Senior Director, Clinical Lead – Neurodegeneration

Role Overview

• 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 e.g. 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 Alzheimer’s disease is required.
• Requires at least 10 years of experience in clinical research and development, especially in drug development for CNS indications.
• 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.
• Strategic mindset.
• Experience and interest in innovative clinical trial design.
• Fluent in written and spoken English.
• Working knowledge of the use of Microsoft suite of software products including Excel and Word.
• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings.
• Outstanding interpersonal and communication skills.
• Experience in leading people (directly and in a matrix) of varying levels via coaching and open conversations to reach their full potential, while also providing support and guidance during periods of poor performance.
• Excellent problem-solving and decision-making abilities.

Benefits

• medical
• dental
• vision
• life insurance
• short
• and long-term disability
• business accident insurance
• group legal insurance
• retirement plan (pension)
• savings plan (401(k))
• long-term incentive program
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours