Associate Clinical Project Manager – Sponsor Dedicated
IQVIA
Google Cloud Platform
VP, Clinical Operations
Kenai Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $270,000 - $305,000 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Develop and execute clinical operations strategies to support company objectives and ensure alignment with the broader business goals.
- Collaborate with senior leadership, including the CMO, to shape and execute the clinical development strategy, ensuring it meets regulatory, scientific, and commercial needs.
- Lead the planning, design, and execution of clinical trials, ensuring adherence to timelines, budgets, regulatory standards (GCP/ICH), and quality expectations.
- Oversee the creation and execution of critical clinical documents, including study protocols, clinical study reports, investigator brochures, and safety monitoring plans.
- Develop resourcing strategies to support clinical program needs, ensuring adequate and efficient allocation of resources for both internal and outsourced activities.
- Identify, select, and manage external vendors, CROs, and other partners, ensuring high performance and adherence to project goals and timelines.
- Lead and collaborate with other functional areas, including Regulatory Affairs, Medical Affairs, Biometrics, and Research, to ensure integration of project goals and efficient execution of clinical programs.
- Serve as a key representative of Clinical Operations in interactions with external stakeholders, including KOLs, patient advocacy groups, regulatory agencies, and vendors.
- Ensure the patient voice is integrated into the planning, design, and execution of clinical trials.
- Oversee the clinical trial budgets, resource allocation, and financial forecasting, ensuring projects are delivered on time and within budget.
- Provide regular updates to executive management on the status of ongoing clinical programs and trials.
- Ensure that all clinical trials comply with applicable regulatory guidelines, including FDA, EMA, and ICH standards.
- Collaborate with the pharmacovigilance team to monitor and evaluate the safety profile of drugs under investigation, ensuring continuous safety monitoring and compliance.
- Lead, mentor, and develop a high-performing Clinical Operations team, providing coaching, training, and career development opportunities.
- Foster a culture of collaboration, quality, and excellence within Clinical Operations and across the organization.
Requirements
- REQUIRED: Experience in cell and gene therapy, deployed for interventional studies in the nervous system
- Minimum 15 years of experience in clinical operations, with at least 10 years in leadership roles within the pharmaceutical or biotechnology industry.
- A bachelor’s degree in life sciences (or related field) is required; an advanced degree (e.g., MBA, PhD) is preferred.
- Proven experience in managing both early-phase and late-phase clinical trials, including vendor management and outsourcing.
- Strong understanding of regulatory requirements (FDA, EMA, ICH), GCP, and clinical trial design.
- Demonstrated success in building and leading cross-functional teams, mentoring staff, and driving organizational change.
- Excellent strategic thinking and problem-solving skills, with the ability to navigate complex issues and make data-driven decisions.
- Exceptional written and verbal communication skills, with the ability to present complex clinical data and trial parameters to both internal and external stakeholders.
- Proficient in Microsoft Office Suite; experience with clinical trial management systems (CTMS) and other clinical development tools is a plus.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical operationsclinical trial designvendor managementoutsourcingregulatory requirementsGCPclinical trial management systemsdata-driven decision makingfinancial forecastingsafety monitoring
Soft skills
strategic thinkingproblem-solvingmentoringleadershipcollaborationcommunicationorganizational changeteam buildingcoachingpresentation skills
