Cullgen Inc. · 3 days ago
Senior Clinical Trial Manager (Contract)
SD Metro Area
Contract
Hybrid
Senior Level
5+ years expCullgen Inc. is a clinical-stage biopharmaceutical company focused on targeted protein degrader therapies. They are seeking an experienced Senior Clinical Trial Manager to oversee the planning and execution of US-based clinical trials, ensuring that all milestones and deliverables are achieved according to quality standards and timelines.
BiotechnologyMedicalPharmaceutical
Hiring Manager
Jessica Mendez
Responsibilities
Accountable for overall management of a Phase 1b/2a acute pain clinical trial
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, and completion of Trial Master File
Demonstrates consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors
Proactively identify and resolve issues that arise during the trial, maintaining a sense of urgency and attention to detail
Works cross-functionally to establish and ensure clinical trial timelines and goals are met and risks are appropriately escalated to Management
Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
Experienced in developing all Clinical trial plans including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets
Collaborate with the CRO in the collection, preparation, and review of regulatory documentation prior to study start-up
Responsible for the set-up of all third-party vendor specifications (i.e. PK analytics/kit build and Drug Depot) and on-time third party deliverables
Responsible for negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO
Responsible for vendor budget, invoice review and study scope changes
Accountable for eTMF – completeness, timeliness, and quality on assigned programs. Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files
Responsible for participating in and presenting at Investigator Meetings, SIVs and other program meetings
Provide monitoring oversight by conducting co-monitoring visits and reviewing CRO monitoring reports and deviations on an ongoing basis
Support trial-related audits and inspections as needed, ensuring complete and accurate documentation is available
Demonstrated success in managing teams, including mentoring Clinical Trial Associates or similar roles
Ability to travel 10-20% to US sites/vendors
Qualification
Required
Bachelor's degree with a minimum of 5-7 years of experience within the pharmaceutical, biotechnology industry with a minimum of 2 years of experience in Biotech industry strongly preferred
Two years experience independently managing Phase 1 - 3 trials
Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
Experience working in a fast-paced and dynamic environment
Experience in CNS and specifically acute pain trials a plus
Accountable for overall management of a Phase 1b/2a acute pain clinical trial
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, and completion of Trial Master File
Demonstrates consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors
Proactively identify and resolve issues that arise during the trial, maintaining a sense of urgency and attention to detail
Works cross-functionally to establish and ensure clinical trial timelines and goals are met and risks are appropriately escalated to Management
Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
Experienced in developing all Clinical trial plans including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets
Collaborate with the CRO in the collection, preparation, and review of regulatory documentation prior to study start-up
Responsible for the set-up of all third-party vendor specifications (i.e. PK analytics/kit build and Drug Depot) and on-time third party deliverables
Responsible for negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO
Responsible for vendor budget, invoice review and study scope changes
Accountable for eTMF – completeness, timeliness, and quality on assigned programs. Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files
Responsible for participating in and presenting at Investigator Meetings, SIVs and other program meetings
Provide monitoring oversight by conducting co-monitoring visits and reviewing CRO monitoring reports and deviations on an ongoing basis
Support trial-related audits and inspections as needed, ensuring complete and accurate documentation is available
Demonstrated success in managing teams, including mentoring Clinical Trial Associates or similar roles
Ability to travel 10-20% to US sites/vendors
Preferred
Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
Experienced with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
Excellent presentation skills and the ability to present scientific information to varied audiences
Excellent computer skills and standard Microsoft Office Suite (Word, Excel, PowerPoint)
Excellent written, verbal and face-to-face communication to present information internally and externally as needed
Excellent organizational and time management skills
Strong critical thinking and problem-solving skills
Detailed oriented
Company
Cullgen Inc.
Cullgen is a biopharmaceutical company that has developed protein degradation technology that utilizes the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$106MKey Investors
AstraZeneca-CICC Venture CapitalGNI Japan3E Bioventures
2023-05-08Series C· $35M
2023-05-08Corporate Round· $5M
2021-02-25Series B· $50M
Leadership Team
Yue Xiong
Chief Scientific Officer
Recent News
GlobeNewswire
2026-01-07
2025-12-18
Company data provided by crunchbase