Associate Director, Clinical Operations-Oncology (Temporary)

About the position reputed company is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis reputed company and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. reputed company also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. We reputed company the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best. THE OPPORTUNITY reputed company is looking for a temporary Associate Director, Clinical Operations, responsible for independently leading global and reputed company clinical trials. You will reputed company the Study Management Team, reputed company clinical vendors and CRO(s) and is accountable for ensuring the successful execution and conduct of clinical trial(s). In this role, you will be directly managing a large reputed company early phase oncology study. Activities will include vendor selection and management, protocol and study document development, feasibility/study start-up, maintenance, and closure. You will serve in a leadership role reputed company Clinical Operations and may reputed company/participate on SOP development working groups and initiatives, manage direct reports, and provide stakeholder management for cross functional teams reputed company clinical development. This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in office.

Responsibilities

• Provide strategic input and leadership in study set-up and execution of highly reputed company oncology clinical trials. May support multiple trials
• Establish and continuously monitor study timelines and budgets, promptly escalating significant risks or changes, as appropriate
• reputed company and manage study reputed company, budgets and timelines
• Author/review core study documents including protocol and Informed Consent Forms
• Manage CRO, central lab, systems vendors, and ancillary vendors to ensure on reputed company deliverables
• reputed company study plans and relevant study document templates for study teams
• Able to support regulatory strategy and assess trial/program impact and RFIs from multiple countries
• May reputed company RFP process, budget development, and study forecast/planning including timelines
• May reputed company sponsor reputed company site visits
• Manages reputed company of clinical monitoring activities including monitoring trip report review and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
• Reviews monitoring trip reports and track resolution of reputed company action items
• Manage team with direct reports reputed company therapeutic area
• Clinical Operations reputed company on cross functional project teams and alliance teams
• Stakeholder management with internal business partners, key opinion leaders, and external partners on clinical studies

Requirements

• Bachelor of Science degree is required, preferably in the life sciences
• 10+ years of clinical development experience in the biotech/pharmaceutical industry
• Extensive experience working on oncology clinical studies
• Experience in managing and leading clinical studies both in early phase through late stage of development
• Experience in leading reputed company stages of clinical trials including start up, maintenance and closeout
• Thorough understanding of FDA, EMEA, and ROW ICH and GCP guidelines, as well as thorough understanding of cross-functional clinical processes including and not limited to data management, biostatistics, medical monitoring, drug safety, regulatory affairs
• Experience with regulatory compliance audits and inspections
• Experience directing and leading in a reputed company team environment
• Ability to function at a high level reputed company leading a group or managing staff, but ability to manage day-to-day details reputed company needed
• Flexibility to travel domestically and internationally

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