Director, Clinical Systems and TMF Operations

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row. A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists. Overview The Director, Clinical Systems and TMF Operations is a member of the Clinical Business Operations team within the Development Operations organization and is responsible to provide strategic leadership and oversight of Trial Master File (TMF) Operations, Records Management, and Clinical Systems & Technology (CST) utilized across clinical programs. This role will serve as the Business Owner for Clinical Systems and TMF Operations and has accountability to oversee the processes and staff within these areas to optimize the operating model, ensure ongoing inspection readiness, and foster a culture of continuous improvement. This role serves as a key leader and partner with internal cross-functional stakeholders and external suppliers to establish and uphold company standards and processes, achieve efficient set-up and implementation, and ensure oversight of systems and documentation across Insmed programs/trials, in compliance with SOPs, FDA regulations, GCP and ICH guidelines. This individual will evaluate evolving industry trends and best practices and assess their impact on current processes, formulate strategies, and lead the implementation of improvement initiatives to advance our business toward progressive ways of working. As a key change agent within the organization, this role will drive change management and promote adoption of enhanced processes, standards, and innovations. Responsibilities Clinical Systems & Technology: Provides leadership and expertise to build and deliver CST strategy and initiatives to support organizational business objectives. Develops business cases around clinical systems & technology, implements solutions, and measures effectiveness. Partners with cross-functional team members (e.g., Development Operations, Data Management, Tech Ops/Clin Supplies, QA, IT, Procurement) to identify and select CST supplier(s), and ensure effective onboarding and implementation (e.g., qualification, Computer System Validation (CSV), system specifications, UAT). Responsible for oversight of the CST vendors (e.g., IRT/RTSM, eCOA/ePRO) and ensuring both quality and timeliness of their work. Identifies areas of opportunity, mitigates risks, and provides solutions to identified problems. Oversees contracting and budget management activities including establishing initial Scope of Work (SOW) and Change Orders, as applicable. Ensures all QA CSV requirements are met to support system validation and vendor qualification according to Insmed requirements, and per study start-up timelines. Supports/Oversees kickoff meeting(s) for each respective trial with the system/technology supplier and internal cross-functional team members. As Business Owner, ensures processes, tools, documents, and training materials related to clinical systems and technology are developed and implemented, as appropriate. Acts as primary business change agent within Development Operations to ensure adoption of new capabilities and business processes related to clinical systems and technology. Serves as an escalation point for study teams to drive resolution of issues, as appropriate. Oversees staff and supports activities related to system builds and implementation, as needed (e.g., writing and/or executing UAT scripts). Ensures completion of system deliverables within established timelines. TMF Operations: Responsible for overall strategy and management of TMF Operations within the Global Clinical Development organization. Leads the strategic assessment, business case, and implementation of a fit-for-purpose TMF model and proposes modifications to meet evolving needs of the organization. Develops and implements innovative strategies to enhance TMF, records management, and other clinical trial documentation systems and processes, leverage technology, and ensure seamless operations. Ensures TMF compliance with industry standards and regulations. Oversees quality control activities to ensure TMFs are inspection ready. Establishes/enhances and oversees TMF metrics. Identifies trends and areas for improvement and implements support measures. Ensures processes, tools, documents, and training materials related to TMF and records management are developed and implemented, as appropriate. Provides functional support and expertise for audits and inspections. Creates/enhances standards for archiving and oversees activities to ensure adherence to processes and industry best practices. Line Management and Organizational Leadership: Provides functional leadership and strategic direction to the Clinical Systems and Documentation Management team, ensuring ongoing operational excellence. Evaluates industry changes and trends and proactively identifies and offers recommendations for organizational preparation/adoption of future capabilities related to trial technology and systems. Responsible for the management and leadership of direct reports including recruitment, training, mentoring, career development, work assignments, performance evaluations, and ongoing feedback. Partners with Head of Clinical Business Operations to forecast resource demand and perform capabilities assessments for CS&T and TMF Ops teams. Stays abreast of industry regulations and guidance updates/changes and provides relevant and timely training for the department. Builds and maintains collaborative business relationships with cross-functional partners as well as external vendors, ensuring expectations are clear, and deliverables met. Participates in partnership Governance committees, as appropriate. Position Requirements: Qualified candidates must have a Bachelor's degree from an accredited college or university; advanced degree is preferred. 10 years of progressive experience in a TMF and/or Systems Management role with a Sponsor/CRO company is required. Experience managing staff is required. Experience with Veeva Vault Clinical eTMF system is required. Experience managing IRT/RTSM and eCOA/ePRO systems is required. Experience authoring/reviewing procedures (SOPs, WIs) in a GCP environment is required. Experience in clinical trial conduct is a plus. Able to develop, execute, and evaluate strategies to improve process and set direction in the TMF and CST space. Keenly understands, identifies, and mitigates risks while ensuring communication of risks to the Head of Clinical Business Operations Effectively negotiates and influences to solve high impact challenges within the TMF and CST space. Strong leadership and project management skills, and is able demonstrate flexibility and agility working within a multi-functional, global matrix. Must have excellent communication skills (verbal and written), and good interpersonal/group skills. Individual must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace. Highly organized with a strong attention to detail, clarity, accuracy, and conciseness. Must successfully exhibit Insmed's five (5) core corporate values of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies. LI-MM1 Salary Range $179,000 - $250,800 a year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work, regionally based Competitive compensation package including bonus Stock options and RSU awards Employee Stock Purchase Plan (ESPP) Flexible Vacation Policy Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS: 401(k) plan with company match Medical, dental, and vision plans Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity insurance Employee Assistance Program (EAP) Mental Health on-line digital resource Well-being reimbursement Paid leave benefits for new parents Paid time off to volunteer On-site, no-cost fitness center at our U.S. headquarters Additional Information Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewardsinsmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Applications are accepted for 5 calendar days from the date posted or until the position is filled.