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Dispatch Bio · 10 hours ago

Head of Clinical Operations

Philadelphia, PA

Full-time

Hybrid

Director/Executive

$250K/yr - $350K/yr

12+ years exp

Dispatch Bio is a startup biotechnology company focused on engineering a universal treatment for solid tumors through novel cell therapies. The Head of Clinical Operations will lead multiple clinical studies globally, ensuring compliance with regulatory guidelines while managing budgets and timelines.

BiotechnologyHealth CareTherapeutics

Hiring Manager

Erica Arkin

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

Qualification

Clinical operations managementOncology clinical trialsCell therapy experienceFDA guidelines expertiseClinical Practices (GCP)Early phase trial experienceProject managementOrganizational skillsCommunication skillsCollaborationProblem solving

Required

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

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