Global Clinical Project Manager - Orelabrutinib (BTK)

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 ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcγRIIb monoclonal antibody. 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 ! 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 two global Phase III clinical trials, with specific emphasis on vendor management. The CPM, working closely with the Clinical Operations Global Project Leads (COPL), participates in a cross-functional team to ensure alignment of activities with study projects and timeline. This position reports to the Senior Director, Clinical Project Management / Orelabrutinib. Key Responsibilities Direct oversight of clinical vendors contracted directly by Zenas. Vendors include the central laboratory and central MRI imaging reader. Additional vendors may be included. Support vendor contract and budget negotiations, review budgets, and change orders. Review assigned vendor invoices and change orders and provide feedback to the COPL. Review and approve vendor’s Project Plans, manuals, and associated documents. Attends internal study team meetings and CRO/vendor meetings and follows up on outstanding issues assigned to him/her. Participate 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. Additional activities may be assigned to support the management of the Phase III trials. Qualifications B.A. or B.S. degree, preferably in a scientific discipline. A minimum of 3-5 years of industry experience in the pharmaceutical industry or equivalent, plus 1+ years of vendor 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. Willingness to come into the office a minimum of 2 days/week. 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 $120,000 to $150,000. 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 BioPharma 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. #J-18808-Ljbffr