Associate Director, GxP R&D Systems

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

If this sounds like you, keep reading!

Role Summary

We are seeking an Associate Director, GxP R&D Systems to lead our efforts in supporting Quality, Regulatory, Clinical, Medical Affairs, and Biometrics teams. This role will focus on developing and maintaining an integrated system landscape for our GxP environment, ensuring seamless data flow and compliance across functions. You will be responsible for architecting solutions that support our clinical and regulatory operations and help advance our mission. The ideal candidate will be well-versed in GxP system architecture and integration, with a strong focus on data flow, system interoperability, and a deep understanding of GxP requirements.

Key Responsibilities

System Administration & Support:

• Administer and maintain GxP systems to ensure reliability, compliance, and data integrity.
• Monitor system performance and take proactive steps to address potential issues.
• Troubleshoot system issues and work with vendors for timely resolution.
• Ensure that system configurations are aligned with business and compliance requirements.

Solution Design and Implementation

• Design and implement solutions to support Quality, Regulatory, Clinical, Medical Affairs, and Biometrics teams.
• Architect and maintain the integration of R&D and GxP systems, identifying and addressing gaps in the current system landscape.
• Provide technical guidance and expertise throughout the lifecycle of system implementations and enhancements.

Integration Leadership

• Lead integration efforts across GxP systems using tools like middleware integration platforms.
• Ensure data flows seamlessly between systems, leveraging the latest features and updates.
• Collaborate with external vendors and implementation partners to optimize system functionality.
• Evaluate and implement integration solutions that enhance scalability and efficiency as the company expands.

 Compliance and Data Governance

• Ensure data integrity, security, and compliance for all R&D systems.
• Implement best practices for data governance and ensure that all systems meet GxP compliance requirements.
• Provide regular training and support to system users to maintain compliance and efficient use of the systems.
• Develop and maintain documentation to support regulatory audits and inspections.

 Team Collaboration and Leadership

• Foster a collaborative and high-performing IT team, providing mentorship, guidance, and opportunities for professional growth.
• Instill a culture of continuous improvement and innovation within the IT department.
• Lead efforts to provide regular training and support to system users, ensuring efficient use of GxP systems.
• Build strong cross-functional relationships to ensure IT alignment with business needs during scaling initiatives.

Ideal Candidate

• 8+ years of experience in systems architecture, integration, or similar roles in a biotech or pharmaceutical environment.
• Expertise in GxP system integration, including hands-on experience with middleware integration tools (e.g., Mulesoft).
• Experience with clinical, quality, and regulatory systems (e.g., eTMF, QMS, Regulatory Submissions) in a GxP environment.
• Strong understanding of GxP requirements, data integrity, and compliance.
• Proven ability to manage multiple complex projects and work effectively with both technical and non-technical stakeholders.
• Strong leadership skills with a growth mindset, dedicated to fostering a psychologically safe and innovative work environment.
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability to travel appropriately 10 – 15%

#LI-JY1

The anticipated salary range for candidates for this role will be $165,000-$200,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

What We Offer

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

To review our privacy policy, click here