Job Description
Job DescriptionDescription:
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:
The Director, Clinical Science will provide the scientific expertise necessary to design and deliver clinical studies and programs. This position works with other development team members, external key opinion leaders, patient advocacy organizations, CROs, clinical sites, and consultants to ensure the appropriate scientific rigor in the clinical program.
Requirements:
Essential Duties and Responsibilities:
- Development of clinical trial designs and protocols in collaboration with external opinion leaders, internal translational science/clinical/medical team
- Provide input to statistical analysis plans and key contributor to all study related documents (informed consent, study manuals, data management plan, safety management plan, protocol deviation plan, etc.)
- Collaborate with clinical operations, data management, biostatistics, and safety on execution of clinical studies to achieve program goals
- Site-facing activities such as training and serving as primary contact for clinical questions
- Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
- Clinical data trend identification: provide trends and escalate questions to Medical Monitor
- Develop clinical narrative plan; review clinical narratives
- Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
- Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Collaborate and serve as primary liaison between external partners for scientific advice
Experience and education requirements:
- Advanced degree (PhD, MD, PharmD) in a scientific discipline preferred with solid knowledge and experience of overall and early clinical development
- 8+ years of experience in clinical science, clinical research, or equivalent
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
Pay & Benefits:
The anticipated base salary for this position ranges from $220,000 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/.