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Arvinas · 5 hours ago

Senior Director, Clinical Scientist -Neurodegenerative disease

New Haven, CT

Full-time

Hybrid

Director/Executive

10+ years exp

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating diseases. The Senior Director, Clinical Scientist will provide scientific support for Global Clinical Development activities, including developing clinical documents and collaborating with various teams to ensure successful study execution.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Growth Opportunities

No H1B

Responsibilities

Lead the development of clinical study protocol synopses and full protocols, including engage with subject matter experts (internal and external) on study design elements and endpoints

Contribute to the clinical portion of investigator brochures review for consistency and applicability

Contribute in the writing and review of clinical study reports (CSRs), data safety update 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 of departmental working processes (SOPs, templates, etc)

Assist clinical research physician in developing clinical development plans

Contribute to the development of data collection tools, statistical analysis plans (SAPs), case report forms (CRFs)

Collaborate with cross-functional study team to ensure timely study start-up including CRO selection, Data monitoring committee/Independent Radiology Reviewer activities, Central Lab on-boarding etc

Lead development of Medical Monitor Plans

Perform ongoing clinical data review and critical analysis of study data including partnering with clinical research physician

Partner with Clinical Operations, Translational Medicine, Pharmacovigilance, Data management and other functional team members at assure quality and timely study conduct and monitoring

Provide support as needed for clinical and scientific issues that may arise during study execution

Work closely with biostatisticians and programmers to plan analyses of clinical data

Support data summaries for leadership, advisory board meetings, etc

Perform literature searches and critically review and summarize the relevant scientific, drug development and medical literature to support document development, such as the investigator brochure, protocol design, clinical study report, competitive assessments, etc

Provide scientific/medical supportive materials to in-house staff and external consultants in the indications being studied

Identify and review literature that addresses specific topics of interest relevant to Arvinas drug candidates

Qualification

Neurodegenerative disease experienceGCP/ICH knowledgeDrug development processClinical operations knowledgeStudy design expertiseStatistics knowledgeProject management skillsCommunication skillsOrganizational skillsTeam playerIndependent work ability

Required

Advanced, doctoral level degree preferred such as PhD, MD, MSc/MPH, PharmD, BS/ MS with relevant professional experience may be considered

10+ years of experience within a pharmaceutical company environment required

Neurodegenerative/neuromuscular disease experience /educational background required

Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations in the neurodegenerative/neuromuscular disease setting required

Excellent project management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross-functional teams

Passionate commitment and a strong team player

Ability to work independently and reliably deliver objectives of high quality in a timely manner

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 and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

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