Associate Director / Director, Clinical Pharmacology – Oncology/Immunology

Vividion Therapeutics. Inc.; San Diego (CA); On-site; USD 190,000 - 240,000; Full time

Job summary

Vividion Therapeutics, a leader in biotechnology, is seeking a Clinical Pharmacology leader to drive oncology and immunology drug development. This role encompasses program design, regulatory interactions, and collaboration across functions, requiring extensive experience and strong leadership within clinical pharmacology.

Benefits

Relocation assistance

Target bonus eligibility

401k retirement savings plan with company match

Comprehensive benefits package

Qualifications

• 8+ years of experience in the industry.
• Experience with PK/PD modeling and simulation.
• Strong track record of regulatory interactions.

Responsibilities

• Design clinical pharmacology programs for Vividion products.
• Lead the conduct of clinical pharmacology studies.
• Author clinical and regulatory documents.

Skills

Leadership

Communication

Collaboration

Data-driven analysis

Education

PhD, PharmD, or MD in Clinical Pharmacology

Job description

Description

*Note: this is an in-person position. Relocation assistance provided if needed. The exact level will depend 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 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

Pay & Benefits:

The anticipated base salary for this position ranges from $190,000 to $240,000 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. All applicants will receive consideration for employment without regard to disability or veteran 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/privacy-notice/.