Join Our Mission to Transform Cancer Treatment as a Sr. TMF Manager!

Imagine playing a pivotal role in bringing life-changing cancer therapies to patients across the globe. As a Sr. TMF Manager, you won't just be organizing documents; you'll be the strategic architect ensuring every piece of our clinical trial data is meticulously managed, compliant, and ready to make an impact. MacroGenics invites a seasoned TMF expert to lead our efforts from anywhere in the world, becoming a crucial part of our dedicated team advancing innovative medicines.

Overview

MacroGenics stands at the forefront of medical innovation, specializing in the discovery and development of next-generation antibody-based technologies. Our passionate team of over 150 individuals is committed to advancing a robust pipeline of product candidates aimed at treating patients with cancer. Our groundbreaking products and platforms have attracted strong partnerships with leading pharmaceutical and biotechnology companies globally. We truly believe our employees are our most valuable asset, fostering an environment where individuals can grow professionally and see their direct contribution to our shared success. This position provides critical TMF expertise, leading a cross-functional team in all aspects of managing the trial master file, from initial setup to comprehensive oversight. You will manage timelines and deliverables while maintaining the highest standards of quality and regulatory compliance. This is a fully remote opportunity, open to talented professionals worldwide.

Key Responsibilities

Lead the strategic planning, setup, design, and ongoing oversight of Trial Master Files (TMFs) across all clinical programs.
Drive efficient management of TMF timelines, ensuring all deliverables are met with precision and quality.
Serve as the primary TMF subject matter expert, providing guidance and support to cross-functional teams including Clinical Operations, Regulatory Affairs, and Quality Assurance.
Ensure the TMF is consistently maintained in an audit-ready state, adhering strictly to ICH GCP guidelines, regulatory requirements, and company standard operating procedures.
Cultivate strong collaborative relationships with internal teams and external partners, fostering open communication and seamless information exchange.
Develop and implement TMF best practices, processes, and tools to enhance efficiency and compliance.
Conduct regular quality control reviews and audits of TMF documents, identifying and resolving any discrepancies proactively.
Oversee the archiving process for TMFs, ensuring compliance with all applicable regulations.
Participate in regulatory inspections and internal audits, providing expert support and documentation.

Requirements

Bachelor's degree in a life science, health-related field, or equivalent practical experience.
At least 5 years of progressive experience in Trial Master File management within the biotechnology or pharmaceutical industry.
Demonstrated leadership experience, including leading cross-functional teams or TMF projects.
Deep expertise in ICH GCP guidelines, regulatory requirements for clinical trials, and TMF reference models (e.g., TMF Reference Model).
Proven ability to manage multiple projects simultaneously, prioritize tasks effectively, and meet tight deadlines.
Exceptional organizational skills and meticulous attention to detail.
Strong interpersonal and communication skills, capable of building effective relationships across diverse teams and cultures.
Proficiency with electronic TMF (eTMF) systems and other relevant clinical trial management software.
Ability to work independently and collaboratively in a remote work environment.

What You'll Gain

An opportunity to make a tangible impact on the lives of cancer patients through your expertise in TMF management.
Be part of a dynamic, innovative company culture that values open communication, teamwork, and employee growth.
Engage in challenging and rewarding work within a supportive and collaborative global remote team.
Access to professional development opportunities to further your career in clinical operations and regulatory compliance.
The flexibility and autonomy of a fully remote position, allowing you to contribute from anywhere in the world.