Evidence Portfolio Delivery Director
2 weeks ago
BioPharmaceuticals
Medical
(
BPM
) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (
AZ
) therapies and support our internal stakeholders with medical insight and
expertise
.
BPM
provides medical leadership with market participation and connectivity while also
impacting
the life cycle planning and execution of all our products.
BPM
aims to lead AZ in achieving scientific leadership, being
a great place
to work, and keeping patients at the core of everything we do.
The
BioPharmaceuticals
Medical
Global
Evidence
Portfol
io Delivery
organization is accountable for the operational delivery of global strategic studies
required
to generate the evidence to build the confidence on AZ therapies and
additional
observational,
interventional
and externally sponsored research required by Global Product Teams and Global Medical Teams.
About the role:
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
BPM Evidence’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.
Usually, the EDD’s 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.
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 (
G
MAL) 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
BPM Evidence
stakeholders, local
AZ
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 AstraZeneca 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 AZ 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 AZ 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, utilising
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 programmes
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, utilising
appropriate Company
systems, so that a decision on the request can be returned to the patient’s physician
Roles & Responsibilities:
Independent of the study type, key accountabilities in the remit of the Evidence Delivery Director are:
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
Requirements:
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
Great People want to Work with us Find out why:
GTAA Top Employer Award for 10 years
Top 100 Employers Award
Canada’s Most Admired Corporate Culture
Learn more about working with us in Canada
View our YouTube channel
Are you interested in working at AZ, apply today
AstraZenecais an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by
emailing
AZCHumanResources@astrazeneca.com
.
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