Reports to: Vice President, Clinical Operations
Oversee clinical trial execution and manage clinical data contributions to advance Sabin’s vaccine candidates towards regulatory authorization and/or licensure
Manage clinical trial vendors and CROs to ensure Sabin’s trials comply with Good Clinical Practices (GCPs), Good Clinical Laboratory Practices (GCLPs), Good Pharmacovigilance Practices (GPVPs) and applicable international and country-specific regulations
Actively manage clinical operations; collaborate with the CRO to develop a robust and integrated risk management program in accordance with ICH E6 (R2)
Accountable for management of all clinical operation activities including proactive identification of work streams and dependencies, key risk indicators, resources, and milestones
Collaboratively oversee quality audits of CROs and investigational sites
Manage clinical trial materials logistics: investigational product labeling, shipping and storage, as well as sample collection and logistics from clinical sites
Responsible and accountable for ensuring accurate and up-to-date study and program information within relevant tracking systems and providing regular updates; proactively identify, risk-manage, and resolve issues that arise during study and program conduct; manage escalation of study and program-related issues
Contribute to the development of clinical trials related documentation including Investigator Brochures, trial master files, clinical study reports, protocols, and protocol amendment and patient-facing documents (e.g., informed consent forms)
Plan, coordinate, control and continuously improve processes and systems to assure quality and compliance of clinical studies; provide input and change management for quality improvements
Ensure proper performance of clinical data management, including proper implementation of electronic data capture for every trial, creation of eCRF/EDC Specifications and database design and build
Working with regulatory affairs, contribute to the review of IND, EUA and BLA submissions as required to ensure data and documents meet GCP guidelines; perform quality and compliance checks of relevant clinical documents and regulatory dossiers (e.g., Investigator's Brochure, CRF, Clinical Study Reports and clinical sections in IND/EUA/BLA/MAA submission) to ensure data integrity and accuracy
Contribute to the development of funding proposals, clinical product development plans and protocols
Support Sabin’s work environment focused on quality and foster learning, respect, open communication, collaboration, integration, and teamwork
Ensure compliance with internal and external policies and regulations, as applicable
Represent Sabin and promote its mission at events and meetings
Other duties as assigned

Requirements

Minimum bachelor’s degree in biochemistry, chemistry, biology, chemical engineering or related pharmaceutical science required
Must have at least 12 years of direct clinical trial management experience, ideally covering all clinical phases
Broad knowledge of clinical processes and procedures, electronic documentation systems, and GCP, GCLP and GPVP regulations/guidance with demonstrated effectiveness in maintaining CQA control processes for compliance with regulations
Ability to oversee clinical protocol implementation and the development of trial supporting documents, budget oversight and decision-making experience
Experience handling confidential and sensitive information; ability to exercise discretion
Hands-on knowledge of technologies and database solutions that assist in the efficient conduct of clinical trials and long-term data archiving
Skilled in developing collaborative internal and external relationships with experience in building teams, through coaching and development
Experience in drafting clinical sections for regulatory documents including INDs, DSURs, BLAs/NDAs, and -ex US equivalents
Continuously demonstrates a positive, 'can do' and service-oriented attitude
Strong attention to detail; highly organized and dependable
Excellent interpersonal, verbal and written communication skills with commitment to accuracy
Demonstrated ability to think critically and demonstrate troubleshooting and problem-solving skills
Demonstrated ability to operate with purpose, urgency, and accuracy in a fast-paced and deadline-driven environment
Ability to travel domestically and internationally with notice
Proficient in Microsoft Office applications (Excel, Outlook, PowerPoint, Word, Teams); MS Project a plus
Subject to a criminal background investigation
Request for three professional references
Verification of education/degrees

Benefits

Medical, Dental, Vision and Flexible Spending Accounts
Employer paid, Life and Disability insurance
11 paid holidays with a winter break between Christmas and New Years
Employer match on 401(k)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical trial managementGood Clinical Practices (GCP)Good Clinical Laboratory Practices (GCLP)Good Pharmacovigilance Practices (GPVP)electronic data captureeCRF/EDC specificationsdatabase designclinical protocol implementationregulatory document draftingclinical data management

Soft skills

collaborationteam buildingproblem-solvingattention to detailorganizational skillsinterpersonal communicationcritical thinkingdiscretionservice-oriented attitudeadaptability