Lead Medical Director, Early Clinical Development, Immunology

United States of America, California, South San Francisco

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Summary

The Early Clinical Development (ECD) OMNI group at Genentech is seeking a talented Physician Scientist for the early clinical development work focused on gastroenterology & hepatology, nephrology, and immunology.  ECD OMNI oversees a broad portfolio and drives development from first-in-human studies through proof-of-concept and decision-making regarding initial pivotal studies.  The gRED Lead Medical Director participates in development of clinical strategies for the assigned molecule(s)/indication(s) and is responsible for developing and ensuring effective and efficient execution of the clinical development program (CDP).  gRED Lead Medical Directors  are able to lead multiple projects and may have one or more direct reports. 

 

Job Responsibilities 

Clinical Development Planning

  • Leads the development of the CDP for assigned molecules 

  • May lead clinical and disease area strategy development, collaborating with a variety of internal and external partners and stakeholders  

  • Effectively articulates the clinical development strategy and navigates probability of success, time and cost tradeoffs

  • Collaborates with Research for target compound profile development to enable the success of future early development to IND decisions

  • Supports the transition of new molecules from research into early development, then into clinical development, including contributing to the regulatory documents and Health Authority interactions

  • Collaborates with Biomarker Development at research stages for predictive and pharmacodynamic biomarker strategy

  • Participates in meetings, reviews, discussions and other interactions regarding late stage development studies to provide early development insight and guidance

  • Participates in competitive intelligence and due diligence projects  

Clinical Development Plan Implementation

  • Accountable for execution of the CDP for assigned molecules

  • Provides clinical oversight across all relevant studies and programs:

    • Designs and develops protocols for early stage clinical studies to obtain proof of concept

    • Acts as medical monitor for assigned studies

    • Collaborates with drug safety to develop the product safety profile and with regulatory in the completion and submission of regulatory documents

    • Plays a lead role in development of investigator brochures, safety reports, IND reports 

    • Plays a lead role in the planning, development and implementation of external-facing communications strategies to support existing and concluded studies, including publications, advisory boards and other external presentations

Cross-Functional Team Leadership & People Management

  • Leads one or more the Clinical Science Teams (CSTs) which consists of cross-functional team members

  • As appropriate, can effectively delegate, mentor and oversee Clinical Science (CS) representation in cross-functional teams relevant to assigned molecules and helps ensure cross-functional integration, coordination and alignment to enable effective and efficient CDP execution

  • Where applicable, may manage one or more direct reports and is, in such instances, responsible for hiring, training, developing and retaining talent on his/her staff.  

     

Job Requirements

Qualifications And Experience 

  • M.D. with board certification, or eligibility, in Gastroenterology, Hepatology, Nephrology, or related specialty

  • 4 or more years pharma/biotech industry experience and clinical trial experience

  • Is a clinician-scientist expert in the field, preferably with laboratory research experience

  • Excellent written and verbal communication skills

  • Strong interpersonal and influencing skills along with knowledge of biotechnology industry

  • Aptitude or proven ability to manage others