Kelly Services is currently seeking a Evidence Delivery Associate Director position in Gaithersburg, MD to work a contract assignment of 1 year for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.
Primary Responsibilities of the
Evidence Delivery Associate Director position includes:
Position Title - Evidence Delivery Associate 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.
Medical Evidence and Observational Research (MEOR) organization is accountable for the operational delivery of global strategic studies required to generate the evidence to build the confidence on therapies and additional observational, interventional and externally sponsored research required by Global Product Teams and Global Medical Teams.
Evidence Delivery Associate Director (EDAD) 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, the EDAD will support MEORs 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 EDADs 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, 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.
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 the companys 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):
Responsible for leading the review and evaluation of all ESR proposals and protocols, in line with a products 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
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, utilising appropriate Company systems to facilitate awareness and understanding of ESR budget commitments (e.g. forecast versus actuals)
Provide oversight to local Marketing Companies (MCs) 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 patients physician
Education, Qualifications and Experience:
Bachelors 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
Education and Experience Requirement of the
Evidence Delivery Associate Director position
Bachelors degree required preferably in medical or biological science or equivalent by experience.
Contract assignment, duration 12 months.
Work schedule: full-time, first shift.
Kelly Temporary Employee Perks:
Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase and the coverage is portable*
Service bonus plan and Holiday pay plan, if qualified
Weekly electronic pay options
Free online training campus available
Exclusive online employee community
This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:
Thank you for your interest in the assignment.
With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
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Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.