Position Summary

The Senior Director, Clinical Scientist is responsible for providing scientific and clinical leadership for global clinical development activities in neurodegenerative disease, with an initial focus on Parkinson's disease and progressive supranuclear palsy (PSP). The role will assemble, evaluate, interpret, and present scientific and medical data; lead or provide content for clinical documents; monitor the competitive landscape; critically review relevant literature; and provide strategic input to clinical development programs and studies.

The successful candidate will combine a strong scientific background with substantial clinical-development experience, preferably including leadership of global early-phase, proof-of-mechanism, and proof-of-concept studies in neurodegenerative disease. Experience translating emerging safety, pharmacokinetic, pharmacodynamic, biomarker, imaging, and clinical data into dose selection, study-design, and program decisions is particularly important. The individual must communicate complex concepts clearly in writing and in formal presentations to scientific and medical experts inside and outside Arvinas. This role requires creativity, independence, strong strategic insight, attention to detail, and comprehensive knowledge of the activities and procedures involved in clinical drug development.

This is a senior leadership role requiring program-level scientific ownership, independent judgment, and the ability to influence cross-functional and governance decisions. The Senior Director will collaborate with Clinical Operations, Biostatistics, Data Management, Translational Sciences, Clinical Pharmacology, Pharmacovigilance, Regulatory, Research, and other functions within Arvinas, as well as investigators, vendors, partners, and external experts. Working closely with the Clinical Development Lead, the Senior Director will have a substantial role in development strategy, study design and execution, clinical document development, review and interpretation of clinical data, and communication of results to scientific, medical, regulatory, and patient communities.

This position reports to the Head of Clinical Sciences and can be hybrid at our headquarters in New Haven, CT, or remote from a location within the U.S.

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:
Clinical Development Strategy and Study Planning

• Provide clinical-science leadership for clinical development plans, target product profiles, indication strategies, evidence-generation plans, and program-level decision making in Parkinson's disease, PSP, and related neurodegenerative disorders.
• Partner with the clinical research physician to design global Phase 1-3 studies, with particular emphasis on early-phase, proof-of-mechanism, and proof-of-concept development, including population and disease-stage definitions, dose and regimen selection, estimands, endpoints, visit schedules, safety monitoring, biomarker and imaging plans, and participant/caregiver burden.
• Guide selection and interpretation of relevant outcome measures, including the MDS-UPDRS, PSP Rating Scale, clinical global assessments, cognitive and functional measures, quality-of-life instruments, patient- and caregiver-reported outcomes, and digital measures, as applicable.
• Contribute to data-collection tools, statistical analysis plans, case report forms, data-review plans, rater-training plans, and endpoint-quality strategies.
• Collaborate with cross-functional study teams to enable timely study start-up, including CRO and vendor selection, central laboratory and imaging onboarding, rater qualification mechanism, and Data Monitoring Committee or other independent committee activities.

Clinical Document Development

• Lead development of clinical study protocol synopses and full protocols, engaging internal and external subject-matter experts on study design, endpoints, biomarkers, and operational feasibility.
• Contribute to clinical portions of investigator brochures and review documents for scientific consistency, accuracy, and applicability.
• Lead or contribute to clinical study reports, development safety update reports, annual reports, regulatory briefing documents, responses to health-authority questions, and other clinical and regulatory deliverables.
• Contribute to development of internal and external presentations and publications, including abstracts, posters, manuscripts, congress presentations, advisory-board materials, and investigator-meeting content.
• Participate in publication planning and contribute to departmental working processes, standard operating procedures, templates, and best practices.

