Associate Director, Clinical Operations

How you’ll make an impact:
- Contribute to planning, implementation, and execution of global clinical trials.
- Plan, execute, and lead study-specific meetings (e.g., internal core team, investigator meetings).
- Provide input for design of Informed Consent Forms, eCRFs, monitoring conventions, and edit checks.
- Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites, and other contractors.
- Manage study timelines and metrics; maintain accurate and complete trial documentation.
- Lead site feasibility/selection qualification, initiation, and oversight of outsourced monitoring.
- Review monitoring reports to ensure quality and resolve site-related issues.
- Ensure timely enrollment and data collection; collaborate with data management for data integrity and database lock.
- Track/review protocol deviations and assess impact on study data.
- Coordinate bioanalytical sampling plan incorporation with translational medicine.
- Partner with Operational Excellence/Site Engagement Leads to drive site engagement and recruitment.
- Build RFPs and support clinical vendor selection (Clinical Outsourcing counterpart).
- Oversee Sponsor Oversight (KPIs, risks, KRIs, data review findings) and ensure mitigations.
- Contribute to process improvements; proactively identify and resolve clinical project issues.
- Travel up to 25%.

Skills and experience you’ll bring:
- BS degree; 8+ years clinical operations experience in biotech/pharma; 5 years leading global trials.
- Inspection readiness experience preferred.
- Experience with large, global, complex Phase 2b/3 or late-stage trials; Respiratory or Immunology highly preferred.
- Knowledge of CFR, ICH GCP, HIPAA, GDPR, and protection of human research subjects.
- Strong project management; leadership/problem-solving/communication; cross-functional collaboration.

Compensation (anticipated):
- Base salary $160,000–$240,000; annual bonus, equity, and comprehensive benefits.