Clinical Project Manager

Zenas BioPharma • Waltham, MA

17h • $123,200 - $154,000 • Hybrid

About The Position

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 combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation ! 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 combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation ! To learn more, please visit www.zenasbio.com Position Summary: 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. The CPM, under the direction of the Clinical Project Lead, (CPL) participates in a cross-functional team to ensure alignment of activities with study projects and timeline. This position reports to the Senior Clinical Project Manager.

Requirements

• 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%]

Responsibilities

• 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 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 but not limited to study protocols, informed consents, Study Reference Binder, study level plans and manuals and training materials.
• Partners with Operational Excellence on eTMF compliance activities.
• Participates in the development and design of CRFs and CRF Completion Guidelines, including participating in the EDC and IRT specification process and UAT.
• May participate in departmental initiatives.

Benefits

• The position is eligible for a competitive compensation and benefits package.
• Zenas is committed to fair and equitable compensation practices.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees