Senior Clinical Compliance Manager

Summary

Join Apogee Therapeutics as a Sr. Clinical Compliance Manager and act as a liaison between Clinical Operations, Quality Assurance, and external vendors. This newly created role supports daily Clinical Operations compliance and inspection readiness. You will be a key team member and subject-matter-expert (SME) in planning and executing trial-specific training, SOP management, compliance checks, and inspection readiness. You will establish concepts, best practices, and processes to support operational excellence and inspection readiness. The role also involves supporting corrective action initiatives and building a culture of quality. This position requires a bachelor's degree, 10+ years of relevant experience, and in-depth knowledge of regulatory guidelines. Apogee offers a competitive compensation and benefits package, including flexible PTO and company-wide shutdowns.

Requirements

• Must have a bachelor's degree and relevant professional experience
• Minimum 10 years of relevant and progressive clinical trial management experience
• In-depth knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations
• Knowledge of the principles and practices of SOP management as applied to the pharmaceutical/biotech or contract research organization industry
• Strong leadership and management skills; working in a fast-paced, high accountability environment with minimal oversight and the incorporation of multiple points of views
• Self-direction, motivation, problem solving and decision-making abilities
• Experience in full-cycle drug development, including mock and regulatory inspection activities
• Ability to work effectively in a collaborative team environment where results are achieved through influence and cooperation
• Highly organized, with a strong attention to detail, clarity, accuracy, and conciseness
• Able to communicate effectively through presentations for external and internal audiences
• Successfully exhibit Apogee’s C.O.R.E. values: C aring, O riginal, R esilient and E goless

Responsibilities

• Ensure the team is building successful compliance related processes, enabling and allowing seamless execution as Apogee grows our pipeline of clinical studies
• Assess/ensure proper documentation of any Clinical Operations process deviations
• Collaborate with Process Excellence Head to manage trial specific training curriculum
• Provide guidance on inspection readiness activities for Clinical Operations
• Ensure teams are adhering to company’s processes
• May write and support in SOP development
• Support in maintaining a list of SOPs and tracking expiration dates in conjunction with QA
• May perform (or oversee) trial compliance checks to ensure teams are adhering to Apogee’s SOPs and processes, CRO SOPs (if applicable), and trial specific plans (e.g., Monitoring Plan, Vendor Oversight Plan, TMF Plan, etc.)
• May contribute to the development/management of clinical SOPs and cross-functional processes and lead or participate in implementation of initiatives
• May create and oversee the cross-functional role-based training matrix and monthly compliance
• May administer the LMS, including user access control, assigning courses to appropriate staff, tracking course completion, and generating reports on training progress and compliance
• Oversee the process for project specific training, vendors and templates
• Manage and facilitate study and departmental training of new Clinical Operations team members onboarding slide deck
• Support in inspection readiness exercises with team
• May support in the management of CAPAs for the Clinical Operations team
• Ensure effective preparations for regulatory inspections
• Partner with Process Excellence Head to successfully manage core inspection readiness activities; ensures compliance team is aligned with activities
• May collaborate with Process Excellence Head and Quality Assurance on the planning and conducting of internal audits and mock inspection(s)
• Work with the clinical trial teams to identify operational issues/processes and opportunities for improvement to ensure achievement of study milestones, data quality and data integrity
• Co-lead or lead strategic initiatives, either autonomously or collaboratively, which target continuous improvement and achievement of operational excellence to support inspection readiness

Preferred Qualifications

Position requires up to 30% travel - including 2 All Hands Meetings plus functional meetings

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