Project Physician, Director
Johnson & Johnson Family of Companies
Lisboa, PT
há 5 dias
source : Ofertas de Emprego

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.

We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

Learn more at www.janssen.com and follow us JanssenGlobal.

Janssen GPH (Global Public Health) utilizes the resources, capabilities, pharmaceuticals, technologies, and programs of Janssen R&D to bring new innovations to impact the health and well-being of underserved communities globally.

The GPH portfolio includes SIRTURO (bedaquiline), the first new drug for the treatment of tuberculosis in 40 years, as well as projects in HIV treatment, Dengue prevention and treatment, COVID-19 and a Long-Acting formulation platform for diverse infectious diseases.

Position summary :

The Project Physician is responsible for design and execution of Ph1 / 2 / 3 studies in Mycobacterial infections disease area including tuberculosis and leprosy.

As the project physician you will provide active medical and scientific contribution to a cross-functional clinical team.

Providing input to the clinical development plan, the development of the clinical trial protocol, clinical trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory filings.

Team matrix interactions include project management, finance, legal, quality assurance & compliance, clinical supplies, regulatory affairs, data management, medical writing, biostatistics, global safety, global medical affairs, clinical operations and other scientific and business related fields.

You contribute to the evaluation of scientific opportunities in the therapeutic area and represent Janssen on external research collaborations.

Essential functions :

  • Responsible for medical monitoring / reporting and company safety officer activities
  • Works on clinical development plans, trial protocols and takes ownership of clinical study reports
  • Evaluates adverse events (pre / post-marketing) for relationship to treatment
  • Assisting Regulatory Affairs (RA) in determining requirements for any corrective actions or health authority reporting
  • May act as a medical contact at the company for health authorities concerning clinical / medical issues
  • Interpreting, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
  • Close interactions with Project Scientists and Physicians across programs
  • Other responsibilities / detailed duties :

  • Assisting RA in the development of drug regulatory strategies
  • Helping explore and evaluate new product ideas to assist in identifying new market opportunities
  • Supporting Clinical / Medical Affairs activities involving product evaluation, labeling and surveillance
  • Participating on and may lead cross-functional teams for evaluation of new product ideas.
  • Reviews medical literature and related new technologies
  • May be asked to assess medical publications emerging from the Team and its affiliates
  • May contribute to managing external research collaborations and applications for external funding
  • Qualifications

    Do you have the following skills, experience and education required for this role?

  • Medical Degree or equivalent.
  • Specialization, industry experience, or clinical experience.
  • Experience of Global Public Health is a plus.
  • Experience of running / designing clinical studies (in industry setting) is preferred. Experience running industry sponsored studies at a clinical trial site will also be considered
  • Solid understanding of the use of Microsoft suite of software products including Excel and Word
  • Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
  • Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

    Please contact us to request accommodation.

    Primary Location

    United Kingdom-England-High Wycombe-50-100 Holmers Farm Way

    Other Locations

    Netherlands, Norway, Czech Republic, Denmark, Italy, Portugal, Sweden, United States, Austria, Belgium, Germany, Spain, Estonia, Finland, France, Ireland

    Organization

    Janssen Cilag Ltd. (7360)

    110620201

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