AD, Clinical Study Management
Associate Director, Clinical Study Management
Company: Innovation‑driven biotech
Work style: Hybrid
Function: Clinical Operations / Study Management
Employment type: Full‑time
Company Snapshot
We're a science‑first biopharmaceutical organization that brings together chemical biology, advanced instrumentation, and computational methods to unlock difficult drug targets. Our live‑cell, high‑resolution discovery platform enables direct observation of protein behavior in native cellular contexts, opening new paths to medicines for serious diseases.
Role Summary
The Associate Director, Clinical Study Management will lead end‑to‑end execution of clinical trials-primarily in oncology, with flexibility to support additional therapeutic areas as needed. You'll provide day‑to‑day leadership to cross‑functional study teams, ensure delivery against time, cost, and quality commitments, and embed inspection readiness from start‑up through close‑out. The role reports within Clinical Operations and partners closely with Clinical Development and adjacent functions.
What You'll Lead
- Own study delivery against clinical development objectives-timelines, enrollment, budget, quality, and data integrity.
- Operate with limited oversight, coordinating across Study Management, Clinical Development, Biometrics, Safety, CMC, and Regulatory.
- Shape operational strategy: contribute to study design inputs, operational risk assessment, and program‑level trade‑offs.
- Ensure compliance with protocol, ICH‑GCP, FDA/EMA/PMDA and other applicable regulations, plus internal quality standards.
- Proactively manage risk-identify, assess, and implement mitigations to protect patient safety and data quality.
- Drive inspection‑readiness throughout the trial lifecycle; instill right‑first‑time documentation and auditability.
- Build and maintain integrated timelines, critical path views, and recovery plans; track and escalate variances.
- Direct vendor management (non‑CRO vendors and functional suppliers): scope, contracts, performance, and deliverables.
- Partner with Finance and Legal to align budgets, SOWs, and milestone payments; ensure fiscal stewardship.
- Provide clear, routine stakeholder updates to Clinical Ops leadership, Program/Portfolio Management, and Clinical Development.
- Oversee document quality and filing across TMF/eTMF (e.g., Veeva), regulatory, safety, and finance systems.
- Hire, coach, and develop Clinical Study Management talent; set expectations, provide feedback, and enable career growth.
- Contribute to process improvement and systems initiatives that elevate operational excellence across the portfolio.
About You
You're a collaborative, solutions‑oriented clinical operations leader who thrives in global trial execution and cares deeply about patient impact-especially in oncology. You balance strategic thinking with hands‑on delivery, and you elevate teams through clarity, accountability, and a growth mindset.
Qualifications
- Bachelor's degree with 10+ years relevant clinical operations experience (or 8+ years with an advanced degree).
- Demonstrated success leading large, multi‑country studies, ideally oncology; additional TA flexibility is a plus.
- Deep working knowledge of ICH‑GCP and major health authority expectations (e.g., FDA, EMA, PMDA).
- Track record of delivering on time and on budget while sustaining high quality and patient safety standards.
- Strong leadership and communication skills; proven ability to guide cross‑functional teams in a matrix environment.
- Experience managing budgets, headcount, processes/controls, vendor performance, and productivity/quality metrics.
- High accountability and urgency; able to prioritize and make informed trade‑offs with incomplete information.
- Independent operator with a continuous‑improvement mindset.
Benefits Snapshot
- Competitive bonus and equity programs
- 401(k) with company match
- Comprehensive medical, dental, and vision coverage with high employer contribution
- Mental health & wellness resources
- Company‑wide summer and winter breaks
- Robust PTO and holidays
- Company‑paid life/AD&D, with optional supplemental coverage
- Enhanced parental leave
- Subsidized on‑site lunch on in‑office days
Compensation
Expected base salary range: $180,000-$198,000, commensurate with skills, scope, and market conditions.