Experience Inc. Jobs

Job Information

J&J Family of Companies Sr. Director, Clinical Leader Ophthalmology, Phase 3 Gene Therapy in Raritan, New Jersey

Janssen is recruiting for a Sr. Director, Clinical Leader Ophthalmology, Phase 3 Gene Therapy for the Inherited Retinal Disease Program to be based ins Raritan, NJ or Springhouse, PA

Primary Responsibilities:

Serve as a Clinical Leader in the Cardiovascular/Metabolism/Retina (CVMR), with a focus on drug development for retinal projects. The initial effort will be towards a first-in-class pivotal stage program with Accelerate to Value (ATV) status at Janssen indicating its importance to the organization.

  • Provide strategic, clinical, and scientific leadership of through all phases of clinical development

  • The Sr. Director will have broad responsibilities including:

  • 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.

  • Accountable for the design and implementation of the Clinical Development Plan

  • Working with functional partners responsible for the clinical development strategy for the assigned development program(s)

  • Providing strategic leadership on managing/addressing specific project/program-related issues and presenting to and negotiating with the CVMR and Janssen leadership teams on development plans or program-related issues

  • Working with Global Clinical Operations (GCO), Regulatory, and Global Medical Safety, leads the clinical team in responding to medical and compound-related issues

  • Working with Regulatory Affairs and GCO with regard to responses to questions from Health Authorities and IRBs/ECs

  • Leading the clinical team, responsible for the timely completion, content, and quality of key deliverables including protocols, reports and submissions to health agencies

  • Supervising and contributing to the timely completion and quality of clinical study reports, including providing 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

  • Participates or leads cross-departmental or cross-functional projects with broad Janssen impact.

  • Builds credible relationships with opinion leaders and may act as company spokesperson regarding publication of research findings and presentations to relevant health authorities and consultant/advisory meetings.

Qualifications

  • MD (or equivalent) is required.

  • Board certification in Ophthalmology is preferred

  • Excellent oral and written communication and presentation skills are required.

  • The ability to work with cross-functional teams in a matrix environment is required.

  • Detailed and thorough understanding of retinal disorders, including inherited retinal diseases, retinal vascular diseases and degenerative diseases of the macula is preferred.

  • Requires at least 7 years of experience in clinical research and development (including Phase 2-3b studies).

  • Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings are required.

  • Up to 15% annual travel (domestic and international) may be required.

Primary Location

United States-New Jersey-Raritan-920 US Highway 202

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105934218W

DirectEmployers