Vice President, Clinical (Research & Development)

Reports to: President, R&D

Location: Remote Work

Why Sabin:

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 the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary: 

The Vice President of Clinical (VP) reports to the President, R&D and is a key member of the R&D Leadership Team (LT). The VP 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, always demonstrating a commitment to excellence. The Vice President anticipates challenges and obstacles; conducts risk/benefit assessment and provides needed solutions; and develops and implements an integrated clinical trial program to include protocol design, medical oversight of ongoing studies, and management of the patient safety and clinical operations team. As Sabin’s subject matter expert (SME) on clinical development, the VP advises on all internal medical matters to achieve program goals within established timelines and according to predetermined budget, supports regulatory interactions for product advancement, obtains scientific advisory input, and works with biostatisticians for Phase 1-4 design and analyses. 

The Vice President is 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.

Responsibilities:

R&D Leadership

• Be an active member of the R&D Leadership Team that drives the culture, strategy and pipeline execution of Sabin R&D
• Set an example for all R&D staff by demonstrating integrity, a passionate and positive attitude, commitment to working collaboratively with other members of the R&D LT and staff and unwavering dedication to Sabin’s mission and development programs
• Work with R&D LT and Sabin executive leadership to set strategic goals and objectives for Sabin programs, portfolio and strategy. 
• 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 
• Advise and support all cross-functional needs (Regulatory, CMC, Quality, Clinical Project Management, Finance, etc.)
• Contribute to reporting deliverables to Sabin’s R&D Committee, regulators and funding agencies/organizations
• Support budget development and staffing projections
• Attract, recruit qualified talent, supervise, mentor, coach and train team members, as assigned

Clinical Development

• 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 product development programs
• Manage and lead the clinical development team, including full-time employees and consultants (covered in another bullet) 
• 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; data management; biostatistics; manage staff responsible for executing work plan
• 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
• Provide critical interpretation of completed clinical trial results for important go/no-go decisions and regulatory submissions
• 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

Collaboration/Partner Management

• 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, WHO and CEPI; establish regular meetings with these organizations and present as needed. 
• 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
• Provide leadership, expertise and scientific direction from clinical and other areas of expertise perspective in association with cross-functional teams
• Oversee identification, management and governance of external consultants/vendors that support Sabin’s clinical trials 
• Perform data analysis and prepare or review final reports for studies conducted by third parties
• Generate, manage and execute program deliverables on time and in budget
• Exercise cost-effective quality and regulatory compliant methods in selecting program partnerships and involve all stakeholders in driving decisions

Business Development

• Work in collaboration with Sabin executive and R&D LT to support growth of product pipeline; strategy development and      external relationship development
• Participate in due diligence activities and lead clinical assessment of vaccine candidates
• Use business network to identify possible vaccine candidates for further development by Sabin
• Participate in identification of and responding to external funding applications; lead all clinical portions of applications

Organizational Management

• Participate as a key member of the Sabin R&D Leadership Team
• Supervise direct reports and reflect Sabin’s supervisor goals
• Support Sabin’s work environment focused on quality and foster learning, respect, open communication, collaboration, integration, and teamwork
• 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

Other:

• Must demonstrate interest in furthering Sabin’s mission
• Subject to a criminal background investigation
• Request for three professional references
• Verification of education/degrees

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 $325,000 - $365,000. 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