Senior Clinical Project Manager: Orelabrutinib

Zenas BioPharma•Waltham, MA

2d•$149,300 - $186,630•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!

Requirements

B.A. or B.S. degree, preferably in a scientific discipline
A minimum of 7 years of industry experience in the pharmaceutical industry or equivalent, plus 4+ years of trial management experience managing study teams for phase II or III studies.
Multi-country global study experience is required.
Prior experience in management of CROs
Experience with clinical study budgets,
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.
Strong leadership and decision making 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.
Flexibility to work non-traditional work hours when needed, given international operations across time zones.
Ability to travel [up to 25%]

Responsibilities

Manage all operational aspects of a global clinical trial from start-up to close-out; proactively identifying and resolving operational issues to assure adherence to timelines, budget and milestones while ensuring compliance to applicable SOPs, guidelines, and regulations.
Participate in planning and communication with cross functional teams within clinical development to ensure proper execution of clinical trials.
Chair internal Study Team Meetings.
Participate in evaluation and selection of clinical study vendors including CRO, Central labs, Imaging, ePRO, etc.
Manage and provide day-to-day oversight of CROs and third-party vendors including set-up, logistics, documentation, and clinical supplies needed for clinical trial(s)
Responsible for the trial level clinical operations budget, invoices, and change orders.
Work with Clinical Business Operations team on study budget forecast and monthly accruals.
Collaborate with the Zenas Site Relationship Manager on activities to meet study enrollment goals and timelines.
Develop and maintain study timelines, enrollment dashboards and status reports for senior management.
In collaboration with Regulatory Affairs and Site Relationship Manager, respond to RFIs from Regulatory Authorities, IRBs and Ethics Committees, ensuring responses are submitted within the required timeframe.
Contribute to the development of clinical documentation including but not limited to study protocols, informed consents, study level plans and manuals and training materials.
Participates in the development and design of CRFs and CRF Completion Guidelines, including participating in the EDC and IRT specification process and UAT.
May assist with the development of any new or updated SOPs/processes for the clinical department.
May train, mentor and manage junior team members.
May participate in departmental initiatives