Director, Clinical Operations

CytomX Therapeutics, Inc.•Emeryville, CA

3d•$225,000 - $245,000•Hybrid

About The Position

CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel PROBODY® therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engagers, and immune modulators such as cytokines. CytomX’s clinical-stage pipeline includes CX-2051 and CX-801. Learn more at www.cytomX.com.

Requirements

Bachelor’s degree in a life-sciences, health-sciences, nursing, pharmacy, or related field, or an equivalent combination of relevant education and experience.
8 years of progressive clinical-operations experience in biotechnology or pharmaceutical drug development with at least 5 years of leadership of complex, multi-site clinical trials and oversight of CROs and vendors.

Nice To Haves

Demonstrated people-management experience, including setting expectations, coaching, performance feedback, development planning, and delegation.
Working knowledge of Good Clinical Practice and applicable clinical-trial regulations, with experience applying quality and risk-based approaches to study execution.
Demonstrated ability to manage study plans, budgets, forecasts, timelines, operational metrics, risks, and cross-functional decisions with a high degree of independence.
Experience in oncology clinical development and in studies progressing from early development toward Phase 2 or Phase 3 readiness.
Experience with global study start-up, site activation and enrollment strategy, TMF oversight, clinical-sample operations, and clinical drug-supply coordination.
Experience leading inspection-readiness activities, process improvement, SOP development, and implementation of clinical-operations systems or analytics tools.
Experience communicating clinical-operations strategy, risks, and recommendations to senior governance forums.

Responsibilities

Lead end-to-end clinical operations for assigned global studies, including operational planning, start-up, site activation, enrollment, study conduct, closeout, and inspection readiness.
Translate program and protocol strategy into integrated operational plans, timelines, budgets, resourcing models, risk assessments, quality measures, and decision points.
Independently manage approved study and team resources; monitor forecasts and actuals, identify variances, and recommend actions that protect quality, timelines, and responsible use of resources.
Select, contract with, and oversee CROs and other vendors. Establish performance expectations, governance, metrics, escalation pathways, and corrective actions.
Partner with cross-functional stakeholders to ensure operational feasibility, timely study-document finalization, site selection and activation, data review, clinical-sample flow, drug-supply continuity, and regulatory deliverables.
Use operational data and leading indicators to assess enrollment, monitoring, data entry and verification, queries, action items, TMF completeness, sample reconciliation, and vendor performance; drive timely risk mitigation and escalation.
Ensure studies are conducted in accordance with applicable protocols, GCP, regulatory requirements, quality standards, contracts, and internal procedures. Support audits, inspections, and issue remediation.
Lead development and continuous improvement of clinical-operations infrastructure, including SOPs, work instructions, tools, templates, dashboards, and scalable ways of working for later-phase readiness.
Participate in functional and cross-functional strategy, governance, and portfolio discussions. Present concise operational recommendations, tradeoffs, risks, and decisions to senior stakeholders.
Manage, coach, and develop employees. Set clear goals and decision rights, provide timely feedback, support development plans, recognize performance, and build an inclusive, accountable, high-performing team.
Delegate appropriately while maintaining oversight of critical decisions, commitments, quality, and delivery. Foster collaboration and prompt resolution of conflicts and operational issues.