Senior Director, Clinical Lead - Neurodegeneration/Parkinson's

Johnson & Johnson•Titusville, MA

14d

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. 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 Clinical Leader in Neurodegeneration, Neuroscience, with a focus on innovative drug development for neurodegenerative disorders. 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 disorders including Parkinson’s disease is required.
Requires at least 10 years of experience in clinical research and development.
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.
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

Experience interacting with global health authorities is strongly preferred (FDA, EMA etc)
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.
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.

Benefits

medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
Company’s consolidated retirement plan (pension) and 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