Executive Medical Director (Dermatology)

Executive Medical Director (Dermatology)

PPD - Pharmaceutical Product Development

Belgium

Description

This role serves as a medical strategy leader for the asset development and clinical study teams. Works in collaboration with and on behalf of clients to design and/or oversee implementation of full asset development programs with focus on clinical and regulatory strategy. Applies firsthand knowledge of state-of-the-art clinical development planning for client development programs across a range of drug classes and platforms, including small molecules, vaccines, biologics, biosimilars, diagnostics and devices. Applies deep therapeutic area and indication-specific knowledge of asset development program execution to provide strategic direction and risk mitigation strategies to internal teams operationalizing clinical studies in full asset programs.

Qualifications

Education and Experience:

  • MD or equivalent with experience implementing therapeutic programs across one or more therapeutic areas and/or drug classes;
  • Sub-specialty training or significant product development experience in Dermatology preferred;
  • Significant experience contributing to product development team activities from early development through marketing application and/or launch to include 15+ years of pharmaceutical industry experience;
  • Experience overseeing the design and execution of at least one full clinical program from first-time-in-human or proof of concept studies through submission of marketing application;
  • Direct experience with the creation and implementation of full asset development including pre-clinical, clinical, regulatory, CMC and (if applicable) biomarker strategy development.

Knowledge, Skills and Abilities:

  • Thorough understanding of overall biologic/pharmaceutical product development process, from pre-clinical through post-marketing, including all stages of development and all functional roles;
  • Experience developing strategies to support first-time-in-human studies through marketing application;
  • Therapeutic and indication-specific development expertise across one or more therapeutic areas and one or more drug classes, including deep knowledge of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and commercial landscape;
  • Thorough understanding of core cross-functional concepts (e.g., preclinical, translational medicine, CMC) and major program requirements at different development stages;
  • Deep knowledge of important regulatory considerations and experience with FDA, EMA and other national regulatory authorities;
  • Experience as a medical strategy leader on one or more asset development teams;
  • Experience with KOL and investigator interactions;
  • Strong decision-making and analytical skills;
  • Excellent communication and influencing skills;
  • Excellent organizational skills and detail-orientated leadership approach;
  • Flexibility to travel domestically and internationally;
  • Ability to work independently on multiple tasks in a fast-paced environment.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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