Senior/Executive Medical Director, Clinical Development (New Indications)
Alumis
7 months ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
- Lead clinical development strategy and execution for Phase 1 and Phase 2 studies evaluating envudeucitinib and A-005 across new indications.
Responsibilities
Clinical Development Strategy & Leadership
- Lead the design, planning, and execution of Phase 1 and Phase 2 clinical studies for A-005 and additional pipeline molecules in new therapeutic indications
- Develop and refine clinical development plans (study synopses, protocols, and integrated development strategies)
- Provide clinical and scientific leadership to cross-functional study teams to align on goals, timelines, and deliverables
- Collaborate with Translational Medicine and Research to evaluate and prioritize new indication opportunities based on scientific rationale, competitive landscape, and unmet need
Study Execution & Oversight
- Serve as the Medical Monitor for assigned Phase 1 and 2 studies to ensure patient safety and scientific integrity
- Oversee medical aspects of study conduct (safety surveillance, protocol amendments, and data review)
- Partner with Clinical Operations, Biostatistics, and Regulatory Affairs for efficient execution and high-quality data generation
- Lead interactions with Data Safety Monitoring Boards (DSMBs) and provide input for safety analyses
Regulatory & External Engagement
- Contribute to regulatory strategy and represent the company with FDA and international authorities (EMA, PMDA, etc.)
- Prepare and review clinical sections of regulatory submissions (IND amendments, briefing documents, meeting packages)
- Represent the company at scientific conferences, advisory boards, and with KOLs
- Build and maintain relationships with investigators and academic collaborators
Cross-Functional Collaboration
- Integrate biomarker strategies into clinical study designs with Translational Sciences, Biomarker, and Pharmacology
- Collaborate with Commercial and Medical Affairs on disease landscape assessments and indication prioritization
- Provide clinical expertise to support business development (partnerships, in-licensing)
Team Development
- Mentor and develop junior medical staff
- Contribute to building clinical development capabilities as the organization grows
Required Qualifications (Skills/Experience)
- MD required; board certification or fellowship training in Rheumatology, Dermatology, or related specialty strongly preferred
- 10+ years of pharmaceutical/biotechnology industry experience in clinical development with a focus on immunology/autoimmune diseases
- Demonstrated experience leading Phase 1 and Phase 2 studies from design through data readout
- Track record of successful regulatory interactions (FDA, EMA) and experience preparing IND/CTA submissions
- Deep understanding of early clinical development (dose-finding, biomarker integration, adaptive trial designs)
- Strong scientific acumen to evaluate preclinical/clinical data
- Excellent leadership, communication, and interpersonal skills in a matrixed environment
- Strategic mindset balancing scientific rigor with business objectives
Preferred Qualifications
- Experience with indication expansion or lifecycle management for immunology assets
- Experience at a small or mid-sized biotech; comfortable in fast-paced, resource-conscious environments
- Established KOL relationships in rheumatology, dermatology, or gastroenterology
- Experience across multiple autoimmune indications (e.g., psoriasis, psoriatic arthritis, lupus, atopic dermatitis, CNS inflammatory/degenerative diseases)
- Familiarity with expedited regulatory pathways (Breakthrough Therapy, Fast Track)
Benefits
- Health insurance premiums: 90% employee, 80% dependents
- Free access to Genentech Bus & Ferry Share program
- $100 monthly cell phone stipend
- Unlimited PTO for Exempt employees
- Free onsite gym and a kitchen stocked with snacks and drinks
Travel Requirements
- ~20–30% travel for investigator meetings, conferences, regulatory interactions, and site visits
Location/Work Arrangement
- South San Francisco, CA; onsite Tuesday–Thursday; remote considered case-by-case
Compensation (as stated)
- Salary range: $300,000–$400,000 USD annually
Other compensation
- Generous stock option grants and annual bonus program
- Lead clinical development strategy and execution for Phase 1 and Phase 2 studies evaluating envudeucitinib and A-005 across new indications.
Responsibilities
Clinical Development Strategy & Leadership
- Lead the design, planning, and execution of Phase 1 and Phase 2 clinical studies for A-005 and additional pipeline molecules in new therapeutic indications
- Develop and refine clinical development plans (study synopses, protocols, and integrated development strategies)
- Provide clinical and scientific leadership to cross-functional study teams to align on goals, timelines, and deliverables
- Collaborate with Translational Medicine and Research to evaluate and prioritize new indication opportunities based on scientific rationale, competitive landscape, and unmet need
Study Execution & Oversight
- Serve as the Medical Monitor for assigned Phase 1 and 2 studies to ensure patient safety and scientific integrity
- Oversee medical aspects of study conduct (safety surveillance, protocol amendments, and data review)
- Partner with Clinical Operations, Biostatistics, and Regulatory Affairs for efficient execution and high-quality data generation
- Lead interactions with Data Safety Monitoring Boards (DSMBs) and provide input for safety analyses
Regulatory & External Engagement
- Contribute to regulatory strategy and represent the company with FDA and international authorities (EMA, PMDA, etc.)
- Prepare and review clinical sections of regulatory submissions (IND amendments, briefing documents, meeting packages)
- Represent the company at scientific conferences, advisory boards, and with KOLs
- Build and maintain relationships with investigators and academic collaborators
Cross-Functional Collaboration
- Integrate biomarker strategies into clinical study designs with Translational Sciences, Biomarker, and Pharmacology
- Collaborate with Commercial and Medical Affairs on disease landscape assessments and indication prioritization
- Provide clinical expertise to support business development (partnerships, in-licensing)
Team Development
- Mentor and develop junior medical staff
- Contribute to building clinical development capabilities as the organization grows
Required Qualifications (Skills/Experience)
- MD required; board certification or fellowship training in Rheumatology, Dermatology, or related specialty strongly preferred
- 10+ years of pharmaceutical/biotechnology industry experience in clinical development with a focus on immunology/autoimmune diseases
- Demonstrated experience leading Phase 1 and Phase 2 studies from design through data readout
- Track record of successful regulatory interactions (FDA, EMA) and experience preparing IND/CTA submissions
- Deep understanding of early clinical development (dose-finding, biomarker integration, adaptive trial designs)
- Strong scientific acumen to evaluate preclinical/clinical data
- Excellent leadership, communication, and interpersonal skills in a matrixed environment
- Strategic mindset balancing scientific rigor with business objectives
Preferred Qualifications
- Experience with indication expansion or lifecycle management for immunology assets
- Experience at a small or mid-sized biotech; comfortable in fast-paced, resource-conscious environments
- Established KOL relationships in rheumatology, dermatology, or gastroenterology
- Experience across multiple autoimmune indications (e.g., psoriasis, psoriatic arthritis, lupus, atopic dermatitis, CNS inflammatory/degenerative diseases)
- Familiarity with expedited regulatory pathways (Breakthrough Therapy, Fast Track)
Benefits
- Health insurance premiums: 90% employee, 80% dependents
- Free access to Genentech Bus & Ferry Share program
- $100 monthly cell phone stipend
- Unlimited PTO for Exempt employees
- Free onsite gym and a kitchen stocked with snacks and drinks
Travel Requirements
- ~20–30% travel for investigator meetings, conferences, regulatory interactions, and site visits
Location/Work Arrangement
- South San Francisco, CA; onsite Tuesday–Thursday; remote considered case-by-case
Compensation (as stated)
- Salary range: $300,000–$400,000 USD annually
Other compensation
- Generous stock option grants and annual bonus program