Evidence Delivery Associate Director

Business Area: BioPharmaceuticals

Medical

(

BPM

) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on 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 AstraZeneca in achieving scientific leadership, being

a great place

to work, and keeping patients at the core of everything we do. About the role: Evidence

Delivery

Associate Directors

(

EDAD

)

will

lead or

support

the operational planning, delivery,

oversight

and budget management of

company

and/or externally sponsored

research

.

They may also help coordinate the efforts of extended team members, notably the scientific study leader

(epidemiologist for observational studies, Medical Affairs Leader for interventional studies).

The

EDAD

may own specific areas or deliverables

within a study, or in some cases,

assume the accountabilities of a team leader

for study delivery

. In addition, the

EDAD

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

EDAD’s

focus will be on one of the three main types of work as described below. Roles & Responsibilities: Company Sponsored Observational and Interventional Research: Company sponsored observational and interventional research

Support/coordinate

protocol development

and finalization

Manage Study Governance (post SDC)

Support/c

oordinate all internal,

stu

dy

governance processes (e.g.

ERT

, MARC,

LSPC, Clinical

Challenge

)

External Service Provider Management

Provide input into

the

selection of External Service Providers (ESPs)

, including Clinical Research Organisations (CROs)

Support

strategic handover meetings and kick off meetings

Perform CRO oversight

to

help

ensure

project delivery within time,

cost

and quality

Collaborate with CRO/ESP to ensure the study

operational aspects are effectively undertaken

and that they have clear remits for delivery

Manage study specific issues and escalations with ESPs/CROs

Stakeholder Management

Support

Project team

set-up

and study sourcing

activitie

s

Support 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

for areas of responsibility

from a time,

cost

and quality perspective to

internal stakeholders (e.g.

Evidence Delivery

Director

(

EDD

))

Support implementation and upkeep of

an effective

communication

approach, as well as roles and

responsibilities

between

the

BPM Evidence

stakeholders

, local

AZ

and External Service Providers

Coordinate efforts/input

of the external scientific community (

e.g. (Inter)national Coordinating Investigators,

Steering/Executive Committee)

during

project design and delivery

Manage study finance: If leading a study, d

evelop and

maintain

the overall study budget (internal and external study costs)

Ensure

transparency

over

areas of

budget

responsibility

by updating

through relevant systems (s.a. ACCORD) and platforms (PPC meetings)

and

obtaining

approval for budget changes

Work with procurement on project agreement and manage

subsequent

out of scope changes for ESP/CRO

Manage and reconcile Contracts,

POs

and invoices

Support f

inancial audit readiness and Sox attestation

as needed

Other

P

roject Management activities

as applicable Support delivery of

projects

to agreed timelines (scorecard), within the approved budget and according to AstraZeneca quality standards

Support

global oversight over the operational study start up, implementation and closure

and ensure inspection-readiness

Support implementation of

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 f

easibility

assessments

with internal and external stakeholders

Manage study system

s

reporting

External

ly

Sponsored Scientific Research (ESR): Manage across a range of g

lobal

and

loc

al 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

Support 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

ensur

e

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

m

anage

aspects of

the delivery of complex multi-product/country/cross regional

c

ollaborative

ESR

studies.

Co-ordinates complex

ESR

in conjunction with MC

s

, 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 projects

Acts as the first point of contact for

local

M

C

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

Ensure operational

quality and

compliance with policies and procedures for ESRs

globally

Early Access (EA) /Named Patient Supplies (NPS): Leads aspects of the planning,

implementation

and

deli

very of E

A

programmes

Perform

vendor

oversight

to ensure EA Program

delivery

to

time,

cost

and quality

Collaborate with vendors to ensure the EA Program

operational aspects are effectively undertaken

and that they have clear remits for delivery

Manage

triaging 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

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 a

nd

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

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