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Vertex Pharmaceuticals

Develops therapies for serious genetic diseases

Executive Medical Director - Clinical Development-Immunology

Biology & BiotechConfirmed live in the last 24 hours
Full-timeBoston, MA, USA

About the Job

Requirements

  • Comprehensive understanding of drug development from Phase 1 to Phase 4.
  • Recognized and respected authority in immunology or rheumatology.
  • Experience overseeing clinical development programs and their design and implementation.
  • Experience interacting with global regulatory agencies, including EMA, Health Canada, TGA, PMDA, and CDE.
  • Working knowledge of biostatistics, data management, clinical operations, and clinical pharmacology.
  • Experience filing and defending U.S. INDs and/or NDAs and/or their international equivalents.
  • Ability to provide hands-on assistance to junior staff when needed to help teams meet their goals.
  • Ability to function effectively in a team-based matrix environment.
  • Ability to work independently to resolve challenges and conflicts.
  • Computer skills, including familiarity with using AI-based large language models to solve problems.
  • Oral and written communication skills.
  • Leadership skills.
  • 15 years of pharmaceutical industry experience, including time designing and overseeing clinical trials and/or clinical development programs, or an equivalent combination of education and experience.
  • 7 years of people-management experience.
  • Immunology and/or rheumatology expertise.
  • Board certification or eligibility in immunology or rheumatology.

Responsibilities

  • Provide the primary physician perspective on the povetacicept immunology franchise and contribute scientific perspective to broader immunology portfolio decisions and mechanisms.
  • Provide project-team leadership in the design and implementation of clinical development programs.
  • Participate in planning and executing global clinical development activities, including establishing data monitoring committees, steering committees, and investigator meetings.
  • Represent the clinical development team at cross-functional meetings.
  • Develop study protocols.
  • Review Investigator Brochures.
  • Review and evaluate study subject exemptions.
  • Oversee medical monitoring of clinical studies.
  • Assist medical monitors in evaluating adverse events and safety profiles.
  • Participate in data reviews.
  • Participate in developing briefing books and preparing the team for regulatory interactions.
  • Interface with international regulatory authorities to support development objectives.
  • Ensure compliance with Vertex Standard Operating Procedures, International Conference on Harmonization, Good Clinical Practice, and other national and international regulatory requirements.
  • As a people manager, may have financial accountabilities and human resource responsibilities for assigned staff.

About the Company

Vertex Pharmaceuticals

Develops therapies for serious genetic diseases

Vertex Pharmaceuticals develops medicines for serious diseases, with a focus on cystic fibrosis. It conducts extensive research and partners with other biotech firms to discover and develop new therapies, including ex vivo engineered cell treatments. Its products, such as ivacaftor, treat cystic fibrosis and other therapies undergo clinical testing to expand the pipeline. Revenue comes from selling approved drugs and from licensing and collaboration agreements. The company distinguishes itself through deep R&D investment, strategic partnerships, and a global reach aimed at addressing unmet medical needs. The overall goal is to bring effective new drugs to patients worldwide and improve outcomes and quality of life.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Boston, MA
Founded
1989

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