Senior Medical Director, Clinical Development - Respiratory

Summary

Join Apogee Therapeutics, a well-funded Nasdaq-listed biotechnology company, as a Sr. Medical Director to contribute to the strategy and oversee the clinical and medical execution of respiratory programs. You will lead study design, drive the path to registration, and ensure seamless study execution. This role involves collaboration with cross-functional teams, building relationships with key opinion leaders, and serving as the primary point of contact for sites and PIs. For candidates with management experience, overseeing a small team will be part of the responsibilities. The position requires up to 20% travel. Apogee offers a competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits, flexible PTO, and two company-wide shutdowns annually.

Requirements

• MD required
• At least 3 years industry experience as medical monitor and/or medical director, working in clinical development
• Respiratory clinical development experience is required
• Knowledge of all phases of drug development, particularly phase 2 and beyond clinical development
• Experience as the clinical development representative on cross functional drug development teams
• Strong communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Experience filing Investigational New Drug applications and/or Biologics License Applications

Responsibilities

• Contribute to the clinical development plan from proof-of-concept studies through BLA
• Lead study design
• Oversee day-to-day clinical and medical execution of studies, supporting medical monitors, working closely with the CRO, clinical operations and pharmacovigilance on study execution including safety reporting
• Work closely with cross functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan
• Partner with clinical operations on site selection, recruitment, and CRO management
• Build and maintain strong relationships with PIs and KOLs
• Serve as primary point of contact for sites and PIs
• Support development of the overall clinical strategy for the company
• Support design of trials and develop protocols for individual studies

Preferred Qualifications

• Training in pulmonology and/or allergy
• Experience in other inflammatory and immunological therapeutic areas
• Experience leading and managing teams
• Emerging leader with a growth mindset, willing to mentor as well as learn from others

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve