Senior Director, Clinical Lead – Alzheimer's Disease, Neuroscience
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • Massachusetts, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $232,000 - $401,350 per year
Job Level
Senior
About the role
- Provides active medical and scientific contribution to a matrixed cross-functional Compound Development Team and the Clinical Team.
- Team matrix interactions may include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business-related disciplines.
- Lead the clinical team and be responsible for timely completion, content and quality of key documents eg clinical development plans, protocol development, execution of clinical studies, preparation of clinical study reports and for the preparation and approval of essential documents for regulatory filings.
- Working with functional partners responsible for the clinical development strategy for the assigned development program(s) and accountable for its execution.
- Providing leadership on managing/addressing specific project/program-related issues and presenting to and negotiating with the NS and Johnson and Johnson Innovative Medicine, Research & Development leadership teams on development plans or program-related issues.
- Working with global clinical operations, Regulatory, and Global Medical Safety, leads the clinical team in responding to medical and compound-related issues.
- Working with Regulatory Affairs and global clinical operations to respond to questions from Health Authorities and IRBs/ECs.
- Provides key input to statistical analysis plans and the interpretation of statistical analyses.
- Presenting and/or responding to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations.
- Provides key input into diligence activities.
- Supervises direct reports if assigned.
- Participates or leads cross-departmental or cross-functional projects with broad Johnson and Johnson Innovative Medicine impact.
- Builds professional relationships with opinion leaders, investigators and key regulatory officials.
- May act as company spokesperson regarding publication of research findings and presentations to relevant health authorities and consultant/advisory meetings.
Requirements
- MD (or equivalent) is required.
- Detailed and thorough understanding of neurodegenerative diseases, specifically Alzheimer's Disease is required.
- Requires at least 10 years of experience in clinical research and development (including Phase 2-3b studies).
- Experience interacting with global health authorities is strongly preferred (FDA, EMA etc).
- Exceptional interpersonal and communication skills, with the ability to build strong relationships and influence without reporting authority.
- Excellent problem-solving and conflict resolution skills, with the ability to navigate complex and challenging situations.
- Up to 20% annual travel (domestic and international) may be required.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchclinical developmentprotocol developmentclinical studiesstatistical analysisregulatory filingsclinical pharmacologybiostatisticshealth economicsepidemiology
Soft skills
interpersonal skillscommunication skillsproblem-solvingconflict resolutionleadershiprelationship buildinginfluence without authoritynegotiationproject managementteam collaboration
Certifications
MD