Clinical Research Lead

Clinical Research Lead W

Description

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

Cerenovus is recruiting for a Clinical Research Leader based in the United States. Primary location for this position is Irvine, California. Local candidate working 2-3 days/week in-office preferred. Remote may be considered.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong

This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

Key Responsibilities:

• Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Cerenovus;
• Generally manages work with limited supervision, dependent on project complexity.
• Management of limited number of direct reports
• Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
• Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision;
• Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
• Oversee the development and execution of Investigator agreements and trial payments;
• Responsible for clinical data review to prepare data for statistical analyses and publications;
• Responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
• Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Track and manage assigned project budgets to ensure adherence to business plans;
• Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy;
• Develop a strong understanding of the pipeline, product portfolio and business needs;
• Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;
• May serve as the primary contact for clinical trial sites (e.g. site management);
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;
• May contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
• May serve as the clinical representative on a New Product Development team;
• May contribute to the development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;
• May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;
• Perform other duties assigned as needed.

Qualifications

Education

• Minimum of a Bachelor's Degree required (preferably in Life Science, Physical Science, Nursing, or Biological Science)

Experience, Skills and Competencies:

Required:

• BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience
• Previous experience in clinical research or equivalent
• Experience working well with cross-functional teams
• Ability to travel up to 20% depending on the project phase
• Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
• Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
• Strong presentation and technical writing skills;
• Strong written and oral communication skills;
• Demonstrate competencies in the following area are required:

o Behave and lead in a professional and ethical manner

o Advanced technical writing skills

o Advanced project management skills with ability to handle multiple projects

Preferred:

• Medical device experience highly preferred
• Experience managing projects
• Experience managing direct reports
• Clinical/medical background a plus.

Leadership Competencies:

Ability to lead small study teams to deliver critical milestones, as may be assigned.

Leadership required in alignment with J&J Leadership Imperatives:

• Connect – Develop strong collaborative relationships with key internal and external stakeholders (i.e., physicians and research staff at project centers, third party vendors, regulatory agencies).
• Shape - Make recommendations for and actively participate and lead in departmental process improvement activities.
• Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
• Deliver - Strive to ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations.

This job posting is anticipated to close on 7/26/2024. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications

The anticipated base pay range for this position is to California Bay Area - The anticipated base pay range for this position is to

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

Vacation – up to 120 hours per calendar year

Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

#LI-RP1

Primary Location NA-US-California-Irvine

Other Locations NA-United States

Organization Medical Device Business Services, Inc (6029)

Job Function Clinical Development & Research & Non-MD

Req ID: W