Location: Toronto, Canada – least 3 days a week Onsite (Can be US Citizen and obtain a TN Work Visa Etc.)
LOA: 6-12+ Months
Start Date: October 21st
JD:
- The Evidence Delivery Director (EDD) 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 EDD 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, the EDD will support 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.
- Usually, the EDD’s focus will be on one of the three main types of work as described below.
Responsibilities:
- 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. ERT, MARC, LSPC, ClinicalChallenge)
- External Service Provider Management
- Lead the process for selection of External Service Providers (ESPs), including Clinical Research Organisations (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/Global Medical Affairs Leader (GMAL) respectively, as well as other internal cross functional global roles
- Report study updates from a time, cost and quality perspective to internal stakeholders
- Clarify and document an effective communication approach, as well as roles and responsibilities between the stakeholders, local client 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 Clients 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 client 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
- Management of study Governance processes
- Management of cross-functional internal and external stakeholders
- Finance Management
- Overall Project Management to deliver according to cost, time and quality
- Risk Management, Quality Management
- Study compliance
- Team Leadership and team resource management
Skills:
- 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 Organisations/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
Canada (Hybrid): Clinical Evidence Director (235824)
