Global Head of Late Phase Data Management Astrazeneca
Gaithersburg, MD

Job Description

Global Head of Late Phase Data Management

Development Operations

Cambridge / Gothenburg / Gaithersburg / Warsaw

As AstraZeneca launches the Growth Through Innovation strategy, our new R&D model - aligned with the commercial units - will help us deliver new medicines to patients and drive a sustainable, innovative and future focused pipeline.

2018 was a milestone year for AstraZeneca's journey to return to growth - fuelled by the innovation and delivery from our Science Units. The new R&D structure is designed to help us build on this proud legacy of scientific contribution, and ensure we are positioned to continue to translate our innovative science into even more life-changing medicines for patients.

Development Operations brings together all the skills groups to drive critical operational activities for early and late stage medicines development.

We have deep and specialist expertise in study and site management, data management, technical systems and processes, and in working with CROs and partner organisations to ensure the fast, efficient, ethical and quality delivery of our clinical trials in countries around the world.

We are nearly 2,500 people operating in more than 45 countries across the globe - partnering with the early and late TAs to meet the demands of extensive clinical trial programmes involving many thousands of patients.

The Global Head of Late Phase Data Management is accountable for end to end data flow and data quality in AstraZeneca sponsored late phase studies up to database lock. They are accountable for developing and executing late phase data management and data flow vision & strategy across the late portfolio including, sourcing and delivery models, sponsoring strategic partnerships, capability development and leading and driving innovation aligned with the latest technology. This role will lead and influence significant levels of business change within their own organisation and across the broader organisation. This role collaborates extensively with business partners in Oncology & BioPharmaceuticals Therapeutic Areas, Development Operations and external alliance partners to ensure global delivery of end to end data management activities to timeline and high-quality standards across a large late phase portfolio.Accountable for driving a global culture of delivering to established milestones with the highest degree of customer satisfaction, emphasizing communication and transparency of operations. Responsible for Line leadership of staff globally, accountable for recruitment, development and succession planning in multiple geographies. Is a member of the Biometrics Operations Leadership Team.

Responsibilities:

* Accountable for end to end late phase data management and flow, including overall accountability for CRF and third party data and transparency of data flow, across a large portfolio of large scale pivotal studies, internal and external delivery models
* Ensure close partnership with senior stakeholders involved in data flow, engendering a positive, collaborative and transparent partnership that holds each other accountable for shared deliverables
* Ensure globally, that clinical trial data provided for reporting or exploratory purposes are high integrity, high quality, timely and fit for purpose to meet the needs of the R&D organizations
* Develop and Execute the Late Phase Data Management strategy that is aligned with the Biometrics Operations & Development Operations organization vision, principles, and priorities.
* Oversee and guide establishment of asset level strategies to ensure consistency, efficiency, and excellence in the application of standards, and establishment of advanced, predictive data monitoring practices.
* Partner with Standards Group and across the R&D Organisations to influence and guide clinical trial data standards to enable the right balance of efficiency, flexibility and value in how data is handled and used
* Establish leading and lagging indicators of internal and external performance; use these to inform continuously improving late data management services
* Assess the competitor and external partner landscape for new opportunities and/or industry trends for innovative approaches and working internally to engage, collaborate with and influence relevant senior stakeholders across the R&D organisations
* Establish and maintain strong relationships with collaborators and suppliers, and ensure appropriate oversight to enable fit for purpose delivery of clinical trial data
* May serve as an AstraZeneca representative on Executive Steering Committees (ESC) for data management alliances and be the key interface with Senior Executives/C-Suite leadership assigned from the vendor (vendor ESC counterparts).
* Strategically engage with Industry bodies to identify key areas, issues, trends or emerging initiatives where direct involvement of AZ would be beneficial, and provide or organise that involvement.
* Ensure Global Capacity Management and Alignment for DM: Ensure appropriate resources are available (internal and/or external) and assigned appropriately to meet demand of data management function
* Attract, develop and retain top talent, succession planning & capability development

You must meet the essential qualifications and experience listed below:

* Bachelor or Master Degree in Biological Sciences, Statistics, IT or related field with a strong understanding of biomedical data and analytics.
* Extensive experience in a pharmaceutical, biotech, CRO or Regulatory Agency
* Strategic mindset and thinking with ability to translate strategy to operational execution. Ability to deliver with agility & high quality at a fast pace.
* Track-record of innovation delivering improved business outcomes
* Strong leadership capabilities including ability to drive results and collaborate, communicate, network and influence effectively across a wide range of internal and external stakeholders at varying levels of seniority
* Strong Experience of leading teams working with and delivering through strategic partners and third-party vendors
* Extensive experience in Clinical Trial Operations with a clear understanding of managing clinical data from multiple sources
* Demonstrated knowledge of regulatory requirements supporting clinical trials and submissions
* Ability to drive and champion global change across multiple functions and actively advocate and implement more efficient and effective methods / processes

Date advert posted: 11th June 2019

Expiry date for applications: 11th July 2019

We have a limited time window to conduct this process, as a result please note the following;

* We will not be contacting applicants to discuss their application.
* Shortlisting and selection of individuals will be completed by a combination of paper based assessment with individual interviews where knowledge gaps need to be closed in order to choose best candidate
* The respective hiring managers or HRBPs may be in touch for any additional information to close any obvious knowledge gap as needed in order to make a robust selection decision.
* Given the above process, please make it clear in your application how you meet the essential criteria.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.