Director, Clinical Operations

BioSpace; New York (NY); On-site; USD 220,000 - 225,000; Full time

Benefits offered by this job

Competitive salary

Unlimited PTO

Flexible working hours

Comprehensive health benefits

Job summary

A clinical-stage biotechnology company is seeking a Director of Clinical Operations to oversee clinical trial activities, ensuring compliance with regulations and operational efficiency. The successful candidate will lead a team, drive process improvements, and manage global clinical trials in alignment with corporate goals. Exceptional teamwork and strong analytical skills are essential. Offering a competitive salary package of $220,000 - $225,000 plus benefits like unlimited PTO and flexible working hours.

Qualifications

• 5-10 years of experience in clinical operations with leadership role.
• 5+ years of experience specifically in Non-Muscle Invasive Bladder Cancer.
• Demonstrated expertise in managing global clinical trials.

Responsibilities

• Lead and mentor Clinical Operations team to success.
• Drive process improvements and operational efficiencies.
• Ensure clinical trials comply with internal and regulatory standards.

Skills

Team leadership

Operational efficiency

Risk management

Regulatory compliance

Analytical skills

Education

Bachelor's degree in a scientific or health-related field

Master's degree in a scientific or health-related field

Tools

Microsoft Office Suite

Smartsheet

Job description

Company Overview

Protara Therapeutics 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 Director, Clinical Operations (CO) provides leadership and oversight for clinical trial activities, ensuring operational efficiency and compliance with global regulatory standards. The role collaborates with internal stakeholders, CROs, vendors, and site staff to complete clinical trials in a timely and cost‑effective manner, while focusing on quality, budget, and timeline goals.

Essential Duties and Responsibilities

• 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 Smartsheet.
• 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 (KOL).
• 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 5‑10 years of experience in clinical operations, with at least 5 years in a leadership role.
• Minimum of 5+ years NMIBC experience required.
• 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

• Clinical Trial Manager roles will be reporting into this position.

Computer Skills

• Proficient in Microsoft (MS) Office Suite (e.g., Word, Excel, PowerPoint, Project).
• Experience with Smartsheet is preferred.

Certificates, Licenses, Registrations

• PMP certification preferred.

Other Skills and Abilities

• Strong ability to prioritize tasks with keen attention to detail.
• Strong organizational, analytical, problem‑solving, and communication skills.
• Must be a dependable self‑starter and capable of working independently on multiple projects with the ability to prioritize tasks and meet deadlines.
• Thrives in a small biotech, fast‑paced environment and enjoys working on multiple projects simultaneously.
• Strong interpersonal skills with the ability to interact effectively with all levels of Senior Management, both internal and external to the organization.

Physical Demands

Minimal travel is required; average travel 10‑15%, including meetings, conferences, and site visits as needed.

Work Environment

Stable internet access is required. Salary range $220,000–$225,000 based on experience and qualifications. Compensation and benefits include incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.

Equal Opportunity Employer

Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws.