Senior Clinical Project Manager

Fortvita Biologics; United States; Teletrabalho; USD 120 000 - 180 000; Tempo integral

Resumo da oferta

Fortvita Biologics, a San Francisco Bay Area–based biopharmaceutical company, seeks a Sr. CPM to oversee oncology clinical trials (Phase I–III) with hands-on management and strategic oversight in a lean, high-impact team.

You will lead CROs and internal teams, ensuring trials meet GCP standards, with up to 50% travel and collaboration across globally dispersed sites. Remote work in the US is possible for candidates in select states.

Qualificações

• Bachelor's degree in Life Sciences required; advanced degree a plus.
• 5+ years of clinical operations experience, with 3+ years in oncology trials.
• Experience managing global, cross-functional clinical trials.
• Proven vendor/CRO oversight including contracts and budgets.
• Strong knowledge of FDA/EMA/ICH-GCP guidelines.
• Excellent leadership and cross-team communication.

Responsabilidades

• Lead operational execution of oncology trials from startup to close-out.
• Serve as primary contact for internal teams, CROs, vendors, and sites.
• Develop timelines, budgets, risk plans, and operational strategies.
• Support protocol development, ICFs, site feasibility, and study docs.
• Oversee CROs and vendors to ensure quality and timelines.
• Facilitate study team meetings and document decisions.

Conhecimentos

Clinical Operations

Oncology Trials

Vendor Oversight

CTMS

EDC

Regulatory Knowledge

Leadership

Cross-functional collaboration

Formação académica

Bachelor's degree in Life Sciences

Master's degree preferred

Ferramentas

CTMS

EDC systems

MS Office

Descrição da oferta de emprego

Remote - Hiring in these states: FL, NC, NJ, NY, PA, VA

Preference for FL & NC

Travel up to 50% required

ABOUT THE COMPANY

Fortvita Biologics is a San Francisco Bay Area-based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs. Building on our foundation in oncology, we are expanding into cardiovascular and metabolic diseases, immunology, and ophthalmology, applying our scientific rigor and platform capabilities to areas of growing global health burden. Our expertise covers antibody discovery and engineering, including monoclonal, bispecific, and polyspecific antibodies, as well as antibody-drug conjugates, all supported by development strategies rooted in thoughtful design and agile execution.

Our clinical development footprint covers the U.S., Australia, and key regions across APAC and Europe, including the EU, UK, South Korea, and Japan. With more than 100 professionals across research, development, regulatory, and operations, we bring deep expertise and a global perspective to every program. Guided by our mission to transform research breakthroughs into therapeutic excellence and driven by our vision to improve lives through scientific innovation, we are committed to delivering meaningful impact for patients around the world.

POSITION SUMMARY

The Sr. CPM will oversee the planning, execution, and delivery of our oncology clinical trials across Phase I through III upon the task assignment. This is a critical role that blends hands-on clinical trial management with strategic oversight in a highly collaborative, entrepreneurial environment. 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 team of CROs and vendors, and ensuring clinical programs are delivered on time, within scope, and in compliance with GCP and regulatory standards.

ESSENTIAL FUNCTIONS AND 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 team, 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/archive.
• Drive site engagement and issue resolution, collaborating closely with the Medical Monitor, Regulatory, Clinical Supply, Central Sample Management and Data Management team ect..
• Manage and oversee CROs and vendors, ensuring quality and performance against contractual obligations and timelines.
• Facilitate cross-functional clinical study team meetings, ensure 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.
• Other duties as assigned.

REQUIRED 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."

Competencies / Core Skills

• Communication
• Problem-solving
• Time management

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 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.

Additional 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 [e-mail]. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

Employment may be contingent upon successful completion of a background check and any other requirements permitted by law.