Director / Senior Director, Clinical Pharmacology - ...
Vividion Therapeutics - San Diego, CA
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Note: exact level depending on experienceCompany 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 has been recognized as a Top Workplace by The San Diego Union-Tribune in 2022, 2023, and 2024. Job Summary: We are seeking a highly motivated Clinical Pharmacology leader who is passionate about driving oncology and immunology focused drug development programs at Vividion. This role will represent the clinical pharmacology function on integrated project teams and provide strategic and scientific expertise and input to our clinical programs. The successful candidate will be a scientific leader within clinical pharmacology and be expected to devise early development clinical pharmacology plans, provide expertise in PK/PD, integrate biomarker strategies, and implement model-informed drug development plans into Vividion clinical programs. A solid understanding of regulatory requirements up to and including registration as they pertain to clinical pharmacology is required. This individual will be a leader that is expected to interface across key functional areas including clinical development, biostatistics, clinical biomarkers, drug safety, toxicology, DMPK, CMC, regulatory affairs, and our drug discovery teams while driving cross-functional innovation in our approaches to drug development. Requirements Essential Duties and Responsibilities: Design clinical pharmacology programs to support the development of Vividion oncology and immunology products Represent Clinical Pharmacology on Vividion integrated product teams Lead the design, conduct, interpretation, and reporting of clinical pharmacology studies Provide strategic input and oversight to pharmacometrics projects and champion the use of model-based approaches to facilitate dose optimization, dose selection, and dose modifications based on clinical safety, efficacy, and PK/PD considerations Define clinical drug-drug interaction strategies including the use of PBPK or other modeling approaches to assess DDI potential/risk assessment Author clinical and regulatory documents including clinical protocols, investigator brochures, health authority briefing documents, and relevant sections of regulatory applications. Lead responses to clinical pharmacology inquiries from health authorities. Work collaboratively across functions including clinical development, biostatistics, clinical biomarkers, drug safety, toxicology, DMPK, CMC, regulatory affairs, and our drug discovery teams to drive program support and address project-specific issues Drive external scientific innovation through consortium leadership and publication What We Would Like to See: PhD, PharmD, or MD in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacy or related disciplines with 8+ years of experience in the industry Experience in the management of clinical pharmacology programs across all phases of drug development Experience with the use of modeling and simulation including PK/PD, PBPK, population PK, and exposure-response approaches to address project specific questions including dose optimization and selection and drug-drug interaction assessment Strong track record of regulatory preparation, submissions, and interactions with health authorities Excellent verbal and written communication skills Ability to manage project resources and budgets Strong collaborator with ability to work across functions in a fast-paced, matrixed work environment Core Competencies: Ability to lead, guide, and influence teams in decision-making Excellent written and verbal technical communication skills Collaborative team behaviors and ability to build and sustain relationships across internal scientific functions 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 Proficiency in managing internal and external resources 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: The protection of your personal information is a commitment we take seriously. For information regarding our Privacy Policy (CA candidates) please visit
Created: 2025-03-10