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Associate Director, Clinical Operations

Scorpion Therapeutics

Associate Director, Clinical Operations Responsibilities / What You'll Do Independently lead global, complex clinical trials; provide study leadership and accountable execution/conduct of trials Lead the Study Management Team; directly manage a large complex early-phase oncology study Provide strategic input and lead study set-up and execution of highly complex oncology clinical trials (may support multiple trials) Establish and continuously monitor study timelines and budgets; escalated significant risks/changes Develop and manage study contracts, 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-target deliverables Develop study plans and relevant study document templates for study teams Support regulatory strategy; assess trial/program impact and RFIs from multiple countries May lead RFP process, budget development, and study forecast/planning including timelines May perform sponsor oversight site visits Oversee clinical monitoring activities (monitoring trip report review, site management) to ensure GCP and applicable regulatory compliance; track site performance metrics Review monitoring trip reports and track resolution of action items Manage a team with direct reports within the therapeutic area Serve as Clinical Operations lead on cross-functional project and alliance teams Qualifications / Who You Are BS degree required (preferably life sciences) 10+ years clinical development experience in biotech/pharma Extensive oncology clinical study experience Experience managing and leading clinical studies from early to late stage Experience across all trial stages (start-up, maintenance, closeout) Thorough understanding of FDA/EMEA/ROW ICH and GCP; cross-functional clinical processes (data management, biostatistics, medical monitoring, drug safety, regulatory affairs) Experience with regulatory compliance audits/inspections Experience directing/leading in complex teams Ability to manage high-level leadership and day-to-day details Flexibility to travel domestically and internationally Location San Francisco headquarters; at least 3 days/week in office #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 2 days ago
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