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Medical Affairs Group

Global Medical Affairs Leader, Director, Dermatology

  • 標題 Global Medical Affairs Leader, Director, Dermatology
  • 功能 Medical Affairs Group
  • 子功能 Medical Affairs - MD
  • 類別 Director, Medical Affairs - MD (PL9)
  • 位置 Horsham, Pennsylvania, United States; Spring House, Pennsylvania, United States
  • 刊登日期
  • 參考 2406179906W
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描述

Johnson & Johnson Innovative Medicine, Immunology Global Medical Affairs, is recruiting for a Global Medical Affairs Leader (GMAL), Director, Dermatology, located in Horsham, Pennsylvania or Spring House, Pennsylvania.

The Global Medical Affairs Leader (GMAL), Director, Dermatology, under the direction of the Head of Global Medical Affairs for Dermatology, is responsible for leading the clinical-commercial optimization of product development and life cycle management strategies and plans for the assigned marketed compounds and compounds in clinical development within the Immunology TA. The GMAL will lead the Global Medical Affairs Team and partner closely with Regional Medical TA/product leaders to develop integrated Global Medical Affairs perspectives, strategies and plans for specified products, assets, and projects. The GMAL, will be a member of the Compound Development Teams (CDTs), the Safety Management Teams (SMTs) and Global Commercial Teams (GCTs), as well as an ad hoc member of the Clinical Team and Global Market Access Team, and will be responsible for development of the Global Medical Affairs plan that reflects prioritized regional needs and are included in the overall compound development plan. In addition, the GMAL will be accountable for the global publications plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for assets starting in early development (phase IIA) and through launch of major life cycle management initiatives (earlier or later as needed). The GMAL will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally.

Key Responsibilities:

Develop Global Medical Affairs strategy and plan for the assigned compounds based on prioritized regional needs. Working with the CDT ensures integration with the overall global compound strategy, resulting in one Global R&D and Medical Affairs compound development plan, inclusive of developing a Target Product Profile representing Medical Affairs global and regional value needs.

Provide a single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV.

Be responsible for pre-launch Medical Affairs activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, and coordination of regional activity in these areas.

Be an active member of the CDT and lead a Global Medical Affairs Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one Medical Affairs perspective and one “unified” voice on the CDT.

Collaborate closely with the regional Medical Affairs representatives to develop integrated Global Medical Affairs strategies and plans and maintain open, two-way communication to ensure regional Medical Affairs is up to date on all plans, progress and decisions.

Synchronize input and output of the Medical Affairs plan with the strategic and business plan calendars.

Maintain responsibility for the development and execution of global publication plans as well as review and approval of publications for marketed products and specified compounds in clinical development

Lead the ReCAP process (review of all Medical Affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products.

Support development of the Company risk management strategy and plan as well as author and review specific sections of the Periodic benefit-risk assessment report for compounds. Perform medical impact assessments as required.

Maintain responsibility for ensuring that all global activities follow J&J Compliance principles (eg. Health Care Compliance etc.)

資格

Education:

  • A minimum of a Pharm D., Ph.D or MD degree (or equivalent) is required with specialty training and certification in dermatology preferred.

Experience and Skills:

Required Experience: 

  • Extensive clinical and/or pharmaceutical experience in Immunology is required. Experience in dermatology disease areas and having an established network with medical experts/opinion leaders in dermatology are highly preferred.
  • A minimum of 5 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required; at least three years in the Medical Affairs environment is highly desirable.
  • Knowledge of products, both J&J and competitors, in the Therapeutic Area.
  • A demonstrated track record of success within Medical Affairs and/or Clinical R&D.
  • In-depth knowledge of study methodology, study data reviews and analysis.
  • Excellent knowledge of study execution, benefit risk management and regulatory affairs.
  • Proven ability to act as a medical spokesperson for external audiences is required. Also required is strong experience developing and managing strategic relationships with medical experts/opinion leaders.
  • Proven track record on ethics and Credo principles.

Required Competencies/Skills:

  1. Strategy Development Expertise
  2. Adaptability and Flexibility / Managing internal and external relationships
  3. Product Development Expertise and Product/Brand Awareness
  4. Organization and Project Management
  5. Customer and Market Insight

Other:

  • Proficiency in the English language is required.
  • This position is USA-based, with 20-25% or more travel in the US and internationally.
  • Co-location with Immunology Therapeutic Area R&D and GCSO teams in Spring House/Horsham, Pennsylvania is required.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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