Director, Clinical Operations

Evommune; Palo Alto (CA); Hybrid; USD 200,000 - 260,000; Full time

Benefits offered by this job

Health, dental, vision plans

401(k) plan

Paid parental leave

Life insurance

Disability insurance

Employee referral bonus

Pet insurance

Job summary

Evommune, Inc. in Palo Alto, CA, is seeking a strategic Director of Clinical Operations to lead the execution of clinical trials, manage timelines, resources, and budgets, and coordinate with cross-functional teams across development programs.

The role may supervise staff or manage external partners in a matrixed environment, with hybrid work requiring two in-office days per week and remote work up to three days. Competitive compensation and comprehensive benefits are provided.

Qualifications

• BA/BS in life sciences required.
• 7+ years clinical operations leadership; 10+ years in pharma/biotech.
• Experience leading study execution in a start-up or small biotech.
• Strong regulatory, technical, scientific, operational knowledge of drug development.
• Experience in inflammatory, dermatologic, or pain/CNS indications preferred.

Responsibilities

• Lead and oversee execution of one or more clinical trials according to program timelines and budgets, mitigating risks.
• Select and oversee CROs/ancillary vendors and serve as primary escalation point for issues/deliverables.
• Interact with key clinical trial investigators and sites.
• Contribute to clinical development strategy and operationalization of development plans.
• Develop protocols and CSR documents with scientific/operational accuracy.
• Lead/oversee writing and approval of study protocols, labeling, ICFs, CSR, and related documents.
• Provide input to regulatory sections of documents (IBs, DSURs, IND annual reports).
• Coordinate with internal/external teams to ensure study goals are met and manage budgets.
• Travel as required to ensure trial execution.

Skills

Clinical operations leadership

Project management

Regulatory knowledge

Cross-functional collaboration

Startup/biotech experience

Education

BA/BS degree in life sciences

Job description

About Evommune, Inc.

Evommune, Inc. (NYSE: EVMN) is a clinical-stage biotechnology company focused on developing innovative therapies for immune-mediated inflammatory diseases. Headquartered in Palo Alto, California, with additional operations in New York, NY, Evommune is advancing a differentiated pipeline designed to address the underlying drivers of disease.

Our scientific approach integrates deep immunology expertise with disciplined clinical development to deliver potentially best-in-class therapies for patients with significant unmet medical need. For more information, visit www.Evommune.com.

Work Location:

This hybrid position is currently expected to be in the office two days per week, with the option to work remotely up to three days per week. Occasional additional onsite presence may be required based on business needs or operational priorities.

Our Core Values

Before we dive into the specifics of the role, it's important to highlight the core values that are integral to being a member of the Evommune team. Our values are not just words; they shape our culture, guide our decision-making, and define what it means to be part of our team.

• Together We Win: We champion teamwork, celebrating every achievement as a shared success.
• Guided by Insight: We make data-driven decisions, using our collective experience to shape the future of our business.
• Every Day Matters: We act with urgency to bring transformative therapies to patients by being nimble, decisive, and effective.
• Driven By Excellence: We set a high bar and hold ourselves accountable to deliver exceptional results in everything we do.
• Empowered To Act: We invest in our team and value transparency, fostering trust and a sense of ownership.

We seek individuals who resonate with these principles, as they are essential for thriving in our collaborative, innovative, and dynamic work environment.

The Position

Director, Clinical Operations

Evommune is seeking a strategic, dynamic Director of Clinical Operations to oversee the tactical implementation of our clinical trials, including managing the associated timelines, resources, and budgets. The Director of Clinical Operations is a member of the clinical team and works collaboratively across a cross-functional team supporting the strategy and execution of Evommune’s development programs. This role may directly manage team members and/or oversee consultants and external partners in a matrixed structure.

Key Responsibilities

• Lead and oversee execution of one or more clinical trials according to program timelines and budgets, while proactively mitigating risks related to clinical trial conduct, deliverables, vendor performance, and quality.
• Select and oversee CROs/ancillary vendors and serve as primary point of escalation for executional issues or risks related to deliverables.
• Interact and establish relationships with key clinical trial investigators.
• Contribute to the clinical development strategy for a program or programs providing input on the design and operationalization of the clinical development plan.
• Develop and finalize protocols and (CSR) clinical study reports in collaboration with Clinical Development for scientific and operational accuracy.
• Lead or oversee writing, reviewing, and approval of key clinical project deliverables including clinical study protocols, scope definition documents, investigational product labeling/kitting, pharmacy manuals, informed consent documents, IRB/EC submissions/approvals, site activations, monitoring plans and tools, case report forms, data management plans, safety plans, close-out plans, and inspection readiness plans.
• Provide input to clinical sections of regulatory documents including Investigator Brochures, DSURs, IND annual reports, and others as needed.
• Provide operational expertise to internal functions (CMC, regulatory affairs, nonclinical, medical writing, biometrics) and external teams (CROs, consultants) to ensure that study goals are met.
• Provide reports on program progress, risks, issues, metrics as needed to executive leadership.
• Develop and ensure compliance with company SOPs and guidelines, FDA regulations and current ICH GCP guidelines.
• Hire and manage additional Clinical Operations staff based on program resource needs.
• Act as key resource to provide financial information related to clinical development. Interface with finance group to manage trials costs.
• Travel, as required, to ensure successful trial execution.

Qualifications

• BA/BS degree or higher, in life sciences.
• Minimum 7 years of clinical operations leadership experience and 10 years in the pharmaceutical/biotech industry or relevant clinical research organization.
• Demonstrated experience in leading study execution in a start-up or small biotech environment.
• Strong understanding of regulatory, technical, scientific, operational knowledge related to drug development.
• Experience operating in a clinical-stage or resource-disciplined biotech environment.
• Preferred: Experience in drug development in inflammatory, dermatologic, or pain/CNS-indications.

Competencies

• Strategic thinker with strong execution focus
• Comfortable operating in a lean, fast-paced environment
• Strong project management and organizational skills
• High accountability and ownership mindset
• Excellent written and verbal communication skills
• Ability to influence cross-functionally without direct authority

Compensation

The salary range for this position is $200,000–$260,000, and the position may be eligible for performance-based bonuses and/or equity-linked compensation. Salary ranges are determined by role, level, and location, as well as additional factors such as job-related skills, experience, and relevant education or training. We offer Company-sponsored benefits, including comprehensive health, dental, and vision plans, as well as pet insurance. In addition, we offer a 401(k) plan, ample time-off programs, paid parental leave, life insurance, disability insurance, and an employee referral bonus program.

Evommune is proud to be an equal opportunity employer and will consider all qualified applicants for employment.