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Early Clinical Development (ECD) at gRED is where groundbreaking science meets its first clinical application. This organization is responsible for bridging the gap between research discovery and late-stage development, transforming New Molecular Entities (NMEs) into potential medicines for patients. As a Medical Director in ECD OMNI, you will be at the center of this transition, designing and executing the first trials that provide essential proof-of-concept data regarding safety, efficacy, and biomarker utility in humans, with a focus in our neuroimmunology and neurodegeneration portfolios.
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.
The Opportunity:
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.
Who You Are:
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.
Relocation benefits are available for this posting.
Onsite presence, on our South San Francisco campus, is expected for at least 3 days a week.
The expected salary range for this position based on the primary location of South San Francisco, California is $213,400 - $396,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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