Study Conduct, Data Review, and Analysis

• Provide senior clinical-science leadership from study start-up through closeout, including support for investigator and site training, enrollment and retention strategies, eligibility review, protocol deviation assessment, and resolution of clinical and scientific questions.
• Lead development of medical monitoring and clinical data-review plans in partnership with the clinical research physician and safety colleagues.
• Perform ongoing review and critical analysis of blinded and unblinded efficacy, safety, biomarker, imaging, pharmacokinetic, and pharmacodynamic data; integrate emerging findings to support dose selection, escalation or expansion decisions, study adaptation, and program strategy; and identify trends, inconsistencies, and questions requiring cross-functional action.
• Responsible for processes for rater qualification, scale-administration standards, central review, inter-rater variability, data completeness, and missing-data mitigation in longitudinal neurodegeneration studies.
• Partner with Clinical Operations, Translational Sciences, Pharmacovigilance, Data Management, Biostatistics, Statistical Programming, and other functions to assure high-quality and timely study conduct, analysis, and reporting.
• Support interpretation and communication of emerging benefit-risk information and prepare clear data summaries and recommendations for senior leadership, governance committees, advisory boards, investigators, and regulators.

Scientific and External Engagement

• Perform literature searches and critically review and summarize scientific, drug-development, clinical, and regulatory literature to support protocols, investigator brochures, clinical study reports, competitive assessments, and development strategy.
• Monitor the neurodegeneration treatment landscape and emerging approaches in movement-disorder trial design, progression endpoints, biomarkers, imaging, digital measures, and patient-focused drug development.
• Build productive relationships with movement-disorder investigators, key opinion leaders, patient advocacy organizations, clinical research networks, and external partners; support advisory boards and investigator meetings.

Qualifications

• 10+ years of relevant pharmaceutical or biotechnology clinical-development experience, including substantial experience with global interventional studies and demonstrated leadership of early-phase clinical development; equivalent combinations of education and experience will be considered.
• Demonstrated clinical-development experience in neurodegenerative disease or movement disorders required, with meaningful experience in Parkinson's disease, PSP, atypical parkinsonism, tauopathies, or closely related conditions strongly preferred.
• Strong knowledge of ICH-GCP, the drug-development process, study design, statistics, clinical operations, and global regulatory expectations in neurodegenerative disease required.
• Working knowledge of longitudinal efficacy endpoints, clinical rating scales, rater variability, disease progression, placebo effects, missing data, and operational challenges in neurodegeneration trials required.
• Excellent project leadership, communication, and organizational skills, with demonstrated success leading matrix teams, exercising independent judgment, and influencing program-level and cross-functional decisions.
• Ability to interpret complex clinical and biomarker data and communicate conclusions, limitations, and recommendations to technical and nontechnical audiences.
• Strong team orientation, passionate commitment to patients and caregivers, and ability to work independently and reliably deliver high-quality objectives on time.

Preferred Experience

• Demonstrated leadership of global early-phase clinical-development studies, including Phase 1, Phase 1b, or early proof-of-mechanism/proof-of-concept studies conducted across multiple countries or regions. Direct experience in neurodegenerative disease is strongly preferred.
• Experience designing or leading early-phase studies that integrate safety, pharmacokinetics, pharmacodynamics, biomarkers, imaging, dose and regimen selection, and preliminary clinical activity to inform study and program decisions.
• Direct experience with a global PSP or Parkinson's disease study, including an early clinical-development or randomized proof-of-concept study. Experience with longer-term, placebo-controlled disease-progression studies is also desirable.
• Experience with relevant neurodegeneration endpoints and assessments, such as the PSP Rating Scale, MDS-UPDRS, cognitive and global assessments, quality-of-life measures, MRI or fluid biomarkers, and patient- or 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 the scientific and operational complexities of multinational studies, including regional differences in standard of care, site capabilities, rater qualification, endpoint implementation, participant and caregiver burden, and regulatory expectations. 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 is desirable.

Work Environment and Employment Requirements

The duties of this role are generally conducted in a home or corporate office environment. Employees must be able, with or without accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours. Domestic and international travel may be required, anticipated at approximately 20%.

Arvinas will not be providing visa sponsorship for this position now or in the future. Candidates must have the ability to work without a need for current or future visa sponsorship.

EDUCATION

• Advanced scientific or clinical degree required
• Doctoral-level degree such as PhD preferred. An MSc/MPH with extensive directly relevant experience may be considered.

#LI-Remote

Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com