Medical Director, Neuroscience - Early Clinical Development (ECD)

Genentech

Daly City, CAFull-time

Behavioral Health Market Context

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Qualifications

  • •Qualified Neurologist: M.D./D.O. with a completed Neurology residency and at least two years of post-residency experience diagnosing and treating neurological disorders
  • •Research Driven: Strong foundational experience in basic, translational, or clinical research with an understanding of Phase 1 and 2 drug development
  • •Analytical Expert: Proficient in data analysis, interpretation, and assessing the clinical relevance of study results
  • •Effective Communicator: Excellent written and verbal skills, with the ability to present complex data to internal governance committees and scientific advisory boards
  • •Collaborative Leader: Proven ability to work across multi-disciplinary functions (e.g., biostatistics, regulatory, commercial) to design and implement Clinical Development Plans (CDPs)
  • •Regulatory Knowledgeable: Well-versed in global medical guidelines and regulations, including GCP, ICH, FDA, and EMEA
  • •3 more items(s)

Responsibilities

  • •In this role, you will serve as a standing member or leader of Clinical Subteams (CSTs) and represent Clinical Science on cross-functional Protocol Execution Teams (PETs) to ensure alignment and effective execution of clinical development strategies and plans
  • •You may also act as the Medical Monitor for assigned studies, serving as the primary point of contact for clinical operations, CROs and study investigators regarding medical questions, safety data, and study progress
  • •You will support the critical transition of NMEs from Research into Early Development, contributing directly to key regulatory documents such as the Investigational New Drug (IND) application, Investigator Brochure (IB), and Phase 1 protocols
  • •Working with oversight from senior Medical Directors and/or Clinical Scientists, you will design clinical studies, author clinical sections of protocols, and drive the cross-functional protocol development process
  • •Shape the Strategy: Enable critical decisions regarding early clinical development, including design of first-in-human and pivotal studies
  • •Lead Innovation: Drive non-molecule work such as novel endpoint development and observational studies
  • •Portfolio Impact: Participate in business development assessments for potential acquisitions and strategic partnerships in neurological indications including, but not limited to multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis
  • •Medical Oversight: Act as the Medical Monitor for assigned studies, serving as the primary point of contact for clinical operations, CROs, and investigators
  • •Regulatory Leadership: Contribute directly to key regulatory documents, including IND applications, Investigator Brochures (IB), and Phase 1 and Phase 2 protocols
  • •6 more items(s)
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