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
Associate Director, Clinical Operations in san francisco at Unknown Company
This position is listed as contract and onsite.