Associate Director, Clinical Operations

Scorpion Therapeutics; United States; On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Financial planning/wuture

Work-life balance

Wellness programs

Life insurance

Disability insurance

Retirement with employer match

Generous PTO

Job summary

Scorpion Therapeutics in San Diego invites an Associate Director, Clinical Operations to drive execution and on-time delivery for Phase 1 clinical pharmacology studies (FIH, SAD/MAD, DDI, QTc, Human ADME, food effect).

You will lead trial activities, coordinate safety/DSC meetings, manage budgets/vendors, mentor staff, and ensure adherence to GCP/SOPs across SMTs.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 8+ years progressive clinical trial experience with leadership roles.
• Experience with US CFR, EU CTD, ICH E6 (R2) GCP.

Responsibilities

• Lead operational execution of Phase 1 Clinical Pharmacology studies.
• Oversee PK/PD sample collection, processing, reconciliation, and shipment.
• Coordinate Safety Review Committee/Dose Escalation Committee meetings (if applicable).
• Manage operational aspects of DDI, food effect, BA/BE, QTc, and organ impairment.
• Partner with Clinical Pharmacology, Bioanalytical Sciences, Clinical Supply, Biometrics, and Nonclinical.

Skills

Leadership

Program management

Communication

Budgeting

MS Office

Smartsheet

IRT/eTMF

Cross-functional teamwork

Education

Bachelor’s degree in Life Sciences

Tools

MS Project

Smartsheet

eTMF

IRT

Job description

Position Summary

Associate Director, Clinical Operations accountable for execution and on-time delivery of milestones for Phase 1 clinical pharmacology clinical trials (FIH, SAD/MAD, DDI, QTc, Human ADME, food effect). Oversees daily trial activities to support internal teams and CROs.

Responsibilities

• Lead operational execution of Phase 1 Clinical Pharmacology studies.
• Oversee PK/PD sample collection, processing, reconciliation, and shipment.
• Coordinate Safety Review Committee/Dose Escalation Committee meetings (if applicable).
• Manage operational aspects of DDI, food effect, BA/BE, QTc, and organ impairment.
• Partner with Clinical Pharmacology, Bioanalytical Sciences, Clinical Supply, Biometrics, and Nonclinical.
• Identify and mitigate operational risks unique to early-phase studies.
• Set standards/goals for Study Management Teams (SMTs); ensure accountability for missed/delayed deliverables.
• Drive SMT deliverables per approved program timelines; provide daily oversight/support to CO representatives.
• Guide SMT members to deliver per clinical operations plan.
• Escalate and resolve issues internally/externally.
• Ensure compliant SMT management per best practices/SOPs (incl. Operational Playbook and BIMO list).
• Provide input into study documents (operational feasibility of sampling schedules, confinement logistics, crossover designs; protocol, ICF templates, study plans/tools, site-facing materials).
• Oversee Phase 1 unit, central labs, and specialty vendors; manage adherence to budgets and forecast changes.
• May provide line management, coaching/mentoring to junior staff and oversight/support to CO representatives.

Education/Experience Requirements

• Bachelor’s in life sciences, nursing, pharmacy, or related; equivalent education/experience may be considered.
• 8+ years progressive clinical trial experience; at least 2 years in a leadership role overseeing clinical trial/program execution.
• Experience with global regulatory/compliance requirements (US CFR, EU CTD, ICH E6 (R2) GCP).
• Significant experience leading Phase 1 Clinical Pharmacology studies and healthy volunteer trials.

Additional Skills/Experience

• Courage, Community Spirit, Patient Focus, Teamwork.
• Ability to adapt to changing project plans; strong oral/written communication and ability to present to senior leadership.
• Analytical problem-solving; strong MS Office and timeline tools (MS Project/Smartsheet); clinical systems experience (e.g., IRT, eTMF).
• Track record managing complex project plans/timelines/budgets/critical paths.
• Highly organized; understands cross-functional clinical study activities.
• Previous line management preferred.
• Travel 10–20%; onsite/face-to-face in San Diego not 100% remote.

Benefits

• Premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement with employer match, and generous paid time off.
• Base pay range: $150,000.00–$195,000.00.