Director, Clinical Operations (Research & Development)

Reports to: Vice President, Clinical Development

Location: Remote Work

Term: USG funding through Clinical Trials with possibility for extension pending additional funding

Position Summary: 

The Director 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.

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 investigation 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
• Establish and implement a long-term data management strategy across all clinical trials to benefit Sabin vaccines portfolio
• Contribute to developing 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 
• Provide oversight of the data management vendor, including proper implementation of electronic data capture for every trial, creation of eCRF/EDC Specifications and database design and build
• Ensure robust data management plan (DMP) at CRO
• Contribute to the development of funding proposals, clinical product development plans and protocols
• 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

• Advanced degree in a related field
• 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
• 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
• Demonstrated ability to think critically and demonstrate troubleshooting and problem-solving skills
• Ability to travel domestically and internationally with notice

Other:

• Subject to a criminal background investigation
• Request for three professional references
• Verification of education/degrees

Attributes that Are Important to Sabin:

• Diversity, Equity and Inclusion
• Problem-Solving and Critical Thinking
• Decision-Making
• Communication and Professionalism
• Initiative and Ownership
• Productivity and Quality Control
• Professional Development/Personal Learning

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 $165,000 - $200,000. 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.