Director, Patient Treatment Operations at Adaptimmune Therapeutics plc in Philadelphia, PA

PRIMARY RESPONSIBILITY

Develop, implement, and manage the Treatment Operations Organization. This person is responsible for supporting the clinical and commercial organization’s execution of patient treatment i.e. non-medical operations or market access activities). Develop the tools and processes to ensure smooth execution of each step of the patient journey once the patient is either a) enrolled in a clinical trial or b) commercially, when a patient is approved for treatment and beginning the treatment course.

KEY RESPONSIBILITIES

• Identify, evaluate and implement innovative strategies and technologies to address operational challenges associated with execution of the patient journey from diagnosis through treatment.
• Work with other internal functions (e.g. clinical operations, COE account managers) on the creation and deployment of tools and processes to optimize the time from patient qualification for the therapy to infusion.
• Develop, implement, and manage the processes for execution of patient apheresis and treatment
• Support for all stakeholders in the execution of the treatment (e.g. planning and scheduling apheresis, manufacturing, shipping, and infusion schedules)
• Coordinate all internal functions on execution of specific patient treatments
• Communication of relevant information to all stakeholders about the patient’s cell journey (e.g. status of manufacturing)
• Build relationships with clinical / commercial site operations personnel (e.g. cell therapy operations managers)
• Develop, maintain, and evaluate key performance indicators for patient treatment execution
• Ensure appropriate infrastructure is in place to deliver the treatment, including:
• Working with development and commercial leadership to establish and implement an apheresis and treatment center network strategy
• Manage the operational setup of new apheresis and treatment centers
• Establish site qualification criteria and conduct operational certification for apheresis/treatment (e.g. FDA Risk Evaluation and Mitigation Strategy (REMS) qualification)
• Track and maintain site certification and recertification needs
• Ensuring site training compliance versus needs / requirements
• Ensure that investigators and site staff have a thorough understanding of processes for treatment execution (e.g. Vineti portal, apheresis and infusion procedures, cell handling, shipping, etc.)
• Maintain process revisions and communicate timely updates to sites
• Clinical Site / COE Triage and Support
• Develop and manage a process for a single point of contact for all key stakeholders (e.g. patient, treatment provider, clinical scientist, COE account manager) for resolution of product supply issues for specific patients
• Respond to treatment operations questions as they arise
• Address issues with access/use of systems (e.g. Vineti)

QUALIFICATIONS & EXPERIENCE

Required

• Minimum of Bachelor’s degree in a relevant scientific field, and/or relevant scientific licensure (e.g. Registered Nurse); advanced degree preferred
• Previous experience in a matrix environment leading operational and/or supply chain functions in life science industries
• 7+ years experience (or equivalent) managing people
• 10+ years experience with industry-sponsored early stage / late stage clinical or commercial treatment operations in pharmaceutical, CRO, or biotechnology company
• Experience starting/standing up tools and processes within patient treatment sites (e.g. software deployment experience)
• Strong knowledge of clinical operations and the clinical site-specific regulatory process associated with cell therapy and/or blood products (e.g. GMP, GCP, FACT (Foundation for the Accreditation of Cellular Therapy)
• Ability to travel to sites

Desirable

• Experience with oncology, biologics or cell and gene therapy is preferred
• Management of geographically diverse teams (i.e. where direct reports may be in other geographies)

Experience in a startup environment, in particular starting up an operational supply chain organization in life sciences

SKILLS & COMPETENCIES

Required

• Highly motivated, independent, and a self-starter.
• Strong interpersonal skills and communication skills (both spoken and written).
• Ability to collaborate effectively with cross-functional team members, and external partners
• Sense of urgency and ability to work effectively to timelines to ensure delivery of key services, goals and objectives
• Ability to manage and develop people
• Strong leadership skills, self-motivated, adaptable to a dynamic environment
• Excellent planning, organization and problem solving abilities
• Excellent computer skills
• Ability to lead in a matrix environment
• Process/operational improvement skills (e.g. lean, six sigma, value stream mapping, etc)

Desirable

• Proven ability to manage multiple, sometimes complex and competing priorities to effective and efficient conclusion
• Ability to operate both strategically and tactically – understands and communicates the big picture while willing to roll up sleeves to get work done

Comfortable with ambiguity – able to work effectively in an evolving and dynamic environment, with experience developing structure and process to operate efficiently and effectively

DECISION MAKING AUTHORITY

The Director is expected to:

• Use good judgement in escalation of issues, and corrective actions associated with site performance
• Synthesize and share information between the sites, internal functions, and Adaptimmune Senior Management as appropriate
• Make decisions on hiring of internal managers / site support specialists
• Will manage ≥ 3 internal managers / site support specialists