Job Description
Lead transformative medical initiatives at the intersection of clinical excellence and strategic innovation. As Senior Medical Director at Apex Healthcare Innovations, you'll shape our therapeutic pipeline while mentoring cross-functional teams to deliver breakthrough treatments. Join us in redefining patient care through data-driven decision making and cutting-edge research methodologies.
Responsibilities
- Oversee clinical trial design, execution, and regulatory compliance for 15+ therapeutic programs
- Develop strategic partnerships with leading research institutions and pharmaceutical partners
- Lead FDA/EMA submissions and ensure adherence to ICH-GCP guidelines
- Mentor 8-person medical affairs team through performance coaching and career development
- Represent company at global medical conferences and advisory board meetings
- Drive pharmacovigilance initiatives and risk management protocols
- Collaborate with commercial teams to develop evidence-based market access strategies
Qualifications
- MD/DO with 10+ years of clinical research leadership experience
- Board certification in relevant therapeutic specialty (Oncology/Cardiology preferred)
- Proven track record of successful FDA/EMA submissions and inspections
- Expertise in ICH-GCP, GMP, and clinical trial management systems (CTMS)
- Strong publication record in peer-reviewed medical journals
- Experience managing multi-million dollar research budgets
- Exceptional stakeholder management across C-suite, physicians, and regulators
- Proficiency in statistical analysis and clinical data interpretation