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.