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.
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.
Sabin aims to drive vaccine candidates through FDA licensure; the Senior Manager will leverage their robust set of experiences and qualifications to achieve this objective.
Initially, Sabin’s R&D projects will focus on prophylactic candidate vaccines to protect against Ebola Sudan and Marburg virus funded by the U.S. Government. Sabin is taking proactive action to grow its project pipeline and the incumbent will be an important part of developing a long-term pipeline strategy, developing new project opportunities and project execution.
- 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
- Provide disease updates and analysis
- Perform scientific writing
- Ensure compliance with internal and external policies and regulations, as applicable
- Support pipeline strategy development and external relationship development
- Identify and manage outside subcontractors and consultants, as appropriate
- Preparation of meeting reports and PowerPoint presentations
- Contribute to reporting deliverables to funding agencies/funders
- Supervise, mentor, coach and train team members, as assigned
- Represent Sabin and promote its mission at events and meetings
- Other related duties, as assigned
- 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
- Demonstrated ability to operate with purpose, urgency and accuracy in a fast-paced and deadline-driven environment
- 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 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.
Salary commensurate with qualifications and experience. Sabin Vaccine Institute has a generous benefits package (see 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.