Clinical Trial Manager

Neomorph, Inc. · San Diego, CA · 2 wk ago

HybridResearchFull-time

About Us

Neomorph is a venture-backed biotechnology company solving critical problems in human health through the discovery and development of innovative new medicines against ‘undruggable targets’. Our team comprises industry-leading experts in protein degradation and molecular glues with a track record of groundbreaking discoveries in the field. We are committed to leadership in advancing the science and technology of molecular glue drug discovery, while prosecuting a pipeline of projects through clinical development. Our patient-first, science-driven approach is complemented by our dedication to a supportive and collaborative work environment. Neomorph is headquartered in San Diego, California.

Responsibilities

Lead the day-to-day operational management of assigned clinical trials from study start-up through close-out, with particular focus on early-phase oncology development.
Develop and maintain integrated study timelines, operational plans, trackers, and key performance indicators to ensure milestones are achieved.
Coordinate cross-functional study activities across clinical development, clinical operations, data management, biostatistics, regulatory, pharmacovigilance/safety, quality, CMC, translational, and other relevant functions.
Identify operational risks, escalate issues appropriately, and implement mitigation and contingency plans to protect study timelines, quality, and patient safety.
Support operational planning for dose-escalation and dose-expansion cohorts, including readiness for safety review and dose-escalation decision meetings, as applicable.
Manage and oversee CROs, clinical vendors, and consultants, with clear accountability for scope, timelines, deliverables, quality, and budget.
Monitor vendor performance using agreed metrics and governance processes; drive timely resolution of performance or quality issues.
Participate in vendor identification and selection, RFP processes, bid defenses, scope-of-work development, and contract review.
Oversee site feasibility, selection, activation, initiation, monitoring, and close-out activities conducted by CROs or monitors.
Review monitoring reports, enrollment metrics, site performance data, protocol compliance, and quality trends; ensure follow-up actions are completed.
Develop and support site engagement and enrollment strategies appropriate for competitive oncology indications and patient populations.
Partner with cross-functional teams and vendors to address site-level operational barriers, including recruitment, retention, sample logistics, and study drug supply.
Drive or support study start-up activities, including site feasibility, essential document collection, investigator meeting planning, and activation readiness.
Collaborate with Regulatory and CRO partners on submission-related activities, responses, and documentation for applicable health authorities and ethics committees/IRBs.
Manage assigned study budgets, forecasts, accrual inputs, and clinical trial expenditures in partnership with Finance and Clinical Operations leadership.
Review CRO and vendor invoices for accuracy, milestone achievement, and alignment with contractual terms; identify and resolve discrepancies.
Ensure clinical trials are conducted in compliance with ICH-GCP, applicable global regulatory requirements, protocol requirements, and company SOPs.
Support inspection and audit readiness, including timely identification, documentation, escalation, and remediation of quality issues.
Partner closely with internal stakeholders to ensure operational plans remain aligned with clinical development objectives and program priorities.
Provide clear, concise study status updates, risk assessments, and decision points to the VP of Clinical Operations and other senior leaders.
Contribute to the development and continuous improvement of clinical operations processes, tools, and infrastructure as the company grows.

Requirements

Bachelor’s degree in life sciences, nursing, public health, or related field required.
Advanced degree (MS, MPH, PharmD, or PhD, or equivalent) preferred.
7+ years of progressive experience in clinical research or clinical operations within biotech, pharmaceutical, or CRO environments.
Demonstrated experience managing Phase 1 and/or other early-phase clinical trials; study start-up and close-out experience strongly preferred; oncology trial experience strongly preferred.
Hands-on experience leading clinical trial execution balancing strategic oversight with detailed operational follow-through.
Proven experience managing CROs and external vendors including performance oversight, issue escalation, and budget accountability.
Working knowledge of oncology trial operations, including complex eligibility criteria, safety-intensive studies, dose-escalation/expansion designs, and time-sensitive site and data workflows.
Strong understanding of ICH-GCP, FDA requirements, and applicable global clinical trial regulations and processes.
Experience partnering with CMC and supply-chain stakeholders to support clinical supply readiness and continuity, including experience with clinical trial supply projections.
Experience partnering with clinical translation and pharmacology stakeholders to support clinical trial PK/PD sample collection, reconciliation, and troubleshooting.
Strong clinical trial financial management skills, including budget tracking, forecasting, accruals, invoice review, and change-order management.
Excellent project management, organizational, problem-solving, and communication skills, with the ability to manage multiple priorities in a fast-paced environment.
Ability to build effective relationships across functions and with external partners, influence without direct authority, and communicate clearly with senior leadership.
Experience helping build, scale, or optimize clinical operations processes and infrastructure is preferred.
Experience using AI to help create efficiencies and scale workload is a plus.

Schedule

This is a hybrid position based at our site in San Diego.

Travel Requirements: Up to 20%, including travel to investigator meetings, study sites, vendor meetings, or other clinical activities as needed.

Benefits