Offers “Roche”

41 days agoRoche

Group Medical Director (MD), Early Development Gastroenterology

  • San Francisco (City and County of San Francisco)
  • Teaching

Job description

·  Job facts

Genentech's Early Clinical Development organization is structured by therapeutic area and is responsible for developing and executing early clinical strategies and plans (phase I and II) that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Group Medical Director:

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Leads a group of medical directors and clinical science specialists as direct reports.

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Leads the development of the assigned therapeutic area's scientific and clinical strategies and plans.

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The therapeutic area of the group that this individual will lead is gastrointestinal, hepatology and infectious disease. The candidate should have expertise in gastroenterology/hepatology.

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Accountable for programs within the therapeutic area of the group. Provides guidance to direct reports on the programs that they lead.

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Guides the development of and approves Clinical Development strategies, priorities, final interpretation and completion of clinical study results.

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Serves on the OMNI (Ophthalmology, Metabolism, Neurosciences, Immunology and Infectious Diseases) Leadership Team.

Required Qualifications

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MD with relevant medical experience in gastroenterology/hepatology

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8 + years of pharma/biotech industry experience OR is a recognized expert in the field

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2+ years experience managing medical/clinical staff

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6+ years clinical trial experience with expert knowledge of Phase I - II drug development

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Experience submitting an IND/IMPD/CTA to regulatory authorities in Europe and/or the U.S.

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4+ years experience authoring global clinical development plans and publishing results of clinical drug trials in referred journals

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Experience in basic research and data interpretation in area of relevance

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Comprehensive understanding of product and safety profiles

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In-depth knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

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In-depth understanding of competitive activity in the field

Preferred Qualifications

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MD/PhD

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Multidisciplinary experience in the pharma or biotech industry (e.g., research, regulatory, clinical operations, business development, commercial operations, etc.)

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Current or past leadership roles in major scientific and advocacy organizations and standard-setting bodies

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Strong academic/teaching background

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Phase III clinical trial experience

#hepatology #gastroenterology #pharmajobs

·  Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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