Genentech - South San Francisco, CA

posted about 2 months ago

Full-time - Senior
South San Francisco, CA
Chemical Manufacturing

About the position

The Medical Director role at Roche's Clinical Development organization focuses on developing and executing late-stage clinical strategies for medically-differentiated therapies. This position involves supporting the Clinical Development Plan (CDP) for assigned molecules/indications, acting as a medical monitor for clinical studies, and collaborating with various internal and external stakeholders to ensure effective execution of clinical strategies.

Responsibilities

  • Support the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s).
  • Gather and analyze data and information necessary to create the CD plan.
  • Participate in the design, development, and execution of clinical studies.
  • Act as a medical monitor for assigned studies.
  • Collaborate with internal/external partners and multidisciplinary internal groups.
  • Provide clinical science input and guidance for early development/Phase I studies.
  • Review and provide late-stage input to Phase I & II protocols.
  • Assist in the completion and submission of regulatory filings and documentation.
  • Ensure strategic and operational alignment of the CD plan with relevant strategies and goals.
  • Develop CD plan components such as analytics/data strategy and publications strategy.

Requirements

  • MD, MBBS, MD/PhD with board-certified training in rheumatology or substantial rheumatology-specific research and clinical experience.
  • 2+ years of post-grad relevant clinical/scientific research and/or clinical trial experience.
  • Demonstrated experience (2+ years) in data analysis, interpretation, and clinical relevance.
  • Experience in scientific writing (e.g., manuscripts, grants, scientific protocols).
  • Outstanding communication skills in both long-form scientific presentation and short-form communication.

Nice-to-haves

  • Knowledge of the pharma/biotech industry and the drug development process.
  • Ability to collaborate with team members to measure and monitor study progress against objectives.
  • Strong interpersonal skills and the ability to influence internal partners and stakeholders.

Benefits

  • Discretionary annual bonus based on individual and company performance.
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