Head of Clinical Operations

About us:

We’re a startup biotechnology company dedicated to engineering a universal treatment across solid tumors. We’re committed to the development of novel cell therapies, and we’re using viral vectors, universal targets, and novel cytokine biology to enhance CAR T activity. Our therapeutic approach has the potential to enable us to treat significant numbers of cancer patients. Our company was founded on pioneering work carried out in the laboratories of Dr. Carl June and Dr. Andy Minn (University of Pennsylvania), Dr. Kole Roybal (UCSF), and Dr. Christopher Garcia (Stanford University).

Our purpose is to help create a world where all cancer patients can be cured. We’re humbled by the opportunity to work together on some of the most pressing medical challenges of our time. At our company, you would become one of our early team members—not only playing a role in meeting our ambitious mission but also building our thriving culture. We are determined to deliver with urgency to discover new solutions and we always stay dedicated to scientific rigor; we have an ownership mindset because each and every one of us is integral to our success. Collaboration is core for us because we believe that by bringing people together with diverse perspectives, we make a stronger whole. And, we show we care about our work and each other by sharing feedback - ultimately in service of our vision to empower people to continue forward with their lives – cancer free.

The role:

Reporting to the Chief Medical Officer, the Head of Clinical Operations will provide strategic and operational leadership of multiple clinical studies globally to meet aggressive timelines, on budget, ensuring compliance with all relevant regulatory guidelines.

The successful candidate will immediately assume leadership for execution of two Phase 1 studies across two geographic locations (US & China). This hands-on position will directly manage the study CRO/vendors, budget, timeline, and supply management and will support efforts in the planning, execution, oversight, and reporting of all phases of clinical trials.

Key responsibilities:

• Lead all operational aspects of cross functional clinical programs, including strategic planning, communication, coordination, delegation, and stepping into direct action as necessary to make sure goals are achieved on time and on budget.
• Manage CROs, vendors, and other third parties. Oversight and training of all clinical trial-related partners, vendors and treatment sites.
• Lead the strategy and execution for identifying, recruiting, and retaining trial subjects.
• In partnership with the Regulatory and QA, develop and continuously improve clinical SOPs and GCPs and provide oversight of clinical monitoring quality & adherence to established processes and plans in compliance with GCP.
• Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks and make appropriate trade-offs of balancing risks with study deliverables and costs.
• Provide operational input to the development of study specific documentation including but not limited to: protocol, case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, pharmacy manual, project specific training plan, data review plan, statistical analysis plan, etc.
• Oversee set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.

Required experience & skills:

• Bachelor’s degree or higher in a scientific discipline
• At least 12 years of clinical operations management experience required
• Must have experience leading clinical trials within oncology and cell therapy
• Early phase (I and II) global trial experience
• Deep expertise in the application of FDA guidelines, Good Clinical Practices (GCP), ICH and applicable Standard Operating Procedures.
• Highly developed organizational and planning aptitude with demonstrated ability to manage complex plans and timelines with a sense of urgency
• Demonstrated ability to manage treatment sites and CROs (and other vendors) to meet study goals, timelines and budget
• Willingness to travel both nationally and internationally. Travel estimated at 20%
• Comfortable working in a virtual team with schedule flexibility to build and maintain relationships across time zones

Leadership Capabilities:

• Able to independently conceptualize a functional strategy and contribute to the enterprise strategy
• Demonstrated broad industry knowledge that informs strategic plans, decision making and complex problem solving
• Demonstrates a long-term planning aptitude that extends beyond immediate initiatives and that considers risk mitigation and feedback from within and outside the organization
• Demonstrated ability to build organizational capabilities that are fit-for-purpose for today, mindful of our resource constraints, while also being thoughtful about future scalability
• Able to define aspirational functional goals that are aligned to the company’s priorities; and leverage creative, cost-effective resourcing solutions to achieve objectives
• Focuses on how things are done as much as what is done; drives a high performing culture with a sense of urgency and commitment to high quality results
• Adept at both listening and offering opinions both at the functional and enterprise level
• Highly effective at developing and delivering audience-appropriate communications to share information and facilitate faster, better decision making
• Highly skilled at building cross-functional relationships in service of information exchange and collaborative problem solving

Preferred experience & skills:

• Solid tumor experience

Our values:

Our values guide everything we do. While capabilities and skills are vital, understanding how a potential new colleague would embody our values is central to our hiring decisions.

Determined to deliver:

By working with focus and passion, we can provide patients with the solutions they need.

Own every outcome:

We can reach new heights when we stay centered on our shared success.

Collaboration at the core:

When we band together, our work is better.

Feedback is fundamental:

Constructive and authentic positive feedback may be difficult to master but it is vital to our success.

Working here:

• We offer a highly competitive compensation package with meaningful ownership through equity
• Excellent coverage for medical, vision, and dental
• 401(k) with generous contribution
• Life insurance
• Flexible PTO policy
• Additional substantial benefits

We are an equal opportunity employer.

We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.