Project and Regulatory Toxicologist (Associate Director to Senior Director)

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 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 has been recognized as a Top Workplace by The San Diego Union-Tribune in 2022, 2023, and 2024.

Job Summary: 

A successful candidate will be expected to use his/her toxicology expertise to guide safety assessment, design and interpret in vitro/in vivo studies to evaluate the safety profiles of our covalently and non-covalently targeted small molecules according to regulatory guidelines. You will work closely with the toxicology function, CROs, and multidisciplinary drug discovery/development teams to progress promising therapeutics to the clinic. 

Essential Duties and responsibilities:

• Represent toxicology function as a subject matter expert on drug discovery and development project teams and provide guidance on strategies for safety characterization, prioritization and advancement of drug candidates
• Directly interface with CROs to place appropriate in vitro and in vivo toxicology studies in a timely manner; manage and oversee the execution of toxicology studies at CROs to ensure high quality data delivery; review and QC study protocols, results, and study reports; summarize toxicology study results and communicate toxicology findings to project teams and senior management accurately and punctually 
• Contribute to the writing of safety study summary, nonclinical overview and other regulatory documents, represent Vividion at regulatory interactions
• Provide strategic input on CTA/IND package design and collaborate broadly with other functions, including chemistry, biology, regulatory, DMPK, CMC, and clinical teams, to support the development of Vividion oncology and immunology portfolio
• May need to identify and implement new strategies on safety assessment to address current and future safety-related challenges, keep abreast of current regulatory requirements by participating in cross-industry consortium or scientific conferences
• Collaborate with early discovery project teams to conduct literature-based target safety assessments and provide guidance on target safety derisking activities

Requirements

Education and Experience requirements:

• Ph.D. in toxicology, pharmacology, or closely related biomedical disciplines 
• Diplomate of American Board of Toxicology is highly desired
• 15+ years of post-graduate experiences which include minimally 10+ years of experiences in a pharmaceutical or biotechnology industry setting, actual job title depends on years and depth of relevant industry experiences
• A broad understanding of various aspects of nonclinical safety assessment and regulatory requirements for drug development, experience representing toxicology function on discovery and development teams is required, expertise in immunology is highly desired 
• Must be able to critically evaluate, interpret and integrate multidisciplinary data to support target and compound safety assessment and mechanistic derisking
• Experiences in the design, conduct, and data interpretation of in vitro and in vivo safety pharmacology, genetic toxicology, immunosafety, and general toxicology studies are required
• Strong track record of regulatory preparation, submissions, and interactions with health authorities is required for the director and senior director levels
• Experiences managing outsourced studies at CROs

Required Key Attributes: 

• Excellent interpersonal skills, with the ability to interact professionally and effectively in a dynamic, multi-disciplinary, and highly collaborative team environment
• Prior leadership and management experiences are required for the director and senior director levels
• Excellent verbal and written communication skills
• Solid problem-solving skills with a strong sense of urgency and scientific curiosity
• Proactive and agile, with the ability to operate in a fast-paced work setting
• Solution- and result-oriented with attention to details 

Pay & Benefits: 

The anticipated base salary for this position ranges from $180,000 to $260,000 depending on relevant skills, competencies, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance. 

EEO & Employment Eligibility:

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:

The protection of your personal information is a commitment we take seriously. For information regarding our Privacy Policy (CA candidates) please visit https://vividion.com/publication/privacy-noticeforcalifornia-candidates/.