Senior Director, Clinical Scientist -Neuroscience

Role Summary

The Clinical Scientist is responsible for providing scientific support for all Global Clinical Development activities. This role includes assembling, evaluating, and presenting scientific and medical data, writing or providing content to clinical documents, monitoring the competitive landscape and reviewing and summarizing relevant literature to provide strategic input. The position requires strong scientific background, clear written and verbal communication to scientific and medical experts, independent work, and a detailed knowledge of clinical drug development. The role collaborates with Clinical Operations, Translational Sciences, Clinical Pharmacology, Regulatory, Research and other functions within Arvinas, as well as external partners, and may be hybrid in New Haven, CT or remote within the U.S.

Responsibilities

• Clinical Document Development
  • Lead development of clinical study protocol synopses and full protocols, engaging with internal/external subject matter experts on study design and endpoints
  • Contribute to the clinical portion of investigator brochures review for consistency and applicability
  • Contribute in writing and review of clinical study reports, DSURs, annual reports, and regulatory briefing books
  • Manage development of internal and external presentations/publications (manuscripts, posters, etc.) of clinical study data
  • Participate in publication planning
  • Contribute to writing departmental working processes (SOPs, templates, etc)
• Clinical Study Planning
  • Assist clinical research physician in developing clinical development plans
  • Contribute to development of data collection tools, SAPs, CRFs
  • Collaborate with cross-functional study teams to ensure timely study start-up including CRO selection, DMC/IIR activities, Central Lab on-boarding, etc
• Study Data Review and Analysis
  • Lead development of Medical Monitor Plans
  • Perform ongoing clinical data review and critical analysis of study data
  • Partner with Clinical Operations, Translational Medicine, Pharmacovigilance, Data Management and other teams to ensure quality and timely study conduct
  • Provide support for clinical and scientific issues during study execution
  • Work with biostatisticians and programmers to plan analyses
  • Support data summaries for leadership and advisory board meetings
• Review of Scientific Literature
  • Perform literature searches and summarize relevant scientific, drug development, and medical literature to support documents
  • Provide scientific/medical materials to in-house staff and external consultants
  • Identify and review literature addressing topics relevant to Arvinas drug candidates

Qualifications

• Required: Advanced doctoral-level degree preferred (PhD, MD, MSc/MPH, PharmD); BS/MS with relevant experience may be considered
• 10+ years of experience in a pharmaceutical company environment
• Neurodegenerative/neuromuscular disease experience required
• Advanced knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operations in neurodegenerative/neuromuscular disease settings
• Excellent project management, communication, and organizational skills; ability to lead cross-functional projects
• Strong collaborative, independent-working capability and timely delivery of high-quality objectives
• Ability to work in a home or corporate office environment and use computer, video, and electronic communications; adaptable during standard business hours

Skills

• Scientific writing and presentation
• Clinical development and regulatory document preparation
• Cross-functional collaboration
• Data review and basic biostatistics coordination

Education

• Advanced doctoral degree preferred (PhD, MD, PharmD, MSc/MPH); equivalent relevant experience considered

Additional Requirements

• U.S. work authorization (no visa sponsorship provided now or in the future)