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 Senior Director of TMF to serve as the Head of Trial Master File (TMF) Operations. This position is responsible for the oversight, creation, strategy, planning, resourcing, and execution of a TMF document management system for the clinical operations department. This position is responsible for cross-functional collaboration to ensure proper implementation, execution and alignment with companies’ goals, culture, and vision. This role is accountable to develop document collection strategies and develop SOPs, training, and overall process to ensure the TMF health and archival of clinical trial documents from both external and internal sources. The position is responsible for direct reports to manage the TMF and continue to work with IT in the evaluation, and implementation of any additional technology and vendors to support documentation and training solutions for inspection readiness.
Key Responsibilities
Provide leadership and strategic direction across Clinical Operations and study team functions to ensure the Trial Master File (TMF) processes and related documentations are of the highest quality for active in-house and outsourced studies by drawing experience w/ quality compliance processes and regulations such as Good Clinical & Documentation Practices
Adhere to ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available)
Develop standard reporting for ongoing compliance check by study to be presented at the Clinical study team meetings and to management
Lead a team of direct reports that will support the TMF platforms and each study TMF
Author and review internal and external TMF-related SOPs, work instruction development and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes etc.) including working with the cross functional study team to obtain necessary input
Manage the TMF processes to meet the goals and objectives of the department and maintains inspection readiness for all active studies
Create and lead training across all relevant business units/functional areas on business processes around Clinical Document Management and the Trial Master File, eTMF system(s), and quality oversight of vendors
Development and oversight of management and maintenance of TMF repositories, including supporting filing, scanning, QC, and inventory of paper documents
Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management
Support study teams in end of trial eTMF QC and migration activities, including study documents from all vendors
Drive the development and reporting of metrics and KPIs related to inspection readiness, quality, TMF completeness, and performance
Ad hoc support of activities within the Clinical Operations team to help meet timelines and objectives including support with archiving, document collection and processing, and/or start-up activities as needed
Apply knowledge of ICH-GCP, Code of Federal Regulations (CFR), and other national and local requirements to develop and improve document management processes
Ideal Candidate
Bachelor's Degree or higher
15+ years' experience leading successfully the TMF activities for clinical research/ biotech/pharmaceutical
Leadership skills and experience managing employees and contractors
Experience with Veeva eTMF platform, strongly preferred
Experience with Trial Master File Reference model and good understanding of records management best practices
Knowledge of applicable TMF and Document Management regulations and guidelines such as CFR Part 11, MHRA and EMA
Experience with Inspection readiness
Hands on experience in a regulatory body inspection, strongly preferred
Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process
BEHAVIORAL COMPETENCIES
Excellent attention to accuracy and details
Effective written and verbal communication skills
Excellent presentation skills, providing information to a large audience
Strong software and computer skills, including Microsoft Office applications (Word, Excel, Outlook)
Outstanding organizational skills with the ability to multi-task and prioritize in a fast-paced environment
Ability to learn new technologies with ease
Solid analytical and proactive problem-solving skills
Strong operational skills and demonstrated ability to meet timelines
A team player with ability to build relationships at all levels
Demonstrated self-starter with a high level of commitment
The anticipated salary range for candidates for this role will be $ 250,000-$280,000/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 .
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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Seniority level
Director
Employment type
Full-time
Job function
Other
Industries
Biotechnology Research
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