Associate Director, Clinical Business Operations

Zenas BioPharma•Waltham, MA

14h•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 ! Position Summary: We are seeking a highly motivated and experienced professional for Zenas BioPharma as a Clinical Business Operations Associate Director (CBO AD). The CBO AD will partner with Finance/Strategic Sourcing to plan and execute critical business transactions and activities. These activities Include, but are not limited to, coordinating end-to-end vendor selection and outsourcing activities, clinical site contracting, ongoing financial reviews with FP&A, and ensuring compliance of contractual agreements with the Legal Department. The role will contribute directly to managing departmental business operations and ad-hoc operational projects by providing project management support for designated project workstreams. The successful candidate will be responsible for collaborating with departmental SMEs to provide expertise in Clinical Operations requirements and understanding of clinical business systems. This role reports to the Senior Director of Clinical Business Operations.

Requirements

Bachelor's degree in business, scientific or healthcare-related discipline.
Minimum 8+ years of experience in clinical development operations or clinical vendor management, site contracting or related pharmaceutical or biotechnology industry roles.
Solid understanding of clinical trial operations, procedures, and industry regulations (e.g., ICH-GCP, FDA, EU, APAC, LATAM guidelines).
Proven record of accomplishment in building and maintaining strong relationships with internal stakeholders, business partners, and CROs/outsourced partners.
Demonstrated ability to influence without authority and effectively negotiate at various organizational levels.
Excellent project management skills, including managing multiple priorities, stakeholders, and deliverables simultaneously.
Strong analytical and problem-solving skills, with a commitment to data-driven, risk-based decision-making.
Exceptional communication and presentation skills, both written and verbal, can convey complex information clearly and concisely.
High adaptability, resilience, and flexibility in a dynamic, fast-paced work environment.

Nice To Haves

Experience with global Ph2 / Ph3 clinical trials preferred.

Responsibilities

Study-level responsibilities Lead the development and revision of protocol-specific budget templates utilized in Clinical Trial Agreement (CTA) negotiations with sites.
Assist in the development of protocol-specific global and country-level CTA templates and global and country-level Informed Consent Form templates.
Serve as first-line point of escalation for Non-disclosure Agreements, Clinical Trial Agreements and amendments, budgets, and Informed Consent Forms that deviate from Zenas templated language and terms.
Ensure that Zenas’s Fair-Market Value (FMV) standards are maintained for site contracts by CROs.
Review and approve study-level vendor contract amendments, ensuring that budget modifications are accurate, appropriate, and aligned with Zenas business needs and priorities.
Ensure that appropriate communication and alignment occurs between Study Team members and Finance.
Liaise with Study Team members and Finance, Legal, and Compliance to solve dynamic problems and ensure smooth and efficient study execution.
Develop and maintain study-level budgets and forecasts, liaising with Clinical Operations functions, vendors, and Zenas Finance.
Work closely with Clinical Operations functional leads and Finance to manage the overall study budget.
Vendor Contracting and Oversight Responsibilities Manage the contract lifecycle (i.e., drafting, negotiating, executing, tracking, archiving) of vendor agreements and site contracts including effective negotiation of budget and payment terms.
Identify business issues in negotiations and advise team to enable appropriate judgement calls on such issues.
Support Clinical Operations and broader Clinical vendor outsourcing lifecycle management, including Request-for-Information (RFI) and Request-for-Proposal (RFP) activities for development services such as study management (CRO services), central laboratory, bioanalytical services, interactive response technology (IRT), etc.
Develop and maintain strategic partnerships with key vendors to enable effective collaboration, issue resolution and a governance framework.
Serve as an escalation point for vendor performance issues, as needed.
General Clinical Business Operations Responsibilities Provide project management support for designated workstreams to help achieve department goals and long-term goals, strategies, and vision.
Coordinate requirements creation, implementation plans, and provide oversight on the implementation and maintenance for key Clinical Operations systems and business processes.
Responsible as a point of contact for business operational initiatives and ensure representation for Clinical Operations in cross-R&D initiatives (e.g., data privacy, archival, IT system implementations).
Collaborate with SMEs for scope definition and Finance for budget review and negotiation to complete projects successfully, on-time, and on-budget.
Provide input to and participate in monthly and quarterly financial reviews of Clinical Operations expenses.
Understand clinical business systems and capabilities for Clinical Operations, with a focus on flexible site engagement and clinical trial management systems (CTMS).
Develop departmental SOPs, work instructions, and training tools in support of the activities listed above.
Stay up to date with industry trends and best practices in the utilization of clinical development operations business systems.