TD2 Oncology · 2 days ago
Associate Director, Clinical Operations
TD2 Oncology is the leading oncology CRO focused on developing novel treatments for patients. The Associate Director, Clinical Operations provides strategic and operational leadership across clinical trial execution, ensuring high-quality delivery of oncology clinical studies and managing cross-functional partnerships.
BiotechnologyHealth CareOncologyPharmaceuticalTest and Measurement
Responsibilities
Provide leadership and oversight of project management and clinical operations activities across assigned portfolio, ensuring studies are executed in alignment with contracted services, timelines, quality standards, regulatory requirements, sponsor expectations, and internal SOPs
Manage and develop project management personnel, including providing direction, coaching, performance feedback, career development support, and ensuring appropriate onboarding and training
Partner cross-functionally with Clinical Operations, Data Management, Regulatory Affairs, Safety, Quality, and Business Operations to support effective study planning, execution, and issue resolution
Oversee third-party vendors, CROs, consultants, clinical sites, and other external partners, ensuring contractual scope, timelines, budgets, and performance expectations are met
Monitor trial progress, enrollment, site performance, and operational metrics; support project teams with proactively identify risks, lead mitigation efforts, and support problem-solving as trials progress
Participate in and lead study-level and cross-functional meetings as needed, including interactions with Sponsors to provide operational updates and ensure alignment on trial status and priorities
Ensure compliance with FDA regulations, ICH GCP guidelines, sponsor requirements, and internal policies across all clinical operations activities
Contribute to the development, implementation, and continuous improvement of clinical operations policies, SOPs, systems, and working practices to support scalability and operational excellence
Maintain audit readiness and support internal and external audits, including preparation of documentation, staff readiness, and timely response to findings
Support clinical operations budget development, financial forecasting, and scope management in collaboration with Finance and Business Operations, including identification of out-of-scope activities
Participate in resource planning, study allocation, and capacity forecasting to ensure appropriate staffing across current and future clinical programs
Support recruitment, interviewing, hiring, and onboarding of clinical operations staff, and ensure training documentation and personnel files are accurate and current
Perform other responsibilities as assigned
Travel as necessary to support business needs
Qualification
Required
Oncology clinical trial experience required
Minimum of 8 years of clinical research experience, including leadership or management experience within clinical operations
Experience with line management and development of direct reports
Strong working knowledge of FDA regulations, ICH GCP, and clinical research standards
Experience managing complex, multi-center clinical trials
Broad understanding of clinical trial operations, including study start-up, site management, safety oversight, data management interfaces, and study close-out
Demonstrated ability to lead cross-functional teams and manage external vendors
Strong communication, problem-solving, and decision-making skills
Proficiency in MS Office applications (Word, Excel, PowerPoint); experience with clinical systems
Ability to manage multiple priorities and operate effectively in a fast-paced environment
Preferred
Bachelor's degree in a health science field, or equivalent education and experience
Experience in advanced therapy medicinal products (ATMPs) and radioligand therapy / radiodiagnostics
Company
TD2 Oncology
TD2 Oncology is an oncology-focused Contract Research Organization (CRO) that supports improved and accelerated development of medicines for life-threatening diseases.
Funding
Current Stage
Growth StageTotal Funding
unknown2020-06-04Acquired
Recent News
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