Director, Late Development Clinical Lead - Raritan, United States - Johnson & Johnson

Johnson & Johnson Raritan, United States

1 week ago

Description

Johnson & Johnson is recruiting for a Director, Clinical Leader - Retina to be located in Raritan, NJ .

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

The incumbent will serve as a Clinical Leader in the Retina therapeutic area, with a focus on drug development for retinal projects.

The initial effort will be towards a first-in-class gene therapy program for age-related macular degeneration, a prevalent and blinding condition, and provide strategic, clinical, and scientific support through all phases of clinical development.

The 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 input to and implementation of the Clinical Development Plan
Working with functional partners responsible for the clinical development strategy for the assigned development program(s)
Providing 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
Provides key input into diligence activities
Participates or leads cross-departmental or cross-functional projects with broad Janssen impact.
Builds credible relationships with external partners (e.g. principal investigators, sub-investigators and opinion leaders) and may act as company spokesperson regarding publication of research findings and presentations to relevant health authorities and consultant/advisory meetings.

Clinical Operations Lead

3 weeks ago

Everest Clinical Research Services Inc Bridgewater Township, United States Full time

Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies ...
Director, Late Development Clinical Lead

1 week ago

J&J Family of Companies Raritan, United States

Director, Late Development Clinical Lead - Retina W · **Description** · Johnson & Johnson is recruiting for a **Director, Clinical Leader - Retina** to be located in **Raritan, NJ** . · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation e ...
Director, Late Development Clinical Lead

4 days ago

Johnson & Johnson Somerville, United States

Job Description · Johnson & Johnson is recruiting for a Director, Clinical Leader - Retina to be located in Raritan, NJ . · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are pr ...
Clinical Lead

3 weeks ago

Kindred Healthcare Hartsville, United States

Carolina Pines Regional Medical Center has been an integral part of the lives of people throughout Darlington County and the surrounding areas for over 20 years. Our 116-bed hospital offers a full range of inpatient, outpatient and emergency room ser Clinical, Healthcare, Patient ...
Lead Qc Microbiology Data Reviewer

3 weeks ago

Legend Biotech US Raritan, United States

**Company Information** · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, includ ...
Clinical Study Lead

3 weeks ago

ShiftCode Analytics Basking Ridge, United States

CLINICAL STUDY LEAD · 6+ MONTHS CONTRACT · BASKING RIDGE, NJ / TARRYTOWN, NY · HYBIRD (3 DAYS/WEEK) · VISA- NO CPT/H1B · The Temp Senior Clinical Study Lead (CSL) - Clinical Experimental Sciences Operations (CES Ops) is accountable for the execution of assigned clinical stud ...
Associate Director, Clinical Sciences

1 day ago

Johnson & Johnson Raritan, United States

Johnson & Johnson is recruiting for an **Associate Director, Clinical Project Scientist - Ophthalmology **to be located in **Raritan, NJ, Spring House, PA, Cambridge, MA, or La Jolla, CA **. Remote work options may be considered on a case-by-case basis and if approved by the Comp ...
Global Medical Affairs Leader Actions

2 days ago

Johnson & Johnson Raritan, United States

The Global Medical Affairs Medical Director/GMAL for Lung and Head & Neck cancer will be responsible for leading aspects of the clinical-commercial optimization for assets in development and life cycle management strategies under the guidance of the Senior Global Medical Affairs ...
International Logistics Analyst

2 days ago

QuidelOrtho Raritan, United States

The Opportunity · QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are mo ...
Director, Technical Accounting

2 days ago

QuidelOrtho Raritan, United States

The Opportunity · QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are mo ...
Area Director

3 days ago

Johnson & Johnson Raritan, United States

**Overall Responsibilities**: · Ethicon is seeking an **Area Director **for its U.S Commercial organization, directly supporting the field selling organization. The Area Director will play a key role in shaping strategy and ensuring commercial execution across the field organizat ...
Contract Validation Analyst

2 days ago

QuidelOrtho Raritan, United States

The Opportunity · QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are mo ...
Clinical Site Lead

3 weeks ago

Novo Nordisk A/S Plainsboro, United States

Responsible for operational aspects of managing clinical site performance through coordination and communication with CSS - As, CRAs and the Trial Manager (TM) for assigned trials, within the Therapy Area T of North America Clinical Development (NACD Clinical, Lead, Monitoring, O ...
Clinical Development Lead

3 weeks ago

Bristol-Myers Squibb Princeton, NJ, United States

Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line t ...
Clinical Lead Therapist

1 week ago

Staffosaurus Bayonne, United States

Job Description · Job DescriptionClinical Lead Therapist · About Us · We are a leading provider of mental health and substance abuse treatment services, dedicated to transforming lives and communities through compassionate care and evidence-based practices. As a reputable organiz ...
Clinical Site Lead

3 weeks ago

BioSpace Plainsboro, United States

Job Details · About the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies wi ...
Clinical Development Lead

3 weeks ago

Bristol-Myers Squibb Company Princeton, United States

**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a productio ...
Clinical Lead Therapist

2 weeks ago

Staffosaurus Bayonne, United States

About the job Clinical Lead Therapist · Clinical Lead Therapist · About Us · We are a leading provider of mental health and substance abuse treatment services, dedicated to transforming lives and communities through compassionate care and evidence-based practices. As a reputab ...
Clinical Site Lead

3 weeks ago

Novo Nordisk Plainsboro, United States Full time

About the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to p ...
Clinical Development Lead

1 week ago

Bristol-Myers Squibb Company Princeton, United States

**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...