Senior Director, Head of Monitoring

Summary

Join Apogee Therapeutics as their Senior Director, Head of Monitoring, leading and growing their in-house clinical trial oversight monitoring team. This key leadership role involves overseeing CRO monitoring and site activities, fostering relationships with investigative sites, and ensuring consistent oversight across all Apogee studies. You will be accountable for line and performance management of the monitoring team, developing company-wide strategies, and collaborating cross-functionally. The ideal candidate possesses extensive clinical research experience, including leading monitoring departments, and a deep understanding of clinical monitoring and regulatory processes. This position requires up to 30% travel.

Requirements

• Possess a Bachelor's degree in a scientific or healthcare-related field
• Have at least 18 years of clinical research experience, including at least 5 years leading monitoring departments, coupled with demonstrated ability to grow and develop a department
• Have a minimum of 10 years line management experience
• Possess significant knowledge of pharmaceutical industry, drug development and regulatory processes
• Have a deep understanding of clinical monitoring and clinical oversight activities
• Possess strong project management skills with high sense of urgency, ability to collaborate and influence effectively cross-functionally
• Have a proven ability to effectively execute clinical trials within designated program budgets, timelines and compliance guidelines
• Possess excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Have experience working in a fast-paced and dynamic environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Responsibilities

• Provide leadership, strategic oversight, and guidance to the Apogee clinical monitoring team across all programs to ensure company objectives are met
• Be accountable for strategic CRA resource planning across the Apogee portfolio as well as the oversight of all CRA line management
• Be accountable for developing company-wide oversight monitoring strategies and framework to align with company goals and regulatory requirements and ensure consistency in oversight monitoring efforts across all programs and therapeutic areas
• Be responsible for the overall monitoring plans to ensure that third party vendors are monitoring according to Apogee expectations
• Collaborate cross-functionally to integrate oversight monitoring processes into the overall study operations
• Compile, assess, and communicate risks and optionality to support informed decision making for company monitoring strategy
• Serve as an escalation point for clinical monitoring issues with CRO partners and vendors
• Ensure that issues found during oversight visits are reported and actioned upon

Preferred Qualifications

Have biotech industry/start-up experience

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