Medical Director: Gastroenterology, Pulmonary, Rheumatology, Nephrology
Roche
Summary
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. Driven by gRED's mission to make fundamental scientific discoveries and help develop them into best-in-class therapeutics that provide unique benefits to patients, our team translates complex biology into transformative therapies.
Job description
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–II), 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.
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
- Demonstrated focus on immunology or inflammation
- Thorough understanding of early clinical drug development principles (Phases I–II)
- Trial methodology knowledge
- GCP/ICH guidelines knowledge
- Sophisticated clinical data interpretation skills
- Adept at synthesizing complex biomarker and safety data
- Ability to 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
Benefits
- Relocation benefits
- Annual bonus
- Medical, Dental & Vision
- 401(k) Matching
- Unlimited PTO
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.