DMPK Project Representative

Description

*Note: exact level depending on experience*

Company Overview: 

Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”.  Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space.  

We are uniquely structured with opportunities for all scientists to contribute to both established programs as well as ongoing early target selection, screens and validation.  We prize scientific excellence, creativity, team players and we are committed to continued innovation.  We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact.  We are growing and there are opportunities for mentorship and career progression.

Vividion was ranked #2 mid-size company on The San Diego Union-Tribune's 2022 and 2023 Top Workplaces list.

Job Summary: 

The DMPK Project Representative will be responsible for representing the Drug Metabolism and Pharmacokinetics (DMPK) functional area on multidisciplinary project teams. This role involves providing scientific and strategic input, leading and innovating in a team environment, and overseeing DMPK studies to support the preclinical and clinical development of the company's portfolio. The successful candidate will design, execute, and manage PK, PK-PD, and drug metabolism studies, integrating ADME, PK, and PK/PD endpoints with discovery biology data to guide optimization strategies. This role also involves preparing data summaries, presenting results, and contributing to regulatory documents to support clinical development and new drug applications.

Requirements

Essential Duties and Responsibilities:

• Represent DMPK functional area on multidisciplinary project teams
• Lead DMPK studies supporting preclinical and clinical development
• Design, execute, and manage PK, PK-PD, and drug metabolism studies
• Collaborate with medicinal chemists to optimize drug candidates
• Integrate ADME, PK, and PK/PD endpoints with discovery biology data
• Lead and manage in-vivo and in-vitro ADME/PK studies
• Conduct PK and PK/PD modeling and predict human PK and efficacious dose projections
• Evaluate and interpret DMPK data and design studies to address project issues
• Prepare data summaries and present results to various stakeholders
• Contribute to nonclinical PK/ADME documents for regulatory submissions
• Prepare regulatory submission documentation and author relevant sections
• Mentor and motivate the in-house DMPK team
• Manage interactions with CROs to ensure quality and timely execution of DMPK studies

What We Would Like to See:

• PhD in Biochemistry, Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences, or related discipline with 2+ years of experience in the industry; or MS with 5+ years of experience; or BS with 10+ years of experience
• Expertise in pharmacokinetics of small and/or large molecules, modelling, drug metabolism, in vitro enzyme kinetics, and LC/MS bioanalytical methodology
• Experience in designing and executing PK and PK/PD studies
• Experience in nonclinical PK/ADME document preparation for regulatory submissions
• Proficiency with Phoenix WinNonlin, Excel, and Prism software
• Familiarity with PBPK modeling is a plus

Core Competencies: 

• Excellent written and verbal technical communication skills
• Ability to lead, guide, and influence teams in decision-making
• Collaborative team behaviors and ability to build and sustain relationships with R&D customers and the wider scientific community
• Ability to work autonomously and collaboratively in a multidisciplinary team setting
• Passion for data-driven analysis and strong business-of-science thinking
• Ability to thrive in a fast-paced, highly matrixed environment
• Strong understanding of DMPK, PK/PD modeling, human PK, and DDI prediction strategies
• Proven track record of leading studies to enable IND filing and contributions to drug discovery
• Ability to apply quantitative skills for model-based drug development and complex issue resolution 
• Proficiency in managing CROs and robust knowledge of relevant regulatory guidance

Further Information: 

In addition to a competitive compensation package with long-term incentives and 401k match, Vividion also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, life, and disability insurance.

Vividion Therapeutics, Inc. is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Privacy Policy:

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