Vice President, Clinical Science and Operations
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Vice President, Clinical Science and OperationsRegular Full-Time VP/Officer United States
2 days ago Requisition
Salary Range: $ To $ Annually
Position SummaryThe Vice President of Clinical Science and Operations is a senior leadership role responsible for the oversight, execution, and strategic direction of clinical development programs across all phases, including post-marketing activities. The Vice President ensures milestones are achieved and ensures that Clinical Science and Clinical Operations strategies align with corporate goals, regulatory requirements, and industry best practices to advance the Company’s product pipeline, support commercialization efforts, and optimize post-marketing data and evidence generation.
The Vice President is accountable for delivering high-quality clinical programs across all phases (I–IV), including post-marketing studies, ensuring alignment with regulatory, commercial, and organizational goals. The Vice President plays a critical role in guiding cross-functional teams, optimizing trial design and execution, and mentoring talent within the clinical organization. The Vice President is a critical member of the early- and late-stage Product Development Team (PDT) and Research and Development Leadership Team (RDLT) and works to drive proactive identification and resolution of clinical project issues.
This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Vice President will report to the Executive Vice President, R&D and Chief Medical Officer.
Primary Responsibilities- Lead and integrate the scientific and operational strategies for clinical development programs, spanning early development and Phases I–IV and post-marketing studies, to support regulatory submissions, commercialization, and lifecycle management
- Collaborate with executive leadership and cross-functional partners to align clinical development plans with corporate objectives and commercial priorities as part of RDLT
- Provide guidance to the Chief Medical Officer, Head of R&D, and senior leaders on clinical trial design, data interpretation, risk management, and scientific rigor
- Direct the development and oversight of clinical protocols, study designs, and scientific plans as a member of the early- and late-stage PDTs
- Oversee planning, initiation, and execution of clinical trials, ensuring delivery on time and with high quality
- Oversee feasibility assessments and select trial geographies to ensure strategic fit and operational efficiency
- Drive site/investigator selection, engagement, and relationship management to optimize enrollment and site performance
- Oversee contract research organization (CRO) and vendor management, ensuring compliance, performance, and issue resolution
- Manage clinical program budgets, track spending, and align resources with portfolio priorities
- Oversee and support post-marketing trials and real-world evidence generation initiatives on safety, efficacy, and market value
- Support collection, analysis, and reporting of clinical and post-marketing data to ensure accurate safety monitoring and continuous product profile optimization
- Engage and collaborate with key opinion leaders, healthcare professionals, vendors, and CROs to enhance study execution, scientific validity, and product adoption
- Lead, mentor, and develop high-performing Clinical Science and Clinical Operations teams, fostering a culture of innovation, accountability, and continuous professional growth
- Ensure Clinical Science and Clinical Operations deliverables meet timelines, budget, quality, and compliance standards
- Ensure clinical trials comply with ICH-GCP, global regulatory guidelines, and internal SOPs
- Drive proactive identification and resolution of clinical and operational issues and lead process improvement initiatives
- Represent the Clinical Science and Clinical Operations departments in internal leadership forums, external presentations, and cross-functional governance bodies
- Collaborate on the preparation of regulatory…
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