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Director Clinical Development

Director Clinical Development

Upsilon Global, , Spain, España
Hace 8 horas
Descripción del trabajo

Overview

Director, Clinical Development – Oncology. Location : Europe - preferred location of DACH region or Belgium.

Upsilon Global is seeking a Director of Clinical Development to lead clinical development, strategy and operations within the oncology portfolio of an expanding pharmaceutical company. In this role, you will work closely with the senior leadership team to design and execute clinical, medical and regulatory strategy, leading a matrix team to drive oncology assets through early- and late-phase development.

Key responsibilities

  • Oversee and steer the design and execution of the oncology portfolio, help to create the clinical development plan for new compounds, and pave a path towards regulatory approval.
  • Collaborate with industry partners and engage with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities.
  • Interact closely with the CMO and SLT members by making strategic proposals on platforms, including overall approaches and investments.
  • Lead and collaborate in a multidisciplinary team setting with a genuine interest and understanding of the science supporting the pipeline; commit to developing new treatments to address unmet needs in Oncology and / or Immuno-Oncology.
  • Steer clinical strategies and operationalization of portfolios and platforms in partnership with the SLT.
  • Own strategy formulation and operational planning, content, execution and delivery for assigned programs; drive integrated development, submission and publication plans.
  • Assume Program Lead responsibilities in assigned programs, in liaison with the program manager; lead the program core team.
  • Create and translate Target Product Profile into clinical strategy.

Key requirements

  • M.D. or PhD preferred, with strong scientific and clinical background in Immuno-Oncology and / or Oncology.
  • Minimum of 10 years of oncology drug development experience in biotech / pharmaceutical and / or academic settings, including leading clinical development programs from exploratory Phase I / II through late-stage development in Phase III and regulatory submission.
  • Thorough understanding of clinical and scientific methods used in clinical development studies, including novel study designs, companion diagnostics for patient selection, clinical pharmacology / translational modeling and biostatistics; experience with confirmatory Phase 3 trial design and dossier preparation / submission.
  • Experience with global health authority interactions (EMA, FDA, CDE); leading a drug development program to successful registration is an advantage.
  • Strong medical experience in overseeing and interpreting safety and efficacy data and ensuring appropriate safety oversight for studies.
  • Demonstrated leadership in a global matrix organization and the ability to drive execution across functions without formal line management authority.
  • Ability to apply situational management to mentor and accelerate capabilities of direct reports.
  • Application

    Click apply or contact Juliana Madiba at or .

    Seniority level

  • Director
  • Employment type

  • Full-time
  • Job function

  • Science, Research, and Health Care Provider
  • Industries

  • Biotechnology
  • Health and Human Services
  • Staffing and Recruiting
  • #J-18808-Ljbffr

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    Director Development • , , Spain, España

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