Clinical Project Manager

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Zenas is a clinical‑stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy merges experienced leadership with a disciplined product candidate acquisition approach to identify, acquire and develop global product candidates that can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late‑stage, potential franchise molecules, obexelimab and orelabrutinib, and has early‑stage programs including a preclinical IL‑17AA/AF inhibitor and a preclinical TYK2 inhibitor.

The Clinical Project Manager is a member of the Zenas Clinical Operations team and is responsible for supporting the day‑to‑day operational management of one or more global clinical trials. Under the direction of the Clinical Project Lead, the CPM participates in a cross‑functional team to ensure alignment of activities with study projects and timelines. This position reports to the Senior Clinical Project Manager.

• Supports the management of operational aspects of one or more global clinical trials from start‑up to close‑out.
• Participates in planning and communication with cross‑functional teams within clinical development to ensure proper execution of clinical trials.
• Attends internal study team meetings and CRO/vendor meetings and follows up on outstanding issues assigned to him/her.
• May take on direct management of selected vendors under the supervision of the CPL.
• Reviews assigned vendor invoices and change orders and provides feedback to the CPL.
• Collaborates with Clinical Site Management on activities to meet study enrollment goals and timelines, including patient recruitment planning.
• Contributes to the development of clinical documentation including study protocols, informed consents, Study Reference Binder, study‑level plans and manuals, and training materials.
• Partners with Operational Excellence on e‑TMF compliance activities.
• Participates in the development and design of CRFs and CRF Completion Guidelines, including participation in the EDC and IRT specification process and UAT.
• May participate in departmental initiatives.

• B.A. or B.S. degree, preferably in a scientific discipline.
• A minimum of 5 years of industry experience in the pharmaceutical industry or equivalent, plus 1+ years of trial management experience.
• Solid understanding of the drug development process, ICH guidelines/GCP and specifically each step within the clinical trial process.
• Independently motivated, detail oriented and good problem‑solving ability. Ability to make independent, timely, and risk‑based decisions.
• Excellent written and verbal communication skills.
• Experience interacting with key functional stakeholders (clinical development, regulatory, QA, supply chain).
• Comfortable working in a demanding, fast‑paced, start‑up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.
• Demonstrates flexibility to work non‑traditional work hours when needed, given international operations across time zones.
• Ability to do some international travel (up to 25%).

The position is eligible for a competitive compensation and benefits package.

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $123,200 to $154,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.

Zenas Bio Pharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.