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Location

Palo Alto, CA | United States

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Job description

ABOUT EVOMMUNE

Evommune, Inc. is a private clinical-stage biotechnology inventing new ways to treat inflammatory diseases. The company is evolving immunology through its unique and dynamic human tissue-based approach to 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

This position is currently expected to be in the office 2 days a week with the option of working remotely 3 days a week. At this time, most Evommune employees attend the office on Tuesdays and Wednesdays (at a minimum).

The position reports to the Executive VP of Operations. This is a unique opportunity to join an innovative biotech start-up to develop novel therapeutics to meet currently unmet medical needs.

THE POSITION

Director/ Senior Director, Regulatory Affairs

Evommune is seeking a highly motivated, dynamic Director/Senior Director of Regulatory Affairs to lead, develop, and implement regulatory strategies to support the development of investigational products. This role will collaborate with project teams and external advisors and lead submission activities for US INDs and ex-US CTAs, as applicable thorough coordination and collaboration with document authors as well as vendors that manage electronic submissions. The Director/Senior Director will support to on-going clinical activities and develop and maintain regulatory archives.

Responsibilities

• Participate on project teams and oversee development and implementation of regulatory strategies for timely drug development of investigational products and pipeline candidates through all phases of development.
• Understand, interpret, and communicate US and international regulatory requirements to allow strategies to be developed and quality documents to be prepared for regulatory submissions.
• Collect and evaluate data, information, and input from multiple sources, and functions to create a cohesive content strategy for regulatory submissions. Plan, write, edit, review, coordinate, and complete the regulatory documents supporting product development.
• Interact with project teams and external experts as needed to solicit guidance on regulatory matters. Interact with representatives of US and international regulatory agencies and key company management or vendors to facilitate timely agency feedback during development and ultimately acceptance/approval of major submissions (INDs, CTAs, NDAs, BLAs, MAAs, amendments and supplements).
• Build partnerships with key senior stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise. Interfacing with external consultants as needed.
• Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.
• Maintain INDs (and CTAs as applicable) to support ongoing clinical trial activities.
• Interface with publishing vendors to ensure compliant electronic submissions to FDA, and ex-US regulatory agencies as needed.
• Maintain use of templates and guidelines for documentation to be used in regulatory submissions.
• Oversee development and maintenance of regulatory archives.
• Support the development of relevant policies, processes, and SOPs.
• Provide regulatory due diligence assessments of new business opportunities as required.

Qualifications

• BS/MS/PhD (or equivalent) in a scientific discipline and at least 5 years of Regulatory experience, or equivalent based on training and experience.
• Experience preparing, submitting, and maintaining INDs/CTAs and other regulatory submissions throughout the multiple phases of drug development.
• Experience in developing and managing complex regulatory strategies and submissions.
• Experience with US and international regulatory agency interactions.
• Knowledgeable regarding US laws and regulations as well as FDA and ICH guidelines.
• Excellent written and interpersonal communication skills.
• Proven ability to influence and lead
• Prior experience managing vendors of electronic submissions and familiarity with regulatory operations.
• Detail-oriented with ability and desire to work in a fast-paced, team-oriented, hands-on, small company environment.

Compensation

The salary range for this position is $200,000 to $300,000 and the position may be eligible for performance-based bonuses and/or equity-linked compensation. Salary ranges are determined by role, level and location 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 requires all employees to be Fully Vaccinated against COVID-19 with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as guided by your licensed healthcare provider and/or any applicable laws/regulations.

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