Senior Director of Clinical Operations

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.

In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and “undruggable” targets, the company has three investigational clinical-stage programs currently enrolling:  ARV-102 for the treatment of patients with neurodegenerative disorders,ARV-393 for the treatment of patients with relapsed/refractory non-Hodgkin Lymphoma and potentially other lymphomas, and ARV-806, a KRAS G12D PROTAC for the treatment patients with solid tumors with KRAS G12D mutations.  

On August 8^th 2025, the U.S. Food and Drug Administration (FDA)  accepted the New Drug Application (NDA) for vepdegestrant- an investigational, orally bioavailable PROTAC estrogen receptor degrader- for its use as a monotherapy in the treatment of adults with estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the out-licensing and commercialization of vepdegestrant.

In April 2024, Arvinas entered into a transaction with Novartis, including a global license agreement for the development and commercialization of the clinical stage PROTAC androgen receptor protein degrader ARV-766 for the treatment of prostate cancer. The transaction closed in May 2024.

#TeamArvinas is made up of passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and mission – to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC protein degradation platform. We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. But don’t just take our word for it – learn more about life at Arvinas and what employees have to say.

For more information, please visit www.arvinas.com. 

Position Summary

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.

Principal Responsibilities

Leadership Expectations

This role is expected to operate as a leader, anticipating issues, driving alignment, and holding teams and vendors accountable for delivery.

Strategic and Leadership 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.

Study Execution and Oversight

• 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.

CRO and Vendor Management

• 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.

Compliance and Quality

• 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.

Cross-Functional Collaboration

• Act as a key operational partner to Clinical Development, Regulatory Affairs, Biometrics, Data Management, and QA.
• Provide clear communication on progress, risks, and decisions.

Qualifications

Experience

• 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.

Skills and Competencies

• 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.

Education

• Bachelor’s degree in a clinical or science-based field required; advanced degree preferred.

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. To learn more about Arvinas, please visit www.arvinas.com

Arvinas is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, disability or protected veteran status.