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Alexion

Global biopharmaceuticals focusing on rare diseases

Executive Medical Director - Clinical Development Hematology

Biology & BiotechPosted on Nov 9
Full-timeBoston, MA, USA

About the Job

Requirements

  • An M.D. or equivalent is required.
  • At least 7 years of experience in clinical development, clinical research, global regulatory work, and product development expertise is required.
  • Experience preparing documents and attending meetings with the FDA and other regulatory agencies is required.
  • Experience designing and executing multinational clinical trials is required.
  • Demonstrated ability to lead cross-functional teams in defining clinical strategy and clinical study design is required.
  • Experience supporting business development activities is required.
  • A Ph.D. in a related discipline is desirable but not required.
  • Clinical training is preferred with the M.D. or equivalent.
  • Employees must be able to use a computer; communicate by phone, video, and electronic messaging; engage in problem solving, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours, with or without accommodation.

Responsibilities

  • Typically lead two program teams and drive successful execution of clinical studies, programs, and research strategies; define and manage the benefit-to-risk profile of products.
  • Represent Clinical Development on the Global Program Team and Global Medicine Team in presentations to management and review committees, and advance understanding of therapy impacts on rare and orphan disease pathophysiology through scientific discourse and data interpretation.
  • Foster development of Medical Directors, Clinical Development Scientists, and fellows; lead and oversee two programs and prepare and execute clinical development strategies and related documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
  • Provide scientific and medical consultative services to R&D, commercial, translational, medicine, and business development functions, and lead or oversee clinical activities supporting due diligence.
  • Represent Alexion Clinical Development to internal R&D management, cross-functional development teams, and executive committees, and to external academic, regulatory, and medical communities.
  • Oversee a cross-functional team developing clinical components of the Clinical Development Plan; provide clinical input to Global Development Teams and subteams and serve as a medical expert for the clinical study team; oversee writing clinical sections of the Common Technical Document, white papers, expert opinion reports, and regulatory responses.
  • Liaise with Clinical Development Plan members to drive program strategy and plans; coordinate communications and planning among medical functions including Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology, and Medical Science for study design, execution, and results interpretation; serve as the medical expert on the global product-labeling team.
  • Monitor internal and external scientific, clinical, competitive, and regulatory developments that could affect the development plan, including attending major scientific conferences, participating in competitive intelligence activities, and periodically reviewing literature.
  • Write or contribute to white papers, expert opinion reports, and regulatory responses.
  • Drive clinical support for business development activities, including due diligence and research collaborations.
  • Evaluate information about diseases of interest and the competitive landscape, and synthesize it to support dissemination and incorporation into clinical development programs, asset plans, and therapeutic area strategy.
  • Determine appropriate advisory board experts.
  • Work cross-functionally with colleagues in biostatistics, data management, clinical pharmacology, commercial, regulatory, and project management.
  • May supervise other medical monitors on individual studies.

Desired Qualifications

  • Advanced knowledge of the assigned therapeutic area and the capability to interpret, discuss, and represent trial- or program-level data.
  • At least 7 years of industry experience in clinical development.

About the Company

Alexion

Global biopharmaceuticals focusing on rare diseases

Alexion, now the rare disease group within AstraZeneca, develops and sells therapies for rare and ultra-rare diseases by targeting the complement immune system. Its drugs, such as Soliris and Ultomiris, inhibit the C5 component to slow or stop disease processes, while Strensiq and Kanuma address specific metabolic disorders. It differentiates itself through a deep focus on complement biology, pursuing first- or best-in-class therapies, and using a strategy that blends internal R&D with acquisitions to expand its pipeline. Its goal is to improve outcomes for patients with rare diseases and bring these therapies to a broader international market using AstraZeneca’s scale and capabilities.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Boston, MA
Founded
1992

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