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Executive Director, Rare Oncology

Location Barcelone, Catalogne, Espagne Boston, Massachusetts, États-Unis ID de l'offre R-183067 Date de publication 10/23/2023

Executive Director Rare Oncology, Clinical Development

Location:

Barcelona, Spain, Mississagua, Ontario, Canada; or Boston, Mass. USA

Reports To:

Vice President, Clinical Development, Bone Metabolism & rare tumors, Alexion

This is what you will do:

The Executive Director Rare Oncology is responsible for overseeing 2 or more programs, providing oversight/guidance/mentoring to the Clinical Development, Clinical Operations and business development organizations, serving on cross-asset strategic teams (e.g., disease strategy team) and providing input to strategic decisions at the Therapeutic Area (TA) Strategy Team and Global Medicine Team meetings. Manages from Senior Directors to clinical scientists directly and may support / oversee other staff within the TA. Provides overall support to regulatory strategy and commercial strategy when required.

The Executive Director Rare Oncology  is also responsible for early identification of Key HCPs networks for rare oncology indications (at the Global level), setting up & maintain robust relationships with Global Strategic Consulting Groups, experts and academic centers and consortia in key areas of interest, and working cross-functionally with all relevant internal stakeholders (COM, ClinDev, ClinOps, PAG, Reg, Access..) to define the clinical development strategy and plan and and provide input to the scientific and operational matters. The Incumbent must be fluent In English, scientifically and medically solid, hold strong ethical standards, and have robust leadership skills and influential abilities.

You will be responsible for:

  • Typically lead 2 program teams or more and drive the successful execution of clinical studies/programs/research strategies; define and manage the benefit to risk profile of our products.
  • The Executive Director may oversee a Disease Area franchise (ie: Neuro-Oncology or Hemato-Oncology) within the TA, including several programs.
  • Representing Clinical Development on the Global Program Team (GPT) and Global Medicine Team in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee); advance understanding of the impact our therapies have on the pathophysiology of rare and orphan diseases through scientific discourse and interpretation of data
  • Fostering the development of Medical Directors and Clin Dev Scientists and/or fellows. Leading and overseeing 2 programs and the preparation and execution of a clinical development strategy and related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
  • Providing scientific and medical input (consultative services) to other R&D, commercial, translational, medicine and business development functions and leads and or oversees clinical activities to support external evaluations and due diligences.
  • Acting as an expert consultant on rare oncology to the Vice-President and Therapeutic Area Head, as well as to other Senior Executives in Alexion and AstraZeneca

  • Representing Alexion Clinical Development in to Key External Stakeholders & Patients Associations.
  • Establishing & maintaining close relationship with relevant Global Consulting Groups & driving proper execution of External Scientific Engagement Plan at Regional/National level.
  • Representing Alexion Clinical Development to internal (R&D management, cross-functional development teams and executive committee) and external (academic, regulatory, and medical) communities.
  • Overseeing a cross-functional team which develops the clinical components of the Clin Dev Plans.
  • Serving as the Clinical input to Global Development Team / Subteams and medical expert for the clinical study teams.
  • Overseing the writing of the clinical sections of the CTD, white papers, expert opinion reports, and regulatory responses
  • Liaising internally (and leading when required) with other members of the CDP to drive program strategy and CDPs. Coordinate communications and planning medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical Science) as it relates to clinical development study design, execution, and interpretation of results. Serves as the medical expert on the global product labelling team
  • Driving awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review
  • Writing or contributing to white papers, expert opinion reports, and regulatory responses
  • Driving clinical support of business development activities, such as due diligence and research collaborations
  • Critically evaluating available information about diseases of interest to the therapeutic area and the competitive landscape and synthesizing information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
  • Determining appropriate advisory boards experts
  • Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management
  • Supervise medical monitors on individual studies.

You will need to have:

  • MD with 7+ years of experience in clinical practice in Oncology or related disciplines and clinical research (Experience in Neuro-oncology and/o pediatric oncology will be valued)
  • Exposure to regulatory interactions, such as having prepared documents and attending regulatory meetings with FDA, EMA or other regulatory agencies.
  • Participation in Advisory Boards/Committees
  • Experience designing and executing multinational clinical trials required.
  • Demonstrated ability to lead cross-functional teams.
  • Experience supporting business development activities.
  • The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

  • High level degrees such as PhD or MSc in related discipline
  • Understanding of basic statistics and clinical data management/interpretation 

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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 authorization and employment eligibility verification requirements.

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