Senior Director of Clinical Operations

Arvinas • New Haven, CT

3d • Hybrid

About The Position

The Senior Director, Clinical Operations provides strategic and operational leadership for assigned oncology clinical programs, with a strong focus on first-in-human (FIH) and dose-escalation studies. This role is accountable for end-to-end execution, ensuring studies are delivered with high quality, regulatory compliance, and speed. The position requires demonstrated leadership in CRO and vendor management, cross-functional decision-making, and risk mitigation in complex global trials. This role may oversee one or more studies or programs and serves as a key operational partner to Clinical Development, Regulatory, Biometrics, Quality, and Sourcing.
This position reports to senior Clinical Operations leadership and may be remote, hybrid, or based in New Haven, CT.

Requirements

• 15+ years of clinical operations experience in drug development.
• Demonstrated leadership in oncology clinical trials, including FIH and dose-escalation studies.
• Proven experience leading global studies and managing CROs and vendors.
• Experience in fast-paced early development environments.
• Strong leadership, judgment, and decision-making skills.
• Ability to balance speed and accountability.
• Excellent stakeholder management and communication skills.
• Deep understanding of clinical trial operations and regulatory requirements.
• Bachelor’s degree in a clinical or science-based field required; advanced degree preferred.

Responsibilities

• Provide operational leadership and accountability for oncology clinical trials, including FIH and dose-escalation studies.
• Translate asset and governance decisions into executable operational plans, timelines, and resourcing strategies.
• Lead and influence cross-functional teams to drive timely decision-making.
• Lead operational planning and execution of Clinical Pharmacology studies (e.g., FIH, SAD/MAD, food effect, DDI, QTc, bioavailability studies).
• Develop and maintain the study operational plan, timelines, and cross-functional deliverables in collaboration with Clinical Pharmacology, Data Management, Biostats, Safety, and Regulatory.
• Coordinate study start-up, site readiness, and operational oversight, including monitoring enrollment, dosing milestones, and data delivery timelines.
• Lead cross-functional study team meetings, track risks and issues, and ensure timely resolution to maintain study timelines.
• Ensure Trial Master File (TMF) completeness and inspection readiness throughout the study lifecycle.
• Provide regular study status updates to program leadership, highlighting progress, risks, and mitigation strategies.
• Lead the end-to-end operational execution of assigned studies from startup through close-out.
• Own study timelines, deliverables, and operational KPIs; proactively identify and mitigate risks.
• Oversee FIH dose-escalation execution, including cohort management and safety review coordination.
• Drive feasibility, country and site strategy, and global startup execution.
• Ensure investigator meetings, SIVs, and training strategies are aligned with study complexity.
• Provide strong oversight and governance of CROs and vendors.
• Partner with Sourcing and Finance on CRO selection, contracting, change orders, and budget oversight.
• Ensure CRO execution aligns with sponsor expectations for speed, accountability, and quality.
• Lead regular vendor governance and performance reviews.
• Ensure studies are conducted in accordance with ICH/GCP, FDA, EMA, and global regulations.
• Partner with QA to ensure readiness inspection.
• Oversee monitoring strategies, data review cadence, and clinical data quality oversight.
• Act as a key operational partner to Clinical Development, Regulatory Affairs, Biometrics, Data Management, and QA.
• Provide clear communication on progress, risks, and decisions.

Benefits

• Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director