Job description
Join ApexBio Therapeutics, a leader in Specialized Medicine focused on transformative therapies for rare and complex diseases. Based in Boston, with global research partnerships, we seek a Senior Clinical Lead to drive medical strategy, oversee early and late-stage programs, and foster cross-functional collaboration.
In this role, you will partner with Clinical Development, Medical Affairs, Regulatory, and Commercial teams to shape program directions, develop evidence generation plans, and ensure patient-centric outcomes. You will mentor junior physicians and scientists, represent the company at key scientific congresses, and communicate complex data to diverse stakeholders.
We offer a hybrid work model, competitive compensation, comprehensive benefits, and generous opportunities for professional growth within a vibrant, mission-driven organization.
Responsibility
- Lead medical strategy and medical affairs alignment for specialized medicine programs across early and late-stage development.
- Collaborate with Clinical Development, Regulatory, Safety, and Commercial teams to shape trial design, endpoints, and statistical analysis plans.
- Oversee medical monitoring, safety oversight, and pharmacovigilance to ensure patient safety and data integrity.
- Develop and execute evidence-generation plans, publication strategy, and medical communications for internal and external stakeholders.
- Represent the company at scientific conferences, advisory board meetings, and external collaborations with investigators and key opinion leaders.
- Mentor and lead cross-functional teams, fostering a culture of scientific excellence and mentorship.
- Ensure compliance with GCP, regulatory requirements (FDA/EMA), and internal policies; manage risk and quality processes.
Qualification
- MD/DO or PhD in a relevant biomedical field; board certification preferred.
- Minimum 7-10 years of experience in clinical development, medical affairs, or translational medicine, with leadership exposure.
- Proven track record in specialized medicine or rare diseases; strong understanding of clinical trial design and regulatory expectations.
- Deep knowledge of GCP, FDA/EMA guidelines, pharmacovigilance, and safety monitoring.
- Excellent scientific communication skills; ability to translate complex data for diverse audiences and publications.
- Demonstrated leadership, collaboration across cross-functional teams, and stakeholder management; strong project management skills.
- Willingness to travel up to 20-30% for site visits, conferences, and partnerships.