Medical Affairs Lead

The Medical Affairs Lead will act as a key scientific partner to Commercial and Market Access teams, ensuring that all strategic commercial decisions, regulatory interactions, and external engagements are grounded in robust medical and scientific evidence.

The position plays a critical role in supporting product recommendation, enabling market access, and driving evidence-based adoption of vaccines in tenders and other procurement channels, while maintaining strict scientific independence and compliance with non-promotional standards.

1. Medical Strategy w/Commercial Impact

• Execute medical strategies aligned with portfolio, commercial priorities, and public health needs
• Translate scientific evidence into value-relevant narratives supporting access, positioning, and uptake
• Develop training materials and deliver training to HCPs and partners,
• Initiate, co-ordinate, assess and maintain oversight of clinical and investigator led studies for the product portfolio. 
• Act as medical partner to Commercial leadership for franchise strategy (Men4, Tdap, MenB, Men5 pipeline)

2. Regulatory, Policy & Market Access Enablement

• Provide medical leadership in registration processes, with focus on enabling timely and successful market entry
• Engage directly with NITAGs, regulatory/endorsement agencies, and public health stakeholders
• Support value-based discussions, including
• Clinical data interpretation for access and pricing discussions
• Scientific justification for bridging strategies and study requirements
• Work closely with Regulatory and Market Access teams to align scientific arguments with market needs

3. Evidence Generation Aligned to Access & Adoption

• Lead evidence generation plans supporting both regulatory requirements and market adoption, including:
• Data gap identification relevant for HTA and NITAG decision-making
• RWE, epidemiology, and post-marketing evidence
• Ensure evidence supports differentiation, reimbursement, and policy inclusion

4. External Scientific Engagement

• Lead scientific exchange with key external stakeholders, including:

o   Public health authorities

o   NITAG members and advisors

o   Key opinion leaders and scientific societies

• Represent the company in high-level medical and policy discussions supporting vaccine adoption and guidelines
• Setting up advisory boards & expert board meetings as may be relevant

5. Cross-functional Partnership

• Cross-functional collaboration with Marketing and Market access for the development of reimbursement dossiers and publications
• Support development of commercial strategies with robust scientific underpinning
• Provide medical review and approval of customer-facing materials and training content

6. Governance & Medical Independence

• Ensure all activities remain fully compliant with medical, regulatory, and ethical standards
• Maintain clear separation between scientific exchange and promotional activities
• Safeguard credibility with external stakeholders through unbiased medical input

• Medical degree (MD or equivalent) is highly preferred OR relevant work experience to substantiate the qualification for the position
• Additional qualification (e.g., MPH, PhD, specialization in infectious diseases, vaccinology) – is a plus

3 - 7 years of experience in:

o   Medical Affairs, Clinical Development, or Regulatory/Scientific roles in pharma/biotech

o   Or relevant clinical/public health experience with exposure to vaccines or infectious diseases

• Experience or strong interest in vaccines, immunology, or public health

Skills & Competencies

• Strong ability to interpret clinical data and translate into business-relevant insights
• Strong external stakeholder engagement skills
• Experience or exposure to regulatory processes and interactions with health authorities or advisory bodies (e.g., NITAGs)
• Understanding of market access and commercial drivers in vaccines
• Knowledge of HTA processes, access, and evidence requirements
• Ability to work cross-functionally in a multi-site organization
• Balancing scientific integrity with business needs
• Fluent in English; additional European languages are beneficial

Preferred Experience

• Prior experience in vaccines (Meningococcal, Tdap or combination vaccines preferred)
• Exposure to European and regulated markets (EMA or national agencies)
• Experience working with public health institutions, NITAGs, or policy bodies
• Experience in evidence generation planning (RWE, epidemiology, post-marketing studies)

• A competitive salary between scale 11 & 12 (€4.535 – €8.248 per month based on experience and a workweek of 36 hours).
• A mission-driven culture aligned with global health security and pandemic preparedness.
• Competitive compensation package with performance-based incentives.
• Flexible working environment and strong support for personal development.
• Access to world-class technical capabilities through collaboration with SII experts.

Bilthoven Biologicals is an international biopharmaceutical manufacturing company.

Together with approximately 500 colleagues, we work on the production of vaccines, including polio, diphtheria-tetanus-polio (DTP), and BCG vaccines.

BBio supplies vaccines to organizations such as the World Health Organization (WHO) and UNICEF, thereby contributing to the global effort to eradicate polio worldwide.

BBio is part of the Poonawalla Group, owner of the Serum Institute of India, the world's largest vaccine manufacturer.

In addition, BBio continues to invest in the modernization and expansion of its production capacity.

Bilthoven Biologicals is een internationaal biofarmaceutisch productiebedrijf.
Met circa 500 collega's werken we samen aan de productie van vaccins, zoals polio-, difterie-tetanus-polio (DTP) en BCG.
BBio levert vaccins aan onder andere de World Health Organization (WHO) en UNICEF en helpt zo mee aan het wereldwijde programma om polio de wereld uit te helpen.
BBio maakt deel uit van de Poonawalla Group, eigenaar van het Serum Institute of India, de grootste vaccinproducent ter wereld. 
Daarnaast investeert BBio in modernisering en uitbreiding van onze productiecapaciteit.