Senior Director, Clinical Operations

Fortitude Biomedicines is a private biotechnology company headquartered in Waltham, Massachusetts, focused on next‑generation immune cell targeting biologics and an antibody–drug conjugate (ADC) platform powered by proprietary molecular glue payloads. The company is dedicated to delivering meaningful benefits to patients with serious autoimmune and oncology conditions and high unmet medical need, offering team members the opportunity to contribute to innovative, impact‑driven science. Role Description The Senior Director, Clinical Operations, will serve a key leadership role for oversight and conduct of Clinical Operations activities, within the Clinical Development team. Senior Director, Clinical Operations is a full‑time, hybrid role based in Waltham, MA. This position is responsible for leading the planning, execution, and oversight of global clinical trials across Fortitude’s portfolio. This role also provides strategic leadership to the Clinical Operations team, including mentoring and managing other Clin Ops team members, establishing best practices, and contributing to long‑term portfolio and resource planning. Key Responsibilities and Expectations include the following Serve as the key leader and point of contact for management of Clinical Operations activities, within the Clinical Development team. Ensure oversight of clinical operations activities, within clinical development team and program, to ensure project milestones and deliverables are on track, in particular with respect to timelines and budget. Manage clinical trials both domestically and internationally via CROs and clinical vendors, including providing key Sponsor oversight and leadership of CRO activities. Complete internal and external clinical program documentation and reporting. Identify, measure, and report on clinical program benchmark key performance indicators (KPIs), milestones, and deliverables, such as clinical synopsis and protocol (and amendments) development and finalization, CRO contracting, study enrollment activities, database lock, report finalization. Meaningfully contribute to the planning and implementation of clinical development programs, with specific focus on clinical operations activities, including scenario planning, timeline forecasting, program level feasibility assessments, estimation of resources and budget, and development of operational strategies, as well as leading key team meetings for Clinical Operations function. Ensure clinical programs adhere to applicable regulations and guidelines. Collaborate cross functionally with key team members in Clinical Development and Research teams, especially Medical Lead, Regulatory, Data Management, and Quality to ensure smooth launch and conduct of clinical studies. Supervise and lead direct reports within Clinical Operations, such as Clinical Trial Managers, and Sponsor CRAs. Flexible and Adaptable mindset to work in a small organization setting, where a variety of other duties may come up in a lean organization structure, as part of a dynamic, small biotech team. Qualifications BA/BS degree in related field required. RN/PA with professional clinical experience, and/or master’s degree or higher in health‑related science or equivalent preferred. 8+ years of relevant Clinical Operations leadership experience. Early stage biotech clinical trial experience and leadership preferred. Experience in autoimmune/inflammatory disease therapeutic indications, as well as with biologic therapies. Depth of knowledge and experience managing Phase 1-3 pharmaceutical/biotech clinical trials both domestically and internationally via CROs and direct study management, as well as strong familiarity with regulations, in particular ICH/GCP guidelines. Demonstrated leadership skills related to managing directly, in a cross‑functional matrix setting and interdepartmentally. Strong track record of management success on complex studies and programs. Ability to lead, align with, and inspire cross‑functional Sponsor team towards successful attainment of goals. Excellent interpersonal skills and ability to act with integrity and professionalism to ensure that all business is conducted without bias or prejudice. Composure, positivity, flexibility, and time management ability necessary to succeed in a performance‑driven, small and dynamic biotech environment. Exceptional leadership, communication, operational, problem‑solving, organizational and planning skills. Ability to handle uncertainties and challenges that may arise in clinical trials, with ability to analyze problems, reach executive decisions collaboratively, with appropriate problem solving skills and fund of experiential knowledge. Ability to work well independently and without close supervision, keeping focused on short- and long‑term objectives, while also working collaboratively within a lean organization. Demonstrating attention to detail and planing and prioritizing workload with competing priorities. Ability to follow directions and meet deadlines. Ability to handle confidential and sensitive information. Ability to present and convey Clinical Operational status and updates to Executive Leadership team, with ability to anticipate and mitigate risks and challenges that may arise in a development program. Strong mastery of key software for documents, such as Word, Excel, PowerPoint, as well as familiarity with key clinical trials software platforms used in trial operations. Fortitude Biomedicines is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. #J-18808-Ljbffr Fortitude Biomedicines