Senior Director, Clinical Lead Alzheimer's Disease - Neuroscience

Johnson & Johnson•Cambridge, MA

11d

About The Position

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Neuroscience team tackles the world’s toughest brain health challenges including multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, myasthenia gravis, epilepsy, major depressive disorder, bipolar disorder, schizophrenia, and autism. This patient-focused team helps address some of the most complex diseases of our time. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine POSITION SUMMARY: The incumbent will serve as a Senior Director, Clinical Leader in Neurodegeneration, Neuroscience, with a focus on innovative late phase drug development for Alzheimer’s Disease projects. They will provide strategic, clinical, and scientific support and be accountable for the execution of the clinical strategy, serving as the leader of the cross functional clinical team and a core member of the compound development team (CDT).

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.
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.

Nice To Haves

Board certification (or equivalent) in a relevant specialty is strongly preferred

Responsibilities

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.