Note: The job is a remote job and is open to candidates in USA. Telix Pharmaceuticals is seeking an Associate Director, Clinical Operations to lead operational planning and execution of clinical studies, ensuring they meet timelines, budgets, and quality standards. The role oversees clinical trial teams, CROs and vendors, study plans and budgets, and supports staff development and regulatory compliance.
Responsibilities
- Oversees the management of clinical trials from their inception to completion, expertly guiding both internal and external multidisciplinary teams
- Leads and manages integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge
- Manages performance, development and growth of junior staff to support and guide them to improved efficiency and effectiveness at prioritization and problem solving, highly experienced as a line manager
- Drives the review and completion of all study-related plans and systems according to timelines and standards
- Effectively communicate and interact with study PIs, as required
- Manage and oversee aspects of CRO/vendor identification/procurement, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor, in collaboration with CPMs
- Participate in Case Report Form design, user acceptance testing in partnership with data management
- Lead the development of contingency/risk management plans for projects and assist Sr Director/Director of Clinical Operations in the preparation and execution of sound development strategies
- Provide support to clinical project managers within and/or across programs
- Assist in preparing budgets, study timelines, and forecasts in collaboration with Sr. CPM/CPM for Sr Director/Director of Clinical Operations approval
- Maintain rigorous compliance with study plans, monitoring clinical studies through direct communication with CROs and investigator sites
- Strategically plan and coordinate with cross-functional teams for optimal execution of clinical trials
- Identify potential study issues, formulating proactive contingency plans
- Mentor team members and manage direct reports, fostering professional growth
- Participates in the development and review of the protocol and informed consent to provides an operational feasibility perspective and confirm clarity of procedures
- Contributes to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes for assigned studies within the department
- Oversees study budget, investigator and vendor contracts, budgets, and payments, reviews accruals on a regular basis
- Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready
- Supports audit/inspection activities as needed
- Maintain a state of inspection readiness for clinical development inclusive of TMF
- Partner with regulatory and medical to ensure safety management and monitoring processes are implemented
- Initiate clinical change control process for studies, as appropriate
- Embrace an organizational culture that fosters diversity, equity, and inclusion
Skills
- Bachelor's degree in health science or related field is required
- 6+ years of clinical research experience gained with a Biotechnology or Pharmaceutical Company working on all stages (Phase 1-4) multinational clinical studies
- 4+ years clinical project management experience with global clinical studies
- Demonstrated knowledge of ICH guidelines, GCP, and global regulatory requirements for clinical trials
- Must understand clinical development processes and the interdependencies of various tasks that require coordination among asset team, functional/regional team members and third parties
- Proven ability and experience with coaching others
- Ability to embrace the diversity of thought to model innovative behaviors (e.g., reaching across boundaries, inspire and empower others and lead decisively in the midst of ambiguity)
- Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability
- Excellent communication (written and verbal) and presentation skills along with leadership qualities
- Advanced skills in Microsoft Office Suite and a keen eye for detail
- Proven ability to collaborate effectively both internally and externally
- Experience in facilitating project team meetings and ensuring stakeholder alignment
- Advance skills in Veeva Vault, and various EDCs (i.e., Medidata RAVE, Viedoc etc)
- An advanced degree in a scientific discipline is preferred
- Experience in oncology, nuclear medicine and/or radiopharmaceuticals trials preferred
- Proven experience in effectively leading teams and managing direct reports preferred
Benefits
- Annual performance-based bonuses
- An equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote work arrangements
Company Overview
Company H1B Sponsorship