Clinical Trial Project Director- Global Medical Affairs

Gaithersburg, MD 20878

Posted: 09/24/2018 Industry: Other Area(s) Job Number: 31620

Clinical Trial Project Director- Global Medical Affairs

The Clinical Trial Project Director Global Medical Affairs (GMA) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on therapies and support our internal stakeholders with medical insight and expertise. GMA provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. GMA aims to lead in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do. This role will be responsible and accountable for the operational planning, delivery, oversight and budget management of company sponsored studies and/or externally sponsored studies and/or Early Access Programs. The EDAD will work hand in hand with the scientific study leader who is responsible for all scientific aspects throughout all stages of the study (epidemiologist for observational studies, Medical Affairs Leader for interventional studies). In addition, this role will support MEOR’ s continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials. The focus will be on one of the three main types of work as described below. Specific activities/responsibilities per type of study: Company Sponsored Observational and Interventional Research: Input into Study Design Concept (SDC) • Responsible to provide the insights on operational feasibility during the SDC development process. Accountable for protocol • Drive the process of coordinating protocol development by ensuring input of all relevant cross functional (internal) and external stakeholders. • Responsible to provide input on operational feasibility of the protocol Manage Study Governance (post SDC) • Coordinate all internal, study governance processes (e.g. MEORT, MARC, LSPC, Clinical Challenge) External Service Provider Management • Lead the process for selection of External Service Providers (ESPs), including Clinical Research Organizations (CROs) • Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and ensure that study delivery is within time, cost and quality limits • Manage study specific issues and escalations with ESPs/CROs. Stakeholder Management • Set up study team and manage study sourcing • Effective collaboration with the scientific/medical counterpart, the Epidemiologist/Medical Affairs Leader (MAL) respectively, as well as other internal cross functional global roles • Report study updates from a time, cost and quality perspective to internal stakeholders (e.g. Evidence Program Director (EPD)) • Clarify and document an effective communication approach, as well as roles and responsibilities between the MEOR stakeholders, local and External Service Providers. • Ensure appropriate level of involvement of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during study design and delivery Manage study finance: • Develop and maintain the overall study budget (internal and external study costs) • Keep transparency on study budget and changes through relevant systems (s.a. ACCORD) and platforms (Planning Performance and Control (PPC) meetings) and obtain approval for budget changes • Work with procurement on study agreement and manage subsequent out of scope changes for ESP/CRO • Manage and reconcile Contracts, POs and invoices • Financial audit readiness and Sox attestation Other Project Management activities • Deliver studies to agreed timelines (scorecard), within the approved budget and according to quality standards. • Ensure global oversight over the operational study start up, implementation and closure and ensure inspection readiness • Lead study related change management within business strategy, s.a. assessment of scope changes. • Ensure Compliance with Procedural Documents, Standards and Policies, international guidelines and local regulations at any time, and report compliance breaches • Undertake feasibility assessments with internal and external stakeholders • Manage study system reporting • Lead the study and manage the study team stakeholders (e.g. core team, extended team, delivery team Externally Sponsored Scientific Research (ESR): Governance: • Responsible for leading the review and evaluation of all ESR proposals and protocols, in line with a product’ s scientific strategy, within a Therapeutic Area (TA) • Ensure operational compliance with policies and procedures for ESRs globally • Responsible for implementation of ESR quality framework within a TA Delivery: • Manage across a range of global and local cross-functional stakeholders to ensure all obligations and responsibilities for ESR (e.g. drug supply, contracting, regulatory documentation, publication review etc.) are met • Manage external stakeholder, e.g. external Investigator and Sponsoring institutions • Lead ESR portfolio financial forecasting and budgeting for assigned ESR studies/portfolios, utilizing appropriate Company systems to facilitate awareness and understanding of ESR budget commitments (e.g. forecast versus actuals) • Provide oversight to local Marketing Companies (MC’ s) to ensure all operational delivery aspects of ESR are achieved within agreed timelines and budgets, to expected levels of quality, and in line with the legal and compliance requirements, escalating issues around non-attainment of performance metrics as appropriate • Lead and manage the delivery of complex multi-product/country/cross regional collaborative ESR studies. Co-ordinates complex ESR in conjunction with MCs, overseeing Medical Affairs specialists and/or study management specialists to ensure compliance with project management guidelines, external regulations and internal processes/policies to enable high quality research • Acts as the first point of contact for local MC operational enquiries • Tracks all ESR study time, cost and quality KPIs, taking corrective action as required. In doing so, guides the MC in the changing of ESR study milestones and finances in light of changing needs and requirements to ensure that deliverables continue to be efficiently and effectively met Early Access (EA) /Named Patient Supplies (NPS): • Lead the planning, implementation and delivery of EA programs • Collaborate with vendors to ensure the EA Program operational aspects are effectively undertaken and that they have clear remits for delivery to ensure EA Program is on time, on budget and of high quality. • Manage the resolution of program specific issues and escalations with internal (e.g. Global Clinical Leads, Chief Medical Office, supply chain representatives) and external stakeholders • Manage the review process of NPS requests to ensure timelines for decision making are adhered to, utilizing appropriate Company systems, so that a decision on the request can be returned to the patient’ s physician REQUIRED: Bachelor’ s degree required preferably in medical or biological science or equivalent by experience. Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area. Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools. Scientific awareness and extensive knowledge of observational study guidelines and SOPs Extensive knowledge of early and late stage Pharmaceutical Development Ability to effectively work with Clinical Research Organizations/External Providers. Proven ability to interact widely and effectively within the company across regions, functions and cultures. Experience and knowledge within compliant management of Externally Sponsored Scientific Research Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment Open to periods of travel
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