Job description
Join ApexMed Innovations, a leader in specialized medicine focusing on rare diseases and high-need therapeutic areas. We are seeking a Senior Medical Affairs Manager to drive scientific strategies, support clinical development, and build partnerships with key opinion leaders (KOLs). This role blends strategic medical leadership with hands-on execution across cross-functional teams in a fast-growing environment.
As a member of the Medical Affairs leadership team, you will shape the medical strategy, lead evidence generation plans, contribute to regulatory and market access activities, and support multiple product life cycles. You will engage with KOLs, design and deliver medical education programs, and ensure alignment with ethics, compliance, and regulatory standards.
We offer a competitive compensation package, comprehensive benefits, and a culture that values scientific excellence, patient outcomes, and professional growth.
Responsibility
- Develop and execute medical affairs strategy for specialized medicine programs in collaboration with Clinical Development, Regulatory, and Commercial teams.
- Lead scientific communications including advisory boards, publications, abstracts, and presentations to KOLs and internal stakeholders.
- Partner with Clinical Operations to design and oversee evidence generation plans, including real world evidence studies and registries.
- Provide medical input to regulatory submissions, labeling claims, and pharmacovigilance processes to ensure compliance and accuracy.
- Support market access through value dossiers, payer communications, and reimbursement strategies.
- Train and coach cross-functional teams on scientific messaging and compliant communications.
- Manage vendor relationships for medical education events and medical information services.
- Monitor the medical affairs program performance and adapt plans based on evolving data and regulatory requirements.
Qualification
- MD or DO or PharmD or PhD in life sciences with clinical or translational background.
- Minimum 7 years of progressive experience in Medical Affairs, Clinical Development, or Pharmacovigilance within specialized medicine, with preference for rare diseases.
- Proven track record of KOL engagement, scientific publications, and high-impact medical communications.
- Strong understanding of regulatory, pharmacovigilance, and compliance requirements including FDA/EMA guidelines.
- Experience in evidence generation methods including clinical trials, observational studies, registries, and real-world data.
- Excellent written and verbal communication, plus ability to present to senior leadership and external stakeholders.
- Advanced cross-functional collaboration skills; able to work in a matrixed organization and travel up to 25%.
- Fluent in English; additional languages a plus.