Associate Director, Clinical Operations

Scorpion Therapeutics; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director, Clinical Operations to lead global, complex oncology trials from early to late stages. You will manage the Study Management Team, set up studies, and drive strategic execution with cross-functional partners in a fast-paced biotech environment.

You are expected to oversee timelines, budgets, contracts, and vendor relationships, while ensuring GCP and regulatory compliance. Travel domestically and internationally as needed.

Qualifications

• BS degree required (life sciences preferred).
• 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 such as data management, biostatistics, medical monitoring, drug safety, regulatory affairs.

Responsibilities

• Lead global, complex clinical trials and provide study leadership and execution accountability.
• Lead the Study Management Team on a large complex early-phase oncology study.
• Provide strategic input and lead study setup and execution of highly complex oncology trials.
• Establish and monitor study timelines and budgets; escalate significant risks/changes.
• Develop and manage study contracts, budgets, and timelines.
• Author/review core study documents including protocols and Informed Consent Forms.
• Manage CROs and vendors to ensure on-target deliverables.
• Develop study plans and templates for study teams.
• Support regulatory strategy; assess trial 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 monitoring activities to ensure GCP/regulatory compliance; track site performance.

Education

BS degree, life sciences

Job description

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