Responsibilities:
- Serve as Translational Medicine Lead across programs; set portfolio strategy linking mechanism of action to clinical outcomes.
- Partner with Program Team Leaders and Clinical Development to define translational hypotheses, proof-of-mechanism/POC strategies, and decision criteria.
- Lead translational prioritization, resource planning, and execution in a lean biotech environment.
- Build and lead a Translational Medicine organization spanning biomarker science, bioinformatics/omics, assay development/operations, and sample/data strategy.
- Develop and execute biomarker strategies for target engagement/pathway modulation, pharmacodynamics, patient stratification, and disease biology/progression/response.
- Integrate biomarkers into clinical protocols (fluid biomarkers, imaging, functional measures, exploratory omics).
- Oversee development, qualification, and validation of translational assays (including vendor selection, governance, quality oversight).
- Lead integration/interpretation of multi-modal datasets (clinical, biomarkers, imaging, omics) with Biometrics and Data Sciences.
- Provide translational leadership across flagship/next-wave programs (GBS tanruprubart/ANX005; GA ophthalmology/vonaprument/ANX007; neurodegeneration; TBI/myasthenic crisis; autoimmune neuromuscular including MG, MMN, CIDP).
- Contribute translational content to IND/CTA and BLA/MAA modules and briefing packages; provide oversight for abstracts/manuscripts/study reports.
- Represent the company externally with KOLs/academia/consortia/CROs and at scientific meetings.
- Collaborate cross-functionally (Discovery, Translational Sciences, Clinical Development/Operations, Biometrics, Regulatory, Medical, Commercial); provide updates to executive leadership.
Qualifications/Skills:
- MD, PhD, or MD/PhD (advanced training strongly preferred).
- 15+ years in pharma/biopharma with leadership responsibility across Translational Medicine/Biomarkers and/or Clinical Development interfaces.
- Proven track record leading translational medicine organizations (team building, biomarker plans, influencing clinical decisions).
- Deep domain expertise in immunology/rheumatology and/or neurology/neuroimmunology and/or ophthalmology.
- Expertise in biomarker strategy, assay development/qualification, clinical sample strategy/operations, and translational data integration (multi-omic and imaging).
- Experience partnering with Regulatory Affairs and supporting regulatory interactions; filings success is a plus; companion diagnostic development desirable.
- Strong leadership/interpersonal skills; excellent communication/presentation; strategic business acumen.
Benefits:
- Flexible work schedules and remote opportunities.
- Shuttle service from BART, CalTrain, and the Ferry.
- Competitive base salary and equity participation; employee stock purchase plan; comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans, and other benefits).