Senior Director, Rare Oncology - Barcelona, España - Alexion Pharmaceuticals,Inc.

Alexion Pharmaceuticals,Inc.
Alexion Pharmaceuticals,Inc.
Empresa verificada
Barcelona, España

hace 1 mes

Isabel García

Publicado por:

Isabel García

beBee Recruiter
Descripción

Location:
Barcelona, Spain


Job reference:
R-190606

Date posted: 01/29/2024


Senior Medical Rare Oncology

Location:

Barcelona, Spain


Reports To:

Vice President, Clinical Development, NF1 & Bone Metabolism, Alexion and dotted line to the Head of External Scientific Engagement


This is what you will do:

The Senior 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 Associate Directors and clinical scientists directly and may support / oversee other staff within the TA. Provides overall support to regulatory strategy and commercial strategy when required.


The Senior Director Rare Oncology is also responsible for early identification of Key HCPs networks for indications (at the Global level), setting up & maintain robust relationships with Global Strategic Consulting Groups in key areas of interest, and working cross-functionally with all relevant internal stakeholders (COM, ClinDev, ClinOps, PAG, Reg, Access.) to define SCG agenda and key questions to address/insights to collect.

He/she will also establish Strategic Scientific Engagement Plan for the MACT (Medical Advisor Clinical Trials)

Team:

drive MACT local execution, studies prioritisation (with COM & MACT), collaborate with MACT Study Lead to create appropriate material, and define Strategic Engagement Plan at national/regional level.


You will be responsible for:


  • Typically lead 2 program teams and drive the successful execution of clinical studies/programs/research strategies; define and manage the benefit to risk profile of our products.
  • 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 due diligences.
  • Act as an expert consultant on
- 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 with MACT team.
  • Representing Alexion Clinical Development to internal (R&D management, crossfunctional development teams and executive committee) and external (academic, regulatory, and medical) communities.
  • Overseeing a crossfunctional team which develops the clinical components of the Clin Dev Plans. Serve as the Clinical input to Global Development Team / Subteams and medical expert for the clinical study teams. Oversees the writing of the clinical sections of the CTD, white papers, expert opinion reports, and regulatory responses.
  • Liaising internally with other members of the CDP to drive program strategy and CDPs. Coordinate communications and planning bet 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 evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs,
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