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Oncology Medical Evidence Lead

Location Basiglio, Lombardy, Italy Job ID R-120149 Date posted 22/11/2021

At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.

Reporting to the Head of Medical Affairs Oncology, the Oncology Medical Evidence Lead will be responsible and point of contact for OBU, including Market Access, for all the evidence generation activities in Oncology (except R&D) cross Franchises (planning, delivery and budget management), with the aim to generate new medical evidence and to show the value of Oncology AstraZeneca’s products in order to address the needs of patients, healthcare professionals, payers and other healthcare decision-makers around the world.

Medical evidence provides deep insight into the impact of healthcare in the real world, delivering new scientific knowledge that cannot be generated in other ways.

MAIN DUTIES AND RESPONSIBILITIES

Reporting to the Head of Medical Affairs Oncology, you will be responsible for:

  • Responsible for the planning, project management and delivery of scientific studies (ESRs, AZ sponsored RWE and AZ sponsored ph4 studies) and evidence generation to support Oncology Business and value claims, in alignment with the Oncology Strategy
  • Responsible for governance processes and standard operation procedures
  • Informs disease area and product strategy, trial design and regulatory claims, providing additional value to our clinical programmes throughout the product life cycle
  • Externally, has the goal to deliver the medical evidence to healthcare decision-makers that gives them the confidence they need to ensure that patients have access to AstraZeneca’s medicines
  • Project/Programme Management, including budget and resource management, in evidence generation with Medical and Payer perspectives
  • Support the development of plans for Evidence generation, for specific brand(s) across AstraZeneca Oncology portfolio, and prepare for project prioritization
  • Bridge medical, market access and commercial agenda, by establishing and developing Evidence requirements, ideas and activities to yield robust value evidence and develop value propositions
  • Assess feasibility of study proposals
  • Coordinate all internal project review & governance processes for internal AstraZeneca initiatives as well as ESR proposals
  • Communication and collaboration with the Global & Regional counterparts, experts and stake holders
  • Data access and collection in RWE studies
  • Quality assurance in Evidence Generation Studies
  • Writing of relevant sections of Study Design Concepts, Study Protocols, Case Report Forms, Study Reports and Manuscripts for Publications
  • Ethical applications and interaction with Authorities and registry holders (e g National Boards of Health and Welfare regarding use of health care data/registries)
  • Study registration in applicable systems and result posting according to Transparency policy
  • Write and negotiate Agreements with scientific consultants, investigators, service providers and others as applicable 
  • Initiate and follow-up collaboration with external investigators, clinicians, payers, consulting companies, external service providers and other organizations
  • Facilitate study drug supply and ensure patient safety reporting, as applicable, in ESR projects
  • Collaboration and interaction with AstraZeneca other MCs, Regional & Global Medical Affairs, R&D etc regarding Evidence activities
  • Assure correct quality in accordance with written procedures and current legal requirements and internal standards
  • Manage all activities and Account relationship according with Company Values, Code of Conduct, Guidelines/Internal procedures and Italian

ESSENTIAL REQUIREMENTS

  • Scientific Degree equivalent degree
  • Significant experience (>5 years) in the pharmaceutical industry with at least 4 year in Medical department, preferably in the area of Clinical Development or Medical Affairs OR in a CRO working with pharma company
  • Experience in the Oncology therapeutic area (at least 3 years)
  • Project management experience
  • Knowledge of Italian and EUlaws and technical rules for clinical trials implementation and delivery
  • People management experience
  • Extensive knowledge of Observational Study Methodologies
  • Strategic mindset with a broad business acumen
  • Proficiency in spoken and written English and Italian
  • Proven ability to interact widely and effectively within the company across regions, functions and cultures
  • Ability to set and manage priorities, resources, performance targets and project initiatives in a multinational matrix environment
  • Good problem solving and conflict resolution skills
  • Integrity and high ethical standards

DESIRABLE REQUIREMENTS

  • Experience from Clinical Research/Operations (i e hands on work with Clinical Trial Management in the pharmaceutical industry)
  • Demonstrated project management skills including scope, budget, timeline, resource management and use of associated tools.
  • Ability to effectively work with External Service Providers
  • Ability to look for and champion more efficient and effective methods/processes


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

10000965 F MABM Oncology

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.