Director, Clinical Operations job at Sabin Vaccine Institute in US National

Director, Clinical Operations Fully Remote Job Type Full-time Description Location: Remote Work, US Only Term: USG funding through Clinical Phase 2 Trials with possibility for extension pending additional funding Why Sabin: Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate. Position Summary: The Director, Clinical Operations is an operational leader who will oversee clinical trial execution and to conduct and manage clinical data contributions to advance Sabin’s vaccine candidates towards regulatory authorization and/or licensure. This role will 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. The work includes extensive cross-functional management to integrate multiple R&D workstreams towards a high-quality dataset to ultimately support vaccine licensure. Key Responsibilities: 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 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 Other: Subject to a criminal background investigation Request for three professional references Verification of education/degrees Sabin’s philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the starting annual salary for this position ranges from $168,000 - $203,000. The exact compensation may vary based on skills, experience, training, certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs. Sabin offers a competitive benefits package that includes Medical, Dental, Vision and Flexible Spending Accounts. Employer paid, Life and Disability insurance along with 11 paid holidays with a winter break between Christmas and New Years. Employer match on 401(k). Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws. Salary Description $168,000 - $203,000 Apply tot his job Apply To this Job