Reports To: Senior Vice President, Research & Development
Location: Remote Work (US Only)
The Vice President is responsible for the clinical development strategy across Sabin’s current vaccine candidates (e.g., prophylactic monovalent vaccines to protect against Ebola Sudan and Marburg viruses) and future vaccine pipeline. The Vice President will anticipate challenges and obstacles, conduct risk/benefit assessment, and provide needed solutions and develop and implements an integrated clinical trial program to include protocol design, medical oversight of ongoing studies, and management of a team of patient safety and clinical operations staff. As Sabin’s subject matter expert (SME) on clinical development, the incumbent will advise on all internal medical matters to achieve program goals within established timelines and according to predetermined budget, support regulatory interactions for product advancement, obtain scientific advisory input and work with biostatisticians for Phase 1-4 design and analyses. The Vice President will be the lead representative on all external clinical-related matters to investigators, regulatory authorities, partners, funders and CROs. Sabin is proactively growing its pipeline and the successful candidate will play a key strategic role in expanding the vaccine portfolio, including due diligence of clinical programs.
- Design and execute Sabin’s clinical strategy in support of vaccine development for early and late-stage vaccine candidates; identify core issues and obstacles and proactively provide solutions
- Author and implement the clinical development plan for all development programs
- Manage and lead the clinical development team, including full time employees and consultants
- Ensure adherence to all applicable clinical regulatory requirements, including Good Clinical Practices (GCP), International Conference on Harmonization (ICH), country-specific regulations for clinical sites, and internal SOPs (such as electronic records, patient protections, IRB procedures, data stewardship, etc.)
- Oversee all aspects of clinical program, including safety (approve safety reports) and surveillance, clinical operation activities; manage staff responsible for executing work plan
- Establish and nurture relationships with high-level counterparts at clinical CRO, lead investigators at clinical sites in the US and Africa, and clinical SMEs at BARDA, NIH/VRC, and WHO and CEPI; establish regular meetings with these organizations and present as needed.
- Partner with regulatory team (internal and external consultants) on clinical trials (operations, data and safety), author/maintain clinical sections for all regulatory submissions (e.g., IB, IND sections, annual report) and funder reports (BARDA)
- Provide critical interpretation of completed clinical trial results for important go/no-go decisions and regulatory submissions
Author/update all clinical portions of regulatory filings/communications, grant proposals and presentations, etc.
- Work cross-functionally with R&D team to ensure progress of the product development plan, develop/refine target product profile and vaccine development strategy throughout the product life cycle
- Represent Sabin in clinical-focused discussions, meetings and presentations with clinical sites, consultants/vendors, funders (currently BARDA), partners (currently VRC), regulatory authorities (in-country and US), and global organizations (WHO, CEPI); prepare/finalize meeting presentations (ppt) and reports, and contribute to reporting deliverables to funders
- Collaborate with team members to prepare communications, publications and presentations for external meetings
- Manage clinical budgets for each program; work with project management team to ensure funder compliance
- Oversee management and governance of external consultants/vendors that support Sabin’s clinical trials
- Participate in Senior Management Team (SMT) activities and meetings and contribute to SMT initiatives
- Support Sabin’s work environment focused on quality and foster learning, respect, open communication, collaboration, integration, and teamwork
- Supervise, mentor, coach and train team members, as assigned
- Represent Sabin and promote its mission at events and meetings
- Other related duties, as assigned
- US Medical Doctor (or equivalent degree from non-US institution) with 16 years’ experience, including 10 years relevant clinical experience in product development with an emphasis on vaccines
- Experience managing clinical trials in low-or middle-income countries strongly preferred, (particularly Africa)
- Experience in pre-market clinical safety and pharmacovigilance and clinical operations
- Broad and extensive clinical development experience across all phases of vaccine product development
- Extensive knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review
- Comprehensive knowledge of and experience with FDA clinical regulatory requirements and ICH/GCP guidelines in vaccines; knowledge of non-US clinical regulatory processes
- Proven successful track record in leading and managing high performing teams to obtain regulatory approval in the US and/or EU; Animal Rule experience a plus
- Proven experience in the design and conduct of global vaccine clinical trial programs
- Must possess the ability to provide scientific and clinical expertise to a clinical development program; and evaluate scientific and clinical strategies to obtain regulatory approval
- Previous work on a large USG contract and/or philanthropic grant is preferred
- Demonstrated consistent achievement of team delivery against commitments and goals
- Strategic thinker and creative problem-solver capable of identifying risks and risk mitigation strategies
- Possess excellent teamwork, negotiation and influencing skills, able to work in a matrix project team setting
- Excellent verbal and written communication skills
- Strong scientific writer and oral presenter
- Experience with communicating organizational goals and objectives to employees, funders, and partners
- Ability to travel domestically and internationally with notice
- 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
- Communication and Professionalism
- Initiative and Ownership
- Productivity and Quality Control
- Professional Development/Personal Learning
How to Apply:
To be considered, please submit your cover letter and resume via e-mail to email@example.com. Please be sure to reference “Vice President, Clinical Development” 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.
About Sabin Vaccine Institute
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.