Director, Clinical Operations

Evommune, Inc.•Palo Alto, CA

3d•$200,000 - $260,000

About The Position

Evommune is seeking a strategic, dynamic Director of Clinical Operations to oversee tactical implementation of clinical trials, including timelines, resources, and budgets. The Director is a member of the clinical team and collaborates across functions to support the strategy and execution of development programs. The role may directly manage team members and/or oversee consultants and external partners in a matrixed structure. The position leads clinical trial execution, vendor oversight, risk mitigation, and the development and review of clinical and regulatory deliverables. It provides operational expertise to internal and external teams, reports program progress and risks to executive leadership, and helps ensure compliance with company procedures, FDA regulations, and current ICH GCP guidelines. The Director also supports trial financial management, hires and manages Clinical Operations staff as needed, and travels as required for successful trial execution.

Requirements

BA/BS degree or higher in life sciences.
At least 7 years of clinical operations leadership experience.
At least 10 years of experience in the pharmaceutical/biotech industry or a relevant clinical research organization.
Demonstrated experience leading study execution in a start-up or small biotech environment.
Strong regulatory, technical, scientific, and operational knowledge related to drug development.
Experience operating in a clinical-stage or resource-disciplined biotech environment.
Strong project management and organizational skills.
High accountability and an ownership mindset.
Excellent written and verbal communication skills.
Ability to influence cross-functionally without direct authority.

Nice To Haves

Experience in drug development in inflammatory, dermatologic, or pain/CNS indications.
Strategic thinking with a strong execution focus.
Comfort operating in a lean, fast-paced environment.

Responsibilities

Lead and oversee execution of one or more clinical trials according to program timelines and budgets, proactively mitigating risks related to trial conduct, deliverables, vendor performance, and quality.
Select and oversee CROs and ancillary vendors, serving as the primary escalation point for execution issues or deliverable risks.
Interact with and establish relationships with clinical trial investigators.
Contribute to clinical development strategy, including input on development plan design and operationalization.
Develop and finalize protocols and clinical study reports in collaboration with Clinical Development.
Lead or oversee writing, review, and approval of clinical project deliverables, including protocols, scope documents, investigational product labeling and kitting, pharmacy manuals, informed consent documents, IRB/EC submissions and 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, and IND annual reports.
Provide operational expertise to internal functions and external teams to help ensure study goals are met.
Report program progress, risks, issues, and metrics to executive leadership as needed.
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.
Provide financial information related to clinical development and work with Finance to manage trial costs.
Travel as required to ensure successful trial execution.

Benefits

Company-sponsored comprehensive health plans
Dental plans
Vision plans
Pet insurance
401(k) plan
Ample time-off programs
Paid parental leave
Life insurance
Disability insurance
Employee referral bonus program
The position may be eligible for performance-based bonuses and/or equity-linked compensation.