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Arvinas is a biotechnology company pioneering targeted protein degradation therapies using its proprietary PROTAC Discovery Engine platform. The company recently achieved the first FDA approval of a PROTAC protein degrader, marking a major milestone in the field. Arvinas is building a broad pipeline across oncology and neurodegenerative diseases, including programs targeting LRRK2 for Parkinson's disease and progressive supranuclear palsy (PSP).
The Senior Director, Clinical Scientist will provide scientific and clinical leadership for global clinical development activities in neurodegenerative disease, with initial focus on Parkinson's disease and PSP. This is a senior leadership role requiring program-level scientific ownership, independent judgment, and the ability to influence cross-functional and governance decisions.
Key responsibilities include:
**Clinical Development Strategy & Study Planning:** Lead clinical development plans, target product profiles, and indication strategies for Parkinson's disease, PSP, and related neurodegenerative disorders. Partner with clinical research physicians to design Phase 1-3 studies, with emphasis on early-phase, proof-of-mechanism, and proof-of-concept development. Guide selection and interpretation of outcome measures (MDS-UPDRS, PSP Rating Scale, cognitive/functional measures, quality-of-life instruments, patient-reported outcomes, digital measures). Contribute to statistical analysis plans, case report forms, data-review plans, and endpoint-quality strategies. Collaborate with cross-functional teams on study start-up, including CRO/vendor selection, central laboratory and imaging onboarding, and independent committee activities.
**Clinical Document Development:** Lead development of clinical study protocols and synopses. Contribute to investigator brochures and regulatory documents. Lead or contribute to clinical study reports, development safety update reports, regulatory briefing documents, and responses to health-authority questions. Contribute to presentations, publications, abstracts, posters, manuscripts, and congress presentations.
**Study Conduct & Data Interpretation:** Monitor study progress and data quality. Interpret emerging safety, pharmacokinetic, pharmacodynamic, biomarker, imaging, and clinical data to inform dose selection, study design, and program decisions. Communicate complex scientific concepts clearly in writing and formal presentations to internal and external experts.
**Cross-Functional Collaboration:** Work closely with Clinical Operations, Biostatistics, Data Management, Translational Sciences, Clinical Pharmacology, Pharmacovigilance, Regulatory, Research, and other functions. Engage with investigators, vendors, partners, and external experts.
The role reports to the Head of Clinical Sciences and can be hybrid at headquarters in New Haven, CT, or remote from a US location. Approximately 20% domestic and international travel is anticipated.
**REQUIREMENTS:**
**Education:**
- Advanced scientific or clinical degree required
- Doctoral-level degree (PhD) preferred; MSc/MPH with extensive directly relevant experience may be considered
**Experience:**
- Substantial clinical-development experience, preferably including leadership of global early-phase, proof-of-mechanism, and proof-of-concept studies in neurodegenerative disease
- Strong scientific background with demonstrated ability to translate emerging safety, pharmacokinetic, pharmacodynamic, biomarker, imaging, and clinical data into dose selection, study design, and program decisions
- Experience leading or contributing to Phase 1-2 clinical-development or randomized proof-of-concept studies
- Experience with longer-term, placebo-controlled disease-progression studies is desirable
- Experience with relevant neurodegeneration endpoints and assessments (PSP Rating Scale, MDS-UPDRS, cognitive/global assessments, quality-of-life measures, MRI, fluid biomarkers, patient/caregiver-reported outcomes)
- Experience with disease-modifying development programs and biomarker strategies involving tau, alpha-synuclein, lysosomal biology, genetically defined mechanisms, biologics, small molecules, or targeted protein degradation
- Experience addressing scientific and operational complexities of multinational studies, including regional differences in standard of care, site capabilities, rater qualification, endpoint implementation, participant/caregiver burden, and regulatory expectations
- Desirable: experience with central or remote rater programs, digital biomarkers, wearable sensors, imaging endpoints, CSF sampling, independent monitoring committees, and interactions with FDA, EMA, or other health authorities
**Other Requirements:**
- Ability to work without need for current or future visa sponsorship
- Strong communication skills (written and verbal) for complex scientific concepts
- Creativity, independence, strategic insight, attention to detail
- Comprehensive knowledge of clinical drug development activities and procedures
