Senior Director, Clinical Operations

The Senior Director, Clinical Operations provides strategic and operational leadership for the planning, execution, and oversight of oncology clinical trials across the company’s development portfolio. This role is accountable for end-to-end clinical operations delivery, ensuring studies are conducted efficiently, compliantly, and in alignment with corporate timelines and objectives. This individual partners closely with Clinical/Medical Development, Regulatory Affairs, Pharmacovigilance, and external vendors to drive high-quality execution of complex oncology trials, including early- and late-phase programs. The Senior Director plays a critical role in building scalable clinical operations infrastructure, mentoring teams, and representing Clinical Operations to executive leadership. 

Principal Duties and Responsibilities:

• Provide strategic leadership for the clinical operations function across multiple oncology programs and phases
• Develop and execute clinical operations strategy aligned with overall development and corporate goals
• Oversee the operational delivery of the clinical trial portfolio, ensuring adherence to timelines, budgets, and quality standards
• Identify and proactively manage cross-program risks, dependencies, and resource constraints
• Provide regular portfolio-level updates to Head of Clinical Operations
• Ensure successful end-to-end execution of oncology clinical trials, including study planning and feasibility, start-up and site activation, enrollment and retention, trial conduct and close-out
• Provide senior oversight and guidance to Clinical Trial Managers and Directors
• Ensure operational feasibility is incorporated into protocol design and development plans
• Support execution of complex oncology trial designs, including dose escalation and expansion cohorts, biomarker-driven studies, global, multicenter trials
• Serve as a key member of the Clinical Operations leadership team
• Partner closely with Clinical Development / Medical, Regulatory Affairs Biometrics (Data Management & Biostatistics), Pharmacovigilance/Safety, Biomarkers/Immunology, CMC, Device, and Supply Chain
• Ensure alignment across functions on study strategy, timelines, and deliverables
• Contribute to clinical development plans and regulatory strategies
• Assist in forecasting and tracking clinical operations expenditures
• Ensure efficient use of resources across programs
• Partner with Finance and leadership to support long-range planning
• Ensure all clinical trials are conducted in compliance with: ICH-GCP, FDA, EMA, and global regulatory requirements, Company SOPs and quality standards
• Oversee inspection readiness activities and participate in regulatory inspections and audits
• Drive a culture of quality, risk management, and continuous improvement
• Ensure appropriate oversight of safety reporting, including oncology-specific considerations such as immune-related adverse events
• Build, lead, and mentor a high-performing Clinical Operations team
• Define roles, responsibilities, and career development paths
• Support hiring and onboarding of clinical operations staff
• Foster a collaborative, accountable, and solutions-oriented culture
• Serve as a coach and escalation point for complex operational challenges
• Establish and refine clinical operations processes, SOPs, and governance structures
• Implement scalable systems and tools to support portfolio growth

Requirements:

Experience:

• 12+ years of clinical operations experience, including significant leadership responsibility
• Demonstrated experience overseeing oncology clinical trials across multiple phases
• Prior experience at a trial sponsor (early-stage biotech/pharmaceutical company preferred)
• Proven success managing CROs and external vendors
• Experience supporting global clinical trials

Education:

• Bachelor’s degree in life sciences or equivalent by a combination of education and experience. Additional clinical trial certifications (e.g., ACRP, SOCRA) are a plus.

  Knowledge/Skill:

• Strong scientific acumen and ability to grasp complex scientific and technical concepts.
• Strong knowledge of 21CFR, ISO, ICH, GCP, and relevant regulations, standards, directives, and guidance is essential.
• Strategic thinker with strong execution focus
• Exceptional communication, organizational, and problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced, deadline-driven matrix environment.
• Ability to manage complexity, ambiguity, and competing priorities
• Track record of building and scaling clinical operations teams

Supervisory Responsibilities:

This role currently supervises a team of Clinical Trial Managers and is expected to recruit, train, and manage a scalable clinical operations team.

Working Conditions:

Specify work environment:

• The work environment shall be split between a virtual office environment and the Company headquarters in Des Moines, IA and Fort Lauderdale, FL.
• Domestic and International travel up to 30%
• Must have current passport or willingness to obtain immediately
• Must be able to successfully pass a background check, drug testing, and other applicable vendor credentialing requirements
• Ability to lift up to 35 pounds
• Regularly required to stand, sit, talk, hear, and use hands
• Prolonged periods of sitting and standing

Syncromune is an Equal Opportunity Employer.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range: $250,000-$275,000

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.