Associate Clinical Project Manager
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 ! Position Summary: The Associate Clinical Project Manager is a member of the Zenas Clinical Operations team and is responsible for assisting with the day-to-day operational management of one or more global clinical trials and oversight of CROs and clinical vendors. The ACPM participates in a cross-functional team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timeline. This position reports to the Associate Director, Clinical Program Management.
Requirements
- B.A. or B.S. degree, preferably in a scientific discipline
- A minimum of 2-3 year industry experience in the pharmaceutical industry or equivalent, plus 2+ years of trial management experience managing study teams for phase I, 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.
- Excellent attention to detail and follow-up
- 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 20%]
Responsibilities
- Assist with the operational aspects of multiple global clinical trials from start-up to close-out; proactively identifies and resolves operational issues to assure adherence to timelines, budget and/or milestones while ensuring compliance to applicable SOPs, guidelines, and regulations.
- Participates in planning and communication with cross functional teams within clinical development to ensure proper execution of clinical trials.
- Participates in evaluation and selection of clinical study vendors including CRO, Data Management, IRT, Central labs, Imaging, etc.
- Help to provide day-to-day oversight of CROs and third-party vendors including set-up, logistics, documentation, and clinical supplies needed for clinical trial(s)
- Assist with trial level clinical operations budget, invoices, and change orders.
- Participates in patient recruitment planning collaborates with Clinical Site Management on activities to meet study enrollment goals and timelines.
- Maintains study timelines, enrollment dashboards and status reports for senior management and reports on issues as required.
- 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.
- Participates in the development and design of CRFs and CRF Completion Guidelines, including participating in the EDC and IXRS specification process and UAT.
- Contributes to and may lead the development of presentations for clinical sites, team and investigator meetings.
- Participates in evaluation and selection of clinical study vendors including CRO, IRT, Central labs, Imaging, etc.
- May assist with the development of any new or updated SOPs/processes for the clinical department.
- Assists with the maintenance of the Trial Master File
- May participate in departmental initiatives
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
