Job description
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
The Manager of Clinical Systems serves as the clinical systems manager. This position is responsible for the oversight, planning, and execution of end-to-end clinical system processes from start up through archival. This position will provide technical and business administration in support of system compliance, and inspection readiness. This position will require cross-functional collaboration to drive change management, promote adoption of processes and standards enhancements, foster a culture of continuous improvement, and ensure proper implementation, execution, and alignment with companies’ goals, culture, and vision. This position will assist with developing and implementing clinical system processes within the system and particularly as they apply to the SOPs, supporting tools, templates, and training. This position will collaborate with vendors and work with the IT group to support system implementation, maintenance, and configuration changes of the clinical systems in alignment with the business requirements.
Key Responsibilities
- Provide clinical system guidance as a Subject Matter Expert (SME) for clinical system operations and requirements across study team functions, CROs, and vendors.
- Fulfill administrative role within Veeva Vault Clinical, (i.e., Business Administrator and/or System Administrator.), serve as a clinical systems escalation point for stakeholders, drive resolution of issues, as appropriate.
- Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner.
- Ensure compliance with clinical system SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available), applicable regulations, GCP requirements, and industry standards.
- Generate and report KPIs, metrics and analytics, identifying trends across the clinical systems portfolio, areas for improvement, and implementing changes as needed.
- Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required.
- Lead and support development and implementation of processes, procedures, supporting tools, and related training materials that adhere to regulatory requirements and industry best practices.
- Oversee end-to-end clinical system management to ensure adherence to processes, to meet the goals and objectives of the department, and maintain inspection readiness for all studies.
- Support archiving activities to ensure adherence to processes and industry best practices.
- Collaborate on projects with Information Technology (IT), Quality Assurance and Clinical System Validation teams to ensure effective implementation and integration of clinical systems, implement system releases, updates, bug fixes and/ or enhancements.
- Create and provide clinical system training, Act as a primary support role for clinical system users and stakeholders.
- Executes change management activities to ensure consistent application of revised standards, processes, and systems functionality including validation.
Ideal Candidate
- Bachelor’s Degree or higher or equivalent experience.
- At least 5-8 years of experience successfully managing clinical system activities for clinical research/ biotech/pharmaceutical.
- Veeva Vault platform experience in the eTMF, CTMS and LMS vaults preferred.
- Experience with implementation and integration of clinical systems and writing and revising SOPs related to clinical systems.
- Experience with computer system validation/assurance process.
- Experience in managing teams in the successful execution of projects, knowledge of the principles and practices of traditional records management as applied to the pharmaceutical/ biotech or contract research organization industry.
- Comprehensive knowledge of TMF Reference Model, regulations, Good Clinical Practices (GCP), and ICH Guidelines.
- Strong software and computer skills, including Microsoft Office applications (Outlook, Word, Excel & PowerPoint).
- Knowledge of relevant licensing and industry compliance regulations.
- Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless.
- Demonstrated effective written and verbal communication skills with internal and external team members, and functional leadership.
- Able to lead initiatives and communicate effectively through presentations for external and internal audiences.
- Excellent organizational skills with outstanding attention to detail and follow-through.
- Able to work independently and to function as a team player.
- Able to navigate complex problems, develop advanced concepts, make decisions, anticipate challenges, and propose solutions/recommendations.
The anticipated salary range for candidates for this role will be $145,000-$165,000. 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
- 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.
A pogee 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.
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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
