Director, Clinical Operations — Hybrid Biotech Leader

Amplitude Venture Capital; 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

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.