The Opportunity:Drive Clinical Trial Design: Author clinical protocols and design early-phase (Phase I/II) studies to establish biologic and clinical proof-of-concept for novel molecular entities (NMEs).
Serve as Medical Monitor: Provide medical oversight, safety monitoring, and clinical expertise across active trials while collaborating with trial sites, investigators, and CROs.
Lead Cross-Functional Strategy: Represent Clinical Science on multi-disciplinary Clinical Science Teams (CST) and Protocol Execution Teams (PET), integrating insights across biomarkers, safety, regulatory, and commercial functions.
Guide Regulatory & Asset Strategy: Author clinical sections for INDs, IBs, and health authority briefing materials, supporting direct interactions with global regulatory bodies (FDA, EMA).
Engage Global Scientific Leaders: Collaborate with internal research groups, external Key Opinion Leaders (KOLs), and scientific advisory boards to refine disease area strategies and inform portfolio decisions.
Who You Are:
Clinical Expertise: M.D. with Board Certification or eligibility in Gastroenterology, Pulmonary, Rheumatology, Nephrology, or a related specialty (M.D./Ph.D. preferred).
Research Track Record: 2+ years of clinical, translational, or basic research experience within academia or the biopharmaceutical industry, with a demonstrated focus on immunology or inflammation.
Development Acumen: Thorough understanding of early clinical drug development principles (Phases I 6), trial methodology, GCP/ICH guidelines, and sophisticated clinical data interpretation.
Strategic & Collaborative Mindset: Adept at synthesizing complex biomarker and safety data to shape asset strategy and influence decisions across cross-functional matrix teams.
Scientific Communicator: Highly effective communicator capable of building strong collaborative networks with academic investigators, regulatory bodies, and internal research partners.
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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