Senior Manager, Clinical Operations (Research & Development)

https://www.sabin.org/

About the organization

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.

Duties

The Sabin Vaccine Institute (Sabin) is seeking a Senior Manager, Clinical Operations to join its Vaccine Research & Development (R&D) Team. The Senior Manager will be responsible for the planning and execution of Phase 1-3 clinical trials, including protocol preparation, study setup and execution, vendor management and sponsor oversight activities.

Clinical/Partner Management
• Serve as the main point of contact for day-to-day clinical operations activities
• Provide strategic input and leadership in study setup and execution
• Manage the RFP process, study contract/budget development and study forecast/planning, including timelines
• Manage CRO, central lab, systems and ancillary vendors to ensure deliverables are on time and in budget
• Lead cross-functional study teams
• Develop protocols, study plans and relevant document templates for study teams
• Manage clinical study stakeholders, including internal business partners, key opinion leaders and external partners

Organizational Management
• Ensure compliance with internal and external policies and regulations, as applicable
• Support pipeline strategy development and external relationship development

Qualifications

• Bachelor’s degree in a related field, scientific or healthcare discipline preferred
• Minimum 9 years of relevant experience, preferably clinical development in the pharmaceutical or biotech industry
• Demonstrated experience managing all phases of clinical studies and conducting clinical trials in Africa
• Thorough understanding of FDA, other regulatory, ICH and GCP guidelines as well as cross-functional clinical processes, including data management, biostatistics, medical monitoring, drug safety, regulatory affairs
• Experience with compound lifecycle from IND to NDA preferred
• Experience with protocol development required
• Experience with regulatory compliance audits and inspections preferred
• Experience with U.S. Government funded vaccine R&D preferred
• Infectious disease experience preferred
• Ability to identify risks and skilled at contingency planning preferred
• Proficient in all Microsoft Office applications and organizational tools
• Proven ability to manage in a complex team environment, build relationships, collaborate and understand what motivates others
• Excellent verbal and written communicator with ability to tailor approach toward the perspective of others; produce compelling presentations and accurate reports
• Strong attention to detail, ability to manage complex tasks, highly organized, dependable and able to prioritize competing demands in order to meet deadlines
• Ability to travel with notice

Salary

Salary commensurate with qualifications and experience.

Application instructions

Contact email: [email protected]

To be considered, please submit your cover letter and resume via e-mail to [email protected] Please be sure to reference “Senior Manager, Clinical Operations” 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.

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Equal Opportunity Employment

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