and clinical affairs strategy from feasibility to post‑market evidence generation.
• Lead design, planning, and execution of clinical studies for regulatory submissions and commercialization.
• Build and maintain relationships with rheumatologists, KOLs, investigators, and academic medical centers.

Job description

Vice President, Clinical Operations & Affairs

Location: Minneapolis–Twin Cities Area, MN

Industry: Medical Device / Therapeutic Technology

Level: Vice President

The Opportunity

A rapidly growing medical technology company in the Minneapolis–Twin Cities area is seeking a Vice President of Clinical Operations & Affairs to lead clinical strategy, evidence generation, and clinical execution as the organization advances an innovative therapeutic platform through development and commercialization.

This is a highly visible leadership role sitting at the intersection of clinical development, regulatory strategy, medical affairs, and commercialization. The VP will work closely with executive leadership and cross-functional partners to shape clinical programs, build relationships with key physicians and investigators, and establish the clinical evidence required to support regulatory approvals, physician adoption, and future indications.

Experience within rheumatology is a major priority for this search. The ideal candidate will bring a strong understanding of rheumatologic diseases, clinical trial design within the therapeutic area, and an established network of rheumatology Key Opinion Leaders (KOLs), investigators, and clinical experts.

Key Responsibilities

• Own and execute the company's overall clinical development and clinical affairs strategy, from early feasibility through pivotal studies and post‑market evidence generation.
• Lead the design, planning, and execution of clinical studies supporting regulatory submissions and commercialization.
• Develop clinical strategies for new indications and broader applications of the company's technology.
• Build and maintain strong relationships with leading rheumatologists, KOLs, clinical investigators, academic medical centers, and physician advisors.
• Leverage an existing rheumatology network to identify investigators, establish advisory relationships, strengthen clinical programs, and accelerate physician engagement.
• Establish and manage Clinical Advisory Boards and other physician engagement initiatives.
• Work directly with investigators and clinical sites to ensure successful study execution, enrollment, data quality, and adherence to protocols.
• Partner closely with Regulatory Affairs to ensure clinical programs are designed to meet FDA and other applicable regulatory requirements.
• Translate clinical and scientific data into compelling evidence for regulators, physicians, partners, and other external stakeholders.
• Partner with R&D, Regulatory, Quality, Medical Affairs, and Commercial teams to ensure clinical priorities are aligned with the broader product strategy.
• Evaluate clinical evidence, competitive technologies, treatment pathways, and unmet needs within rheumatology to inform future development programs.
• Oversee clinical vendors, CROs, consultants, investigators, and external research partners as appropriate.
• Establish scalable clinical operations processes, systems, and infrastructure as the organization and clinical portfolio grow.
• Represent the clinical organization with executive leadership, external advisors, investigators, and strategic partners.

Rheumatology & KOL Leadership

A central component of this role will be establishing credibility within the rheumatology community.

The ideal candidate will have:

• Meaningful professional experience working within rheumatology, autoimmune disease, inflammatory disease, or closely related therapeutic areas.
• A strong understanding of rheumatology treatment pathways, clinical endpoints, patient populations, and clinical study considerations.
• Existing relationships with rheumatology KOLs and investigators, particularly physicians involved in clinical research and emerging therapies.
• Experience developing and maintaining long‑term relationships with influential physicians, academic researchers, and clinical institutions.
• The ability to identify and engage the right investigators and advisors to support clinical development and future commercialization.
• Credibility discussing clinical evidence and study strategy directly with physicians and scientific leaders.

Candidates who combine medical device clinical leadership with a deep rheumatology network will be particularly compelling.

Ideal Background

• Significant clinical affairs, clinical development, or clinical operations leadership experience within the medical device, biotech, or therapeutic technology industry.
• Previous leadership at the Director, Senior Director, Vice President, or equivalent level.
• Demonstrated experience designing and executing prospective clinical studies.
• Experience supporting clinical programs used for FDA submissions and regulatory approvals.
• Strong understanding of Good Clinical Practice (GCP), clinical research requirements, and regulated product development.
• Experience working with physician investigators, KOLs, academic medical centers, and clinical research sites.
• Demonstrated ability to lead complex, cross‑functional clinical programs from strategy through execution.
• Experience working within an emerging or growth‑stage organization where leaders are expected to operate both strategically and hands‑on.
• Strong executive communication skills with the ability to communicate clinical strategy to technical, regulatory, commercial, and executive audiences.

Particularly Relevant Experience

Candidates may come from organizations developing:

• Rheumatology or autoimmune disease therapies
• Medical devices used within rheumatology
• Neuromodulation or energy‑based therapeutics
• Non‑invasive therapeutic technologies
• Interventional or therapeutic platforms requiring significant physician engagement
• Technologies requiring development of new clinical evidence and treatment paradigms

Leadership Profile

This position is best suited for a clinical leader who is comfortable building rather than simply inheriting a mature clinical organization. The successful candidate will be able to move seamlessly between executive‑level clinical strategy and the practical details required to move studies forward.

They should bring strong scientific and clinical judgment, an ability to build trust with physicians, and the network and credibility to establish meaningful relationships with the rheumatology KOL community.

This is an opportunity to play a central role in shaping the clinical strategy of an emerging therapeutic technology and building the evidence base needed to bring it to a broader population of patients.