Director, Clinical Operations
Evommune
ABOUT EVOMMUNE
Evommune, Inc. is a private clinical-stage biotechnology creating game-changing science to treat immune-mediated inflammatory diseases by discovering, developing, and delivering therapies that address symptoms and halt progressive disease. Evommune was founded in 2020 by an industry- leading team of R&D experts and biotech company builders, and is headquartered in Palo Alto, California. For more information, visit www.Evommune.com.
This hybrid position is currently expected to be in the office 2 days a week with the option of working remotely 3 days a week. The position reports to the Senior Director, Clinical Operations. for chronic inflammatory diseases. Evommune’s pipeline is focused on advancing new treatment options in underserved patient populations. We target these pathologies at the source, with novel agents that exhibit best-in-class profiles for safety and efficacy, delivering therapeutics for patients that go beyond symptomatic relief.
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.
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 of 7 years prior project management/clinical operations experience and leadership skills (e.g., managing cross functional study teams, CROs, vendors) and 10 years in the pharmaceutical/biotech industry or relevant clinical research organization.
- Proven experience in a startup or small biotech environment, with a demonstrated ability to thrive in cross-functional roles and adapt to dynamic, fast-paced settings.
- Comprehensive working knowledge of ICH/GCP guidelines, CFR, EMA, and HIPAA regulations.
- Strong written and verbal communication skills.
- Excellent organizational and problem-solving skills.
- Entrepreneurial spirit with “can do” attitude, commitment to teamwork, timelines, and initiative.
- Knowledge and experience with managing contracts (vendor and site) and interface with finance group.
- Demonstrates strong leadership presence and the ability to effectively engage and collaborate with stakeholders at all levels, including executive leadership.
Compensation
The salary range for this position is $200,000 - $260,000 the position may be eligible for performance-based bonuses and/or equity-linked compensation. Salary ranges are determined by role, level and location and additional factors, including job-related skills, experience, and relevant education or training. We offer Company-sponsored benefits, which include comprehensive health, dental and vision plans. In addition, we provide 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.
In accordance with the Company’s determination to provide and maintain a safe workplace, the Company expects all employees to be vaccinated against COVID-19 with one of the FDA approved COVID-19 vaccines, unless exempted under applicable law or regulations.