Senior Director, Clinical Operations

Company Overview:

Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Job Overview: 

The Senior Director, Clinical Operations (CO), will provide leadership and oversight for clinical trial activities, ensuring operational efficiency, meeting global regulatory standards, as well as contributing to the overall success of Protara’s clinical programs. They will collaborate with internal stakeholders, clinical research organizations (CROs), vendors, and external parties (i.e., clinical site staff), as needed, to ensure the timely and cost-effective completion of clinical trials. They will be responsible for ensuring clinical trials are in compliance with Protara’s procedures, FDA regulations, and other applicable global regulations, GCP and ICH requirements.  They will strive to meet or beat Protara’s annual Corporate goals within the specified timelines and budget, with an emphasis on quality.

*Location: New York City hybrid or remote.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Lead and mentor a team of CO professionals, fostering a culture of collaboration, accountability, and high performance.
• Drive process improvements, operational efficiencies, and risk management strategies within CO.
• Assess individual program needs in collaboration with VP, CO to ensure proper CO resourcing and budgeting across all Protara programs.
• Create and review CO Program timelines in Microsoft Project or SmartSheets.
• Work collaboratively with cross-functional teams (e.g., Clinical Science, Clinical Development, Program Management, Finance, Legal) to support clinical trial objectives.
• Lead the development of CO’s Standard Operating Procedures (SOP), Work Instructions (WI), training and other tools that will assist with onboarding new CO team members as well as inform current CO team on best practices.
• Provide feedback on relevant clinical documents (e.g., Protocols, Protocol Amendments, Informed Consent Forms (ICFs), Case Report Forms (CRFs), IRB/Ethics applications, recruitment materials, and other documents/plans, as applicable).
• Provide leadership in the development, implementation, and oversight of monitoring strategies for all Protara clinical trials.
• Ensure the integrity and quality of clinical trial data through periodic review of site’s data collection and performance.
• Perform or oversee co-monitoring visits to ensure the Clinical Research Organization’s (CRO) Clinical Research Associate’s (CRA) performance aligns with Protara’s expectations, ICH/GCP guidelines and the trial-specific monitoring plan.
• Assist with User Acceptance Testing (UAT) (e.g., MediData RAVE, eCOA, RTSM), as applicable.
• Provide clinical program updates, (e.g., trial status/metrics, budget, accomplishments and risks) to  VP, CO, Senior Management and other relevant stakeholders.
• Participate in the oversight of global Regulatory submissions and approvals to Competent Authorities (CAs) and Ethical Committees (ECs).
• Represent Protara externally to Investigators, site staff, Key Opinion Leaders (KOLs).
• Assist with inspection readiness activities that support regulatory audits and inspections related to clinical trial conduct.

Education and/or Experience:

• Bachelor's degree in a scientific or health-related field is required.
• Master's degree in a scientific or health-related field is preferred.
• Minimum of 10-15 years of experience in clinical operations, with at least 5 years in a senior leadership role.
• Demonstrated expertise in managing global clinical trials, from study design through regulatory submission and approval.
• Strong understanding of regulatory requirements and GCP guidelines.
• Proven track record of managing teams, vendors, and multi-disciplinary projects effectively.
• Experience in GCP inspections/audits required.

Supervisory Responsibilities:

• Associate Director and Clinical Tr