Reports to: Senior Vice President, Research & Development
Location: Washington, DC
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 Board of Trustees are committed to developing a diverse, equitable and inclusive team.
Senior Director, Clinical Trials and Clinical Quality Assurance (CQA) is responsible for providing leadership, strategic vision and efficient execution in managing compliance related to Good Clinical Practices (GCP's), Good Clinical Laboratory Practices (GCLP's), Good Pharmacovigilance Practices (GPVP's) and other related activities to deliver on Sabin's clinical goals.
The successful candidate will be a clinical trialist with strong critical and strategic thinking skills to oversee clinical trials, safety and clinical quality assurance activities associated with Sabin’s vaccine candidates. Current vaccine candidates are for Marburg and Ebola Sudan. This is an exciting opportunity for an individual with expertise to oversee clinical operations and safety under clinical development in the USA and globally to provide strategic GCP and GCLP compliance oversight. Effective communication and collaboration with internal and external stakeholders are a key requisite in this position.
Clinical Quality Assurance (CQA)
- Develop, implement and maintain GCP and GCLP quality oversight systems through enhancement and further implementation of an integrated quality system and development of procedures that follow 21 CFR Part 50, 56, and 312, along with ICH E6 and other relevant guidance documents; drive a robust risk-based contractor management program
- Oversee audit plans and activities, actively leverage audit outcomes/trends to achieve sustained improvement in clinical trial conduct and reporting while championing highest standards of compliance
- Work closely with Senior Director, Quality Assurance and CMC Oversight, who manages Sabin’s overall quality system, policy and both Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP), on inspection readiness activities, inspection conduct and preparation of responses to health authorities with a focus on data integrity
- Lead the CQA function while promoting a culture of quality by collaborating across all departments and levels of management to accomplish Sabin’s objectives
- Oversee clinical operations and clinical safety for GCP audits of internal processes; promote collaboration to ensure all systems, processes and outcomes comply with applicable international and national standards, regulations and guidelines
- Work collaboratively with GMP QA Operations Team to ensure manufacturing and packaging of clinical materials meet study and trial requirements
- Maintain CQA compliance for ongoing and planned clinical trials
- Perform GCP and GCLP training of employees
- Contribute to and assist SVP, R&D with development of funding proposals, clinical product development plans and protocols
- Oversee clinical operations and clinical safety and develop a robust and integrated risk management program in accordance with ICH E6 (R2), including systems and processes associated with product complaints
- Supervise Clinical Operations Director and Safety Director; hire, supervise and mentor other staff as team grows
- Evaluate quality events, incidents, queries and complaints to perform risk analysis on any GCP violation reported from clinical site or CROs (including CTM service provider), take actions to remediate, and communicate to senior management on overall compliance status
- Ensure documents are tracked and maintained within standards (e.g., trial master files, clinical study reports, protocols, proposals)
- 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 affecting CQA processes
- In coordination with Senior Director, Quality Assurance and CMC Oversight, create, maintain and revise department SOPs and documents that support the Quality Management System
- Work with regulatory affairs to prepare protocols and plans; contribute to and review 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
- Assess new and emerging (international) regulations relative to clinical trial planning and conduct and apply in a fit for purpose manner to Sabin's Quality Management System and practices
- Represent R&D and CQA; provide technical and quality updates as required at all levels of the organization
- Other related duties as assigned
- Medical degree or Master's degree equivalency in a science or health care field to include significant experience in an FDA-regulated environment
- 15+ years experience in the pharmaceutical industry with GCP focus, ideally covering all clinical phases, with at least 5 years in GCP quality/compliance role
- Broad knowledge of clinical processes and procedures, electronic documentation systems, and GCP, GCLP and GPVP regulations and guidance with demonstrated effectiveness in maintaining CQA control processes for compliance with regulations
- Experience conducting quality audits of CROs and investigational sites
- In-depth knowledge of FDA and ICH regulatory requirements; experience with African, EMA and/WHO regulations a plus
- Ability to oversee and develop clinical protocols and supporting documents; budget oversight and decision-making experience
- Experience handling confidential and sensitive information; ability to exercise discretion and show good judgment; demonstrates honesty, integrity and trust building behaviors in all situations
- Demonstrates initiative and proactively provides collaborative support to the Clinical Team as a credible communicator with a high degree of professionalism
- Ability to work with limited direction, dependable, flexible and able to prioritize competing demands in order to meet deadlines
- Continuously demonstrates a positive, 'can do' and service-oriented attitude
- Excellent interpersonal, verbal and written communication skills with commitment to accuracy
- Skilled in developing collaborative internal and external relationships with experience in building teams, through coaching and development
- Proficient in Microsoft Office application (Excel, Outlook, PowerPoint, Word); MS Teams a plus
- Ability to think critically and demonstrate troubleshooting and problem-solving skills
- Ability to travel with notice
How to Apply:
To be considered, please submit your cover letter and resume via e-mail to [email protected]. Please be sure to reference “Senior Director, Clinical Trials and Clinical Quality Assurance” in the subject line. Applications without a cover letter will not be considered. Your cover letter should: (1) address the reasons for your interest in this position; and, (2) describe the knowledge, skills, and abilities you would bring the Sabin Vaccine Institute. No phone calls, please. Only short-listed candidates will be contacted.
Salary commensurate with qualifications and experience. Sabin Vaccine Institute has a generous benefits package https://www.sabin.org/careers/employee-benefits.
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.