Director, DMPK - Palo Alto, CA, United States - Evommune, Inc.

Description

ABOUT EVOMMUNE

Evommune, Inc., a Palo Alto based biotech company, is creating game-changing science to treat immune-mediated inflammatory diseases by discovering, developing, and delivering therapies that address symptoms and halt progressive disease. 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. Currently, most Evommune employees attend the office on Tuesdays and Wednesdays (at a minimum). The position reports to the Executive Director, Non-Clinical Development. This is a unique opportunity to join an innovative biotech start-up to develop novel therapeutics to meet currently unmet medical needs.

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, DMPK

Evommune is seeking a highly motivated, dynamic Director, DMPK who wants to be part of an exciting startup company and enjoys working with fun, passionate, and talented coworkers. The Director of DMPK provides technical and scientific leadership in establishing ADME/PK/PK-PD strategies for discovery and development program with small molecules. As a subject matter expert, they will collaborate closely with multiple R&D functional areas to support DMPK needs, enabling decision making for advancement of projects, including first-in-human dose predictions. The candidate will serve as DMPK program lead and is responsible for study design, execution, data interpretation and data reporting. Prior experience with preparation and review of regulatory filing documents to support IND, IB, FIH, CTA and NDA/BLA filings is essential.

Responsibilities

• Develop and implement DMPK and PK-PD strategies to support timely selection and development of small molecules.
• Participate on discovery and development project teams while providing scientific/functional leadership.
• Build and maintain strong collaborative partnerships with medicinal chemistry, research, toxicology, technical operations/CMC, and clinical groups.
• Design, oversee, and analyze DMPK studies while timely communicating study results to project teams and senior management.
• Manage contract research organizations (CROs)/vendors and consultants.
• Be responsible for or author PK sections of regulatory submissions and respond to questions from regulatory agencies.
• Address additional responsibilities related to DMPK as they arise.

Qualifications

• PhD in PK, drug metabolism, or a related discipline with at least 10 years of relevant industry experience or equivalent experience based on training and experience.
• Experience with:
  • Clinical candidate selection and development of small molecules.
  • Design/conduct of experiments to understand drug disposition profiles and PK-PD relationships for program advancements and translation from preclinical to clinical.
  • Hand-on analysis of PK and PK-PD data using applicable software.
  • First-in-human dose projections.
  • Regulatory document preparation and interactions with US and international regulatory agencies.
  • Managing CROs/vendors and consultants.
• Ability to oversee bioanalytical studies and support clinical pharmacology as needed.
• Understanding of regulatory guidelines to support small molecule drug development.
• Excellent written and interpersonal communications.
• Proven problem solving and analytical abilities.
• 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 $190,000 to $250,000 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.