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Sr. Clinical Compliance Manager, Clinical Operations

Remote

 

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.”
We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. 
If this sounds like you, keep reading!

 

Role Summary

We are seeking a Sr. Clinical Compliance Manager.  This role will operate as the liaison between Clinical Operations, Quality Assurance and external vendors. In this newly created role, you will support the day-to-day Clinical Operations compliance and inspection readiness strategy and serve as a key team member and subject-matter-expert (SME) in the planning and execution of trial-specific training, SOP management, compliance checks, and inspection readiness.  You will also establish concepts, best practices, and processes in support of operational excellence and inspection readiness for Clinical Operations.  Additionally, you may support corrective action initiatives across programs towards the goal of building and managing a culture of quality while maximizing compliance. 

Key Responsibilities

Clinical Compliance

  • 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

Support in SOP Development and Management

  • 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

Training and Learning Management System Platform

  • 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

Inspection Readiness:

  • 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

Ideal Candidate

  • Must have a bachelor's degree and relevant professional experience
  • Minimum10 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: Caring, Original, Resilient and Egoless
  • Position requires up to 30% travel - including 2 All Hands Meetings plus functional meetings

The anticipated salary range for candidates for this role will be $135,000 - $165,000/year. 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
  • A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
  • 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
 
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
 
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

 

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