Senior Clinical Project Manager

Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody-drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next‑generation biologics from concept to clinic. Fortvita is a growing oncology‑focused pharmaceutical company, and is seeking an experienced Sr. Clinical Project Manager (SCPM) to oversee the planning, execution, and delivery of our oncology clinical trials across Phase I through III. As part of a small but high‑impact team, the SCPM will play a key role in driving operational excellence, managing internal or external monitoring teams of CROs and vendors, and ensuring clinical programs are delivered on time, within scope, and in compliance with GCP and regulatory standards. Responsibilities Independently lead the operational execution of oncology clinical trials from startup through close‑out. Serve as the primary point of contact for internal teams and external partners, including monitor teams, CROs, vendors, and clinical sites. Develop and maintain detailed project timelines, operational plans, budgets, and risk mitigation strategies. Support protocol development, informed consent forms, site feasibility assessments, and study document creation, review, update, and archive. Drive site engagement and issue resolution, collaborating closely with the Medical Monitor, Regulatory, Clinical Supply, Central Sample Management, and Data Management teams. Manage and oversee CROs and vendors, ensuring quality and performance against contractual obligations and timelines. Facilitate cross‑functional clinical study team meetings, ensuring documentation of decisions and follow‑up actions. Contribute to the development and continuous improvement of SOPs, tools, and operational best practices. Assist in preparation for regulatory inspections and submission of INDs/NDAs. Provide leadership in a hands‑on, resource‑limited environment, balancing strategic thinking with operational execution. Qualifications Bachelor’s degree in Life Sciences or related field required; advanced degree (MS, PharmD, PhD) a plus. 5+ years of clinical operations experience, with at least 3 years managing oncology trials. Experience in managing cross‑functional, global clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities. Demonstrated experience in vendor and CRO oversight, including contracts, budgets, and performance management. Strong understanding of FDA, EMA, ICH‑GCP guidelines, and clinical development processes. Effective leadership, communication, organizational, and interpersonal skills within small‑team environments. Ability to manage multiple projects and pivot quickly in a fast‑paced, evolving setting. Proficiency with CTMS, EDC systems, and Microsoft Office Suite. Self‑starter mindset with a collaborative spirit and willingness to “roll up your sleeves.” Compensation and Benefits Competitive base salary, bonus, and equity for all employees 401(k) retirement plan with employer matching contributions Comprehensive medical, dental, and vision insurance Generous paid time off policy, including company holidays and floating holidays Equal Opportunity Employer Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but is not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited. We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees. Legal Disclaimers Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire. Employment at Fortvita is at‑will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs. Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at View email address on click.appcast.io. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process. #J-18808-Ljbffr