Senior Director, Vaccine Development Team Lead (VDTL)

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 Senior Director, Vaccine Development Team Lead (VDTL) will be accountable for end-to-end strategy and execution of the vaccine development plan, managing the multi-disciplinary Vaccine Development Team, ensuring resource planning / allocation and adherence to quality and regulatory standards, identification and mitigation of risks, and plays a key role in communication and collaboration with both internal and external stakeholders. VDTL will oversee cross-functional efforts to advance vaccine candidates from mid-stage development through licensure and post-marketing commitments/requirements. 

This role requires strong leadership in coordinating scientific, technical, and operational activities across CMC, nonclinical, and clinical domains. The VDTL will drive strategic planning, ensure alignment with program goals, manage timelines and resources, and serve as the primary point of contact for internal stakeholders and external partners. A deep understanding of product development processes, regulatory requirements, and team management is essential for success in this role to ensure success of the Sabin vaccine candidates and the VDTL will leverage their robust set of experiences and qualifications to achieve this objective, always demonstrating a commitment to excellence. As Sabin works to proactively expand its project pipeline, the Senior Director works with other R&D Leadership Team (LT) members to develop and implement a long-term pipeline strategy and identify and evaluate assets for development. 

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. 
• Contribute to reporting deliverables to Sabin’s Board of Trustees 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

Vaccine Development 

• Partner closely with the Principal Investigator / Program Manager to establish overall program strategy, operational plans, and budgets, ensuring alignment with scientific and business objectives
• Develop and/or implement Target Product Profile (TPP) and Integrated Product Development Plan (IPDP) in alignment with program strategies, milestones, and organizational objectives
• Lead cross-functional teams to drive vaccine candidates through preclinical, clinical, and regulatory milestones and ensure progress of the product development plan aligned with the TPP and IPDP throughout the product life cycle 
• Facilitate cross-functional planning of vaccine development program activities across departments and disciplines to align dependencies, schedules, and funding
• Facilitate scientific and strategic decision-making by integrating data from multiple disciplines
• In coordination with the Vaccine Development Lead, plan and facilitate high-impact and alignment driving cross-functional meetings, governance reviews, and decision making that align stakeholders and advance program objectives
• Monitor project risks and implement mitigation strategies to maintain progress and quality standards
• Prepare and deliver program updates to Executive Management, Board of Trustees and governance committees and external funding partners or stakeholders
• Facilitate and oversee cross-functional collaboration to maintain regulatory compliance throughout program execution
• Identify and report program risks, and support mitigation actions and contingency plans 

Collaboration/Partner Management 

• Work closely with project managers, Product Development Team members, contract manufacturing and research organizations, subcontractors, suppliers and consultants, to ensure appropriate standards are implemented and maintained across all program activities
• Participate in meetings with contractors, partners and funders, including biweekly meetings with the Biomedical Advanced Research and Development Authority (BARDA); prepare and present program- and contract-related meeting materials
• Draft and/or review documents or sections of documents to support continued product development (e.g., clinical trial applications, investigator brochures, etc.), regulatory activities for licensure and/or World Health Organization (WHO) prequalification (e.g., investigational new drugs (INDs), marketing applications, etc.), and grant/funding applications
• Serve as subject matter expert (SME) for vaccine-related matters and provide expert vaccine representation during discussions with regulators, funders and global health stakeholders (e.g., WHO, Gavi and Coalition for Epidemic Preparedness Innovations (CEPI))
• Participate in due diligence activities to expand the R&D pipeline

Organizational Management

• Support Sabin’s work environment focused on quality and foster learning, respect, open communication, collaboration, integration, and teamwork
• Ensure compliance with internal and external policies and regulations, as applicable
• Represent Sabin and promote its mission at events and meeting
• Other related duties, as assigned

•  Minimum bachelor’s degree in biochemistry, chemistry, biology, chemical engineering or related pharmaceutical science required, advanced degree highly desired
• 14+ years’ experience in biopharmaceutical product development, preferably with direct experience in vaccine or other biological medical countermeasure development
• Comprehensive technical understanding of the inter-disciplinary nature of vaccine and or other biologic product development
• Demonstrated previous successful product development experience of mid-to-late stage candidates (Phase 2 and Phase 3 Clinical Trials) to licensure and, ideally, managing post-marketing commitments and requirements
• Experience managing large, advanced development and procurement contracts from the U.S. Government (ideally BARDA)
• Demonstrated strong project management skills, experience in earned value management (EVM), and preferably holding a PMP certification, to drive cross-functional coordination and ensure timely, budget-conscious delivery of vaccine development milestones
• Past involvement with filovirus countermeasures highly desired
• In-depth understanding of US and EU pharmaceutical/CMC regulations Comprehensive working knowledge of current Good Manufacturing Practices (GMPs) and regulatory guidance related to product development
• Experience in drafting sections for INDs, NDAs, and -ex US equivalents; experience with products licensed via Animal Rule and/or Accelerated Approval desired
• Ability to manage complex tasks, prioritize competing objectives and work well under pressure
• Strong attention to detail; highly organized and dependable
• Exemplary verbal and written communication and presentation skills; ability to distill complex, highly technical product development requirements and strategies
• Demonstrated ability to operate with purpose, urgency, and accuracy in a fast-paced and deadline-driven environment

Other:

• Must demonstrate interest in furthering Sabin’s mission
• Ability to travel domestically and internationally with notice
• 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 $205,000 - $235,000. 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.