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About the Role
The Early Clinical Development (ECD) OMNI group at Genentech drives innovation across a broad portfolio of immunology indications, advancing breakthrough science from First-in-Human studies through Proof-of-Concept and initial pivotal decisions. Our team translates complex biology into transformative therapies.
Responsibilities
- Author clinical protocols and design early-phase (Phase I/II) studies to establish biologic and clinical proof-of-concept for novel molecular entities (NMEs).
- Provide medical oversight, safety monitoring, and clinical expertise across active trials while collaborating with trial sites, investigators, and CROs.
- Represent Clinical Science on multi-disciplinary Clinical Science Teams (CST) and Protocol Execution Teams (PET), integrating insights across biomarkers, safety, regulatory, and commercial functions.
- Author clinical sections for INDs, IBs, and health authority briefing materials, supporting direct interactions with global regulatory bodies (FDA, EMA).
- Collaborate with internal research groups, external Key Opinion Leaders (KOLs), and scientific advisory boards to refine disease area strategies and inform portfolio decisions.
Requirements
- M.D. with Board Certification or eligibility in Gastroenterology, Pulmonary, Rheumatology, Nephrology, or a related specialty (M.D./Ph.D. preferred).
- 2+ years of clinical, translational, or basic research experience within academia or the biopharmaceutical industry, with a demonstrated focus on immunology or inflammation.
- Thorough understanding of early clinical drug development principles (Phases I–II), trial methodology, GCP/ICH guidelines, and sophisticated clinical data interpretation.
- Adept at synthesizing complex biomarker and safety data to shape asset strategy and influence decisions across cross-functional matrix teams.
- Highly effective communicator capable of building strong collaborative networks with academic investigators, regulatory bodies, and internal research partners.
Skills
- Immunology
- Inflammation
- Early clinical drug development
- Biomarker data interpretation
- Safety data interpretation
- Clinical data interpretation
- GCP/ICH guidelines
- Regulatory affairs
- Communication
- Collaboration
Location
- South San Francisco, California
Work Type
- Hybrid
Experience Level
- 2+ years of clinical, translational, or basic research experience
Education Level
- M.D.
- M.D./Ph.D.
Salary/Compensations
- $213,400 - $396,200
Benefits
- Relocation benefits
- Discretionary annual bonus
- Comprehensive benefits package
About the Company
- We advance science so that we all have more time with the people we love.
- Genentech is an equal opportunity employer.
Equal Opportunity
- 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.
- If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.