Key Responsibilities and Required Skills for Vaccine Director

🎯 Role Definition

The Vaccine Director serves as the strategic and scientific cornerstone for the organization's vaccine portfolio. This senior leadership position is accountable for providing end-to-end direction and expert oversight for vaccine development programs, guiding assets from late-stage preclinical research through the complexities of global clinical trials, intricate regulatory submissions, and successful commercialization. As the leader of a cross-functional program team, the Vaccine Director integrates scientific, clinical, regulatory, and commercial strategies to drive timelines, manage substantial budgets, and ultimately deliver safe and effective vaccines to address unmet public health needs. This individual is a key voice to executive leadership, external partners, and regulatory bodies, embodying the scientific rigor and strategic vision of our vaccine development mission.

📈 Career Progression

Typical Career Path

Entry Point From:

Associate Director, Clinical Development (Vaccines)
Senior Clinical Program Lead / Manager
Principal Scientist, Vaccinology / Immunology

Advancement To:

Senior Director, Vaccines / Head of Vaccines
Vice President, Clinical Development
Head of R&D or Chief Medical Officer

Lateral Moves:

Director, Regulatory Affairs (Biologics)
Director, Medical Affairs (Vaccines)
Director, Business Development (Vaccine Portfolio)

Core Responsibilities

Primary Functions

Provide strategic leadership and single-point accountability for one or more vaccine development programs, from candidate selection through Phase IV and lifecycle management.
Lead and manage a high-performing, cross-functional team (including Clinical, Regulatory, CMC, Preclinical, and Commercial) to ensure program goals are met on time and within budget.
Develop, maintain, and execute the integrated development plan (IDP) for assigned vaccine candidates, outlining the comprehensive strategy for bringing the asset to licensure.
Serve as the primary author and/or senior reviewer for critical clinical and regulatory documents, including study protocols, investigator's brochures, clinical study reports (CSRs), and sections of INDs/BLAs.
Oversee the design, implementation, and interpretation of data from all phases of clinical trials (Phase I-IV), ensuring studies are conducted in accordance with GCP and global regulatory standards.
Act as the primary interface and build strong relationships with global health authorities, including the FDA and EMA, leading the strategy for regulatory interactions and submission pathways.
Champion the vaccine program to internal governance bodies and executive leadership, presenting strategic updates, key data, risk assessments, and milestone progress.
Establish and manage relationships with key external stakeholders, including clinical investigators, academic collaborators, and Key Opinion Leaders (KOLs) to inform and validate development strategy.
Maintain a deep and current understanding of the scientific literature, competitor landscape, and evolving public health needs within the relevant infectious disease areas.
Drive the scientific and clinical components of the Target Product Profile (TPP) to ensure the development program is positioned for clinical and commercial success.
Exercise rigorous oversight of program budgets, resource allocation, and long-range financial forecasting, ensuring fiscal responsibility and alignment with corporate priorities.
Proactively identify, assess, and mitigate program risks related to scientific, clinical, regulatory, or operational challenges, developing robust contingency plans.
Collaborate closely with the CMC (Chemistry, Manufacturing, and Controls) team to ensure that manufacturing strategy and timelines are aligned with clinical supply needs and regulatory expectations.
Provide senior-level clinical and scientific input into business development activities, including due diligence for potential in-licensing of new vaccine assets or platform technologies.
Lead the preparation and presentation of clinical data at major international scientific conferences, advisory board meetings, and in peer-reviewed publications.
Ensure that all development activities are executed with the highest ethical standards and in full compliance with internal SOPs and external regulatory mandates.
Partner with Medical Affairs and Commercial teams to develop a comprehensive publication strategy and support activities for a successful product launch.
Foster a culture of innovation, collaboration, accountability, and scientific excellence within the program team and the broader R&D organization.
Mentor and develop talent within the clinical development team, providing guidance and growth opportunities for junior members.
Represent the company and its vaccine programs with authority and credibility to external partners, investors, and the broader medical community.

Secondary Functions

Represent the organization as a subject matter expert at key scientific congresses, public health forums, and advisory board meetings.
Contribute to the continuous improvement of clinical development processes, tools, and SOPs within the R&D function.
Participate in due diligence evaluations for potential in-licensing or acquisition opportunities to expand the vaccine pipeline.
Mentor junior clinical scientists and program managers, fostering the next generation of development leaders within the company.

Required Skills & Competencies

Hard Skills (Technical)

Deep expertise in vaccinology, immunology, virology, and/or infectious diseases.
Comprehensive understanding of the end-to-end drug and vaccine development lifecycle, from discovery to commercialization.
Proven track record of designing and executing clinical trial protocols (Phase I-III) for vaccines or biologics.
Expert knowledge of global regulatory environments (FDA, EMA, etc.) and submission processes for biologics (IND, BLA, MAA).
t- Thorough understanding and practical application of Good Clinical Practice (GCP), GxP standards, and ICH guidelines.
Experience in authoring and/or providing senior review of key regulatory and clinical documents.
Strong program management skills, with the ability to manage complex projects, budgets, and timelines.
Proficiency in interpreting complex clinical and preclinical data sets to make strategic decisions.
Familiarity with the Chemistry, Manufacturing, and Controls (CMC) aspects of vaccine production and scale-up.
Strong scientific and medical writing and publication experience in peer-reviewed journals.

Soft Skills

Exceptional strategic leadership and the ability to inspire and motivate cross-functional teams.
Superior verbal and written communication and presentation skills, with an ability to tailor messaging to diverse audiences (scientific to executive).
Strong negotiation, influence, and stakeholder management capabilities.
Advanced problem-solving and critical thinking skills, with a proactive approach to risk mitigation.
High level of accountability and decisiveness in a high-stakes, fast-paced environment.
Excellent interpersonal skills and a collaborative mindset for building consensus.
Business and financial acumen to manage large budgets and align programs with corporate financial goals.
Adaptability and resilience to navigate the uncertainties inherent in clinical development.

Education & Experience

Educational Background

Minimum Education:

Advanced scientific or medical degree (PhD, MD, PharmD)

Preferred Education:

MD or MD/PhD with clinical training in infectious diseases, pediatrics, or internal medicine; or a PhD in a relevant scientific discipline.

Relevant Fields of Study:

Immunology
Virology
Microbiology
Molecular Biology
Medicine
Pharmaceutical Sciences

Experience Requirements

Typical Experience Range: 10-15+ years of progressive experience in the pharmaceutical or biotechnology industry.

Preferred: A minimum of 7-10 years of direct experience in vaccine clinical development, including at least 5 years in a program leadership role with responsibility for cross-functional teams, budget oversight, and strategic planning. A proven history of successfully advancing at least one vaccine or biologic candidate through mid-to-late stage clinical development is highly desirable